Devices In China Research Articles

Factors affecting the willingness of college students in Mainland China to pay for mobile learning

With the increasing popularity of mobile internet technology and devices in China, mobile learning is on the rise. College students, the main users of smart devices, have become consumers. Based on the theory of perceived value, this study uses social factors (including interpersonal influence and online word of mouth) and personal payment awareness to build a model of students' willingness to pay for mobile learning, aiming to explore its determinants. The results show that personal payment awareness, perceived value, and interpersonal influence have a significant impact on their willingness to pay. Among them, perceived quality, perceived mobility value, and perceived value have significant positive correlations, while perceived risk and perceived value have significant negative correlations.

Factors affecting the willingness of college students in mainland China to pay for mobile learning

With the increasing popularity of mobile internet technology and devices in China, mobile learning is on the rise. College students, the main users of smart devices, have become consumers. Based on the theory of perceived value, this study uses social factors (including interpersonal influence and online word of mouth) and personal payment awareness to build a model of students' willingness to pay for mobile learning, aiming to explore its determinants. The results show that personal payment awareness, perceived value, and interpersonal influence have a significant impact on their willingness to pay. Among them, perceived quality, perceived mobility value, and perceived value have significant positive correlations, while perceived risk and perceived value have significant negative correlations.

Development the Miniaturized AMS System and Its Analysis Technique

Accelerator mass spectrometry(AMS) is the most sensitive analytical technique for measuring long-lived radionuclides, which is widely used in the fields of environment, geology, archaeology and physics. In recent years, the miniaturization of AMS device has been greatly developed in the world. In order to develop miniaturized AMS devices and their analysis technology, China institute of atomic energy has independently developed a single-stage AMS device with an acceleration voltage of 0.2 MV and a tandem AMS device with an terminal voltage of 0.3 MV, respectively. Based on the single-stage AMS device, the high efficiency transport technique and background eliminating method have been developed for 14C measurement, and realized the high sensitivity measurement of 14C. The measurement sensitivity reaches 14C/12C (atomic number ratio)=2×10–15. Using the 0.3 MV tandem AMS device, the gas stripping conditions, background eliminating and detection methods of 129I at low ion energy were systematically studied, and the high efficient transmission and high sensitive measurement methods of 129I were established, the sensitivity is 129I/127I=1×10–14. This is the first time to develop miniaturized AMS devices in China, which lays the foundation for the localization of AMS.

Analysis of a SVC Device Filter Capacitor Bank Circuit Breaker Explosion

When SVC device is in operation mode, it can provide fast dynamic reactive power compensation for the system when the power grid is disturbed greatly, and it can improve the voltage stability of the system. With the growing popularity of SVC devices in China, it is particularly important to study the faults of SVC devices in the process of operation. In this paper, the recent explosion of filter capacitor bank breaker in SVC device of a substation which was put into operation earlier in China is analyzed in detail. Through the inspection of equipment after failure, combined with the background of computer monitoring system, relay protection, and fault recording, the failure process is analyzed, and finally five preventive measures are put forward. It can provide guidance for the operation and maintenance of other station capacitor bank breakers, especially for the station capacitor bank breakers installed with SVC device, so as to ensure the safe and stable operation of the power grid.

Study on the characteristic of light transmission in a single-multimode fiber

Based upon the optical coherence superposition principle, a system to acquire light transmitted by a single-multimode fiber has been built. By collecting the optical interference images and using MATLAB software for analysis, the target light transmitted by a single-multimode optical fiber can be extracted from it. Thus, the transmission characteristics of light in a single-multimode optical fiber can be obtained, aiming to realize the direct transmission imaging through the multimode optical fiber by the compensation principle according to the change of phase in the transmission process and to provide technical support for the development of medical examination and medical devices in China.

Effect of Online Product Presentation on the Purchase Intention of Wearable Devices: The Role of Mental Imagery and Individualism-Collectivism.

The main objective of this study was to investigate how and when online product presentation influences individual purchase intention of wearable devices in China. This study hypothesized that online product presentation would influence individual mental imagery, which, in turn, would impact purchase intention through perceived social risk and positive emotion, but this effect would be moderated by individualism–collectivism value at the individual level. We performed a laboratory experiment (2 × 2) to collect the data (N = 254). The experimental results indicated that there was a significant interaction effect between the product feature presentation video and usage scenario presentation picture on mental imagery. In addition to a direct effect, mental imagery had an indirect effect on purchase intention through perceived social risk and positive emotion. Additionally, the behavioral effect of perceived social risk was moderated by individualism–collectivism. Specifically, compared with individualists, perceived social risk had a stronger impact on collectivists’ purchase intention. This study contributes to a greater understanding of the mechanism through which online product presentation drives purchase intention, with a particular emphasis on how individualism–collectivism value at the individual level moderates consumers’ intention to purchase wearable devices.

Research status and development trend of seed-metering device in China

As the main tool of soybean mechanization production, the performance of soybean seeder is directly related to the sowing quality and yield of soybean.As the core component of the seeder, the soybean seed-metering device directly affects the seeding accuracy, uniformity, seed emergence rate, etc.This article introduces the research status and future development trend of soybean seed-metering devices in China in recent years, analyzes the characteristics of soybean seed-metering devices in China, and provides a basis for the further development of seed metering devices in China.

Research status of Rice direct seeding device in China

Aiming at the problems of rice seedling raising, transplanting and so on, low production efficiency and low mechanization efficiency, we popularize the rice direct seeding technology, through investigating and studying the development status of representative rice direct seeding machine in China, analyze its basic structure and working principle, and put forward the existing problems and development suggestions of rice direct seeding machine. Research shows that rice direct seeding technology has a broad development space in China. It is necessary to further optimize the design of key components such as seed metering devices and improve independent research and development capabilities to improve the versatility and efficiency of the rice direct seeding machine, so that China’s rice direct seeding technology can Rapid development.

Building an innovation system of medical devices in China: Drivers, barriers, and strategies for sustainability.

Objectives:This article aimed to discuss the emergence of medical device sector in China from a sectoral innovation system perspective, to explore the drivers and barriers to the successful building of an innovation system of medical devices, and to highlight the policy implications and suggestions for sustainable innovation of medical devices.Methods:A theoretical framework of sectoral systems of innovation was applied in the analysis of data, and materials were collected from multiple sources with particular attention paid to the evolutionary phases, structure, and function of the innovation system.Results:The evolution of medical device sector in China could be divided into four phases: initialization (1960s–1970s); exploration (1980s); steady growth (1990s); and rapid growth (since 2000). Through analyzing the innovation system’s structural components of technology, actors, and networking, as well as institutions, this study indicated that the government policy decision was the most important driver that affected the virtuous cycle of the Chinese medical device innovation system, followed by market demand and entrepreneurial activities. However, barriers against the innovation cycle such as knowledge base development and diffusion, legitimacy, and resource mobilization still remained.Conclusion:In its endeavor to build an innovation system, the Chinese medical device sector had made some progress in meeting the local medical demands and improving its industrial competence. Although a Chinese innovation system for medical devices was initiated under the guidance of the government, knowledge advancement and diffusion had become the main challenges for the sustainability of innovation in this sector. The future development depends on China’s effort and ability to establish education and health research systems specific to medical devices.

Consideration and Practice of Introducing Third-party Certification Institutions to Participate in Post-marketing Supervision of Medical Devices

After years of international regulatory practice, the third party certification bodies have become an important social force in the field of medical devices supervision. It is broadly discussed how to introduce social resources to play an active role in the supervision of medical devices under the regulatory system of medical devices in China. Shanghai Medical Products Administration has carried out research and preliminary practice on the participation of third-party institutions in post-marketing supervision of medical devices. The article mainly focuses on purpose, entry point, inspection criteria and result disposal of introducing the participation of third-party institutions in the post-marketing supervision, meanwhile, discusses the next work direction at the same time.

Translational status of biomedical Mg devices in China

Magnesium (Mg) and its alloys as temporary medical implants with biodegradable and properly mechanical properties have been investigated for a long time. There are already three kinds of biodegradable Mg implants which are approved by Conformite Europeene (CE) or Korea Food and Drug Administration (KFDA), but not China Food and Drug Administration (CFDA, now it is National Medical Products Administration, NMPA). As we know, Chinese researchers, surgeons, and entrepreneurs have tried a lot to research and develop biodegradable Mg implants which might become other new approved implants for clinical applications. So in this review, we present the representative Mg implants of three categories, orthopedic implants, surgical implants, and intervention implants and provide an overview of current achievement in China from academic publications and Chinese patents. We would like to provide a systematic way to translate Mg and its alloy implants from experiment designs to clinical products.

Psychosocial Factors Affecting Artificial Intelligence Adoption in Health Care in China: Cross-Sectional Study.

BackgroundPoor quality primary health care is a major issue in China, particularly in blindness prevention. Artificial intelligence (AI) could provide early screening and accurate auxiliary diagnosis to improve primary care services and reduce unnecessary referrals, but the application of AI in medical settings is still an emerging field.ObjectiveThis study aimed to investigate the general public’s acceptance of ophthalmic AI devices, with reference to those already used in China, and the interrelated influencing factors that shape people’s intention to use these devices.MethodsWe proposed a model of ophthalmic AI acceptance based on technology acceptance theories and variables from other health care–related studies. The model was verified via a 32-item questionnaire with 7-point Likert scales completed by 474 respondents (nationally random sampled). Structural equation modeling was used to evaluate item and construct reliability and validity via a confirmatory factor analysis, and the model’s path effects, significance, goodness of fit, and mediation and moderation effects were analyzed.ResultsStandardized factor loadings of items were between 0.583 and 0.876. Composite reliability of 9 constructs ranged from 0.673 to 0.841. The discriminant validity of all constructs met the Fornell and Larcker criteria. Model fit indicators such as standardized root mean square residual (0.057), comparative fit index (0.915), and root mean squared error of approximation (0.049) demonstrated good fit. Intention to use (R2=0.515) is significantly affected by subjective norms (beta=.408; P<.001), perceived usefulness (beta=.336; P=.03), and resistance bias (beta=–.237; P=.02). Subjective norms and perceived behavior control had an indirect impact on intention to use through perceived usefulness and perceived ease of use. Eye health consciousness had an indirect positive effect on intention to use through perceived usefulness. Trust had a significant moderation effect (beta=–.095; P=.049) on the effect path of perceived usefulness to intention to use.ConclusionsThe item, construct, and model indicators indicate reliable interpretation power and help explain the levels of public acceptance of ophthalmic AI devices in China. The influence of subjective norms can be linked to Confucian culture, collectivism, authoritarianism, and conformity mentality in China. Overall, the use of AI in diagnostics and clinical laboratory analysis is underdeveloped, and the Chinese public are generally mistrustful of medical staff and the Chinese medical system. Stakeholders such as doctors and AI suppliers should therefore avoid making misleading or over-exaggerated claims in the promotion of AI health care products.

Clinical Trial Assessment Principles of National Class III Medical Devices in China.

Class III medical devices are defined as those which are implanted inside the human body and applied to maintain normal life and retain original tissue or organic functions. Because these devices are associated with high risk, their effectiveness and safety should be strictly monitored and clinically investigated. The aim of clinical investigation of these medical devices is to ensure the acceptability of their effectiveness and safety levels. On designing the clinical trial, the investigator should determine the indices to assess the effectiveness and safety of medical devices, select reasonable data‐analyzing methods, and pay attention to several other issues. Although some guidelines on specific class III medical devices have illustrated those aspects in detail, there is still no comprehensive report that details all those principles and methodologies. This article aims to summarize the common features among the instruction principles and provide technological support for the clinical study of class III medical devices.

Lead fixation in deep brain stimulation: comparison of three lead anchoring devices in China

BackgroundThe accuracy of deep brain stimulation (DBS) depends on precise electrode positioning, which has been pursued for ideal treatment outcomes. As a critical component of DBS, the fixation performance of lead anchoring devices has been widely studied. Possible reasons for lead shift were analyzed in the current study and we further provided effective solutions to reduce potential manual errors.MethodsSeventy-nine patients who received DBS implantations at the Ruijin Hospital from April to November 2017 were retrospectively reviewed. Intraoperative lead shifts were measured by C-arm fluoroscopy. Lead adjustment counts were recorded and compared among three lead fixation devices: Stimloc™ (Medtronic, Minneapolis, MN, USA), TouchLoc (SceneRay, Suzhou, China), and the traditional lead anchoring device.ResultsMean (± SD) distances of lead shifts were 0.29 ± 2.42 mm in Stimloc devices, 0.43 ± 0.55 mm in TouchLoc devices, and 1.52 ± 1.05 mm in traditional devices (p < 0.0001). Average numbers of adjustments in this series were 0.3 ± 0.5 in Stimloc devices, 0.3 ± 1.3 in TouchLoc devices, and 1.1 ± 1.0 in traditional devices (p = 0.0001). Pairwise comparisons among the three devices (TouchLoc vs. Stimloc: p = 0.273; TouchLoc vs. Traditional: p = 0.0001; Stimloc vs. traditional: p < 0.0001) suggested significant differences, which were mainly attributed to the traditional devices.ConclusionsThree lead anchoring devices have been compared for their performance in the accuracy of lead fixation, in which the newly designed lead fixation devices have presented its advantages to the traditional one. In addition to the application of the Stimloc and TouchLoc devices, verification by C-arm fluoroscopy should be performed to provide an intuitive view of the depth deviation of electrode position during DBS electrode implantation.

Some Advances in Theory and Experiment of High-Frequency Vacuum Electron Devices in China

The advances of high-frequency vacuum electron devices (VEDs) in China are reviewed in this paper, including traveling-wave tubes (TWTs) based on novel slow-wave structures (SWSs), high harmonic TWT amplifier, gyrotrons, Smith-Purcell (SP) radiation sources, surface plasmon polaritons (SPPs) sources, and terahertz (THz) radiation sources in ion-focused beam-plasma system. As one of the most widely used VEDs, TWTs based on folded type SWSs, planar SWSs, and grating type SWSs are studied theoretically and experimentally from Ka-band to R-band. Using folded type SWSs, two TWT amplifiers are developed. As high-power millimeter wave and THz wave sources, gyrotron TWTs, gyrotron oscillators, and gyroklystrons are presented. Moreover, this paper shows SP radiation sources, SPPs sources, and THz radiation sources in ion-focused beam-plasma system open good prospects for developing high-frequency VEDs with new mechanisms, which undoubtedly brings about innovative changes for the development of VEDs.

Reprocessing and reuse of single-use medical devices in China: a pilot survey

BackgroundIn China, reprocessing and reuse of single-use medical devices (SUDs) are banned. However, the actual situation has not been reported so far. The study aims to clarify the perceptions and concerns of various sectors of the community on the reuse of SUDs, and whether such practice exists. In addition, we are also wondering how acceptable the respondents are on this matter.MethodsA cross-sectional study based on a national survey which was conducted on the professional online questionnaire survey platform (www.wjx.cn) from July 26 to August 4, 2015. We analyzed the data according to the work fields, sex, age, education level, professional background and participants’ answers to 49 other questions.ResultsFive hundred forty-four nationwide respondents belong to nine different work fields. In general, participants had positive attitudes towards the reprocessing and reuse of SUDs. However, many respondents doubted the hygienic and functional safety of the reprocessed SUDs. They also tended to think that the reuse of SUDs should have lower prices and more technical training as well as patient advocacy. Further analysis demonstrated the work fields, education level and professional background of respondents were statistically associated with their responses to certain questions.ConclusionsThe research indicated that although the reuse of SUDs is prohibited legally in China, there were extensive reprocessing and reuse in hospitals. Most responses tended to accept reprocessed SUDs if safety and low prices were guaranteed. These existing contradictions and the lack of relevant research led to policy makers in China will confront numerous challenges in building and improving this use system of medical devices to meet escalating demands of social sectors.

Analysis on Re-classifcation Management Procedure of Medical Devices in the United States

A detailed analysis on re-classification procedure of medical devices from Food and Drug Administration.The experience on classification procedures,the work-flow of risk reanalysis and regulatory categories reassessment of listed products,as well as launching a comprehensive evaluation and downgrading of listed high-risk products were explored in recent years.Based on the analysis on classification procedures and supervision of medical device products in the USA,and combined with the current situation of classification of medical devices in China,some suggestions were put forward on the current classification mode of medical devices so as to improve the quality and efficiency of classified management of medical devices in China.

Study on ripple effect of ferromagnetic WCCB blanket modules in CFETR

China Fusion Engineering Test Reactor (CFETR), the next fusion device in China, is proposed to bridge the gaps between ITER and the demonstration reactor (DEMO). The Water Cooled Ceramic Breeder (WCCB) blanket, one candidate option of breeding blanket conception for CFETR, impacts the toroidal field (TF) ripple in CFETR, as the reduced activation ferritic/martensitic (RAFM) steel was used as its structure material. The purpose of this paper is to investigate and evaluate the ripple effect of WCCB blanket on TF ripple in CFETR. An analysis is performed using three-dimensional finite element model with 16 TF coils and WCCB blanket modules. ANSYS code is employed for this study. The results indicated that the TF ripple was less than 0.5% at all points in target separatrix when it was estimated with TF coils only. We also calculated TF ripple in case of WCCB blanket modules and various port configuration schemes. It is found that TF ripple cannot meet the design requirements by the presence of WCCB blanket modules, even in difference port configuration. Discussions are made on the implication of the WCCB blanket modules and ports on TF ripple. Potential methods for reducing the TF ripple are studied in this paper.

Comparison of 2 Different Drug-Coated Balloons in In-Stent Restenosis: The RESTORE ISR China Randomized Trial

ObjectivesThe aim of the present study was to evaluate the angiographic efficacy, clinical safety, and effectiveness of the Restore paclitaxel-coated balloon in a randomized trial designed to enable the approval of the new device in China. BackgroundDrug-coated balloon (DCB) angioplasty offers an effective treatment for in-stent restenosis. Restore is a new DCB with a SAFEPAX shellac-ammonium salt excipient that can avoid drug washing off during catheter delivery to the target lesion site. MethodsIn the noninferiority RESTORE ISR China (Compare the Efficacy and Safety of RESTORE DEB and SeQuent Please in Chinese Patient With Coronary In-stent Restenosis) trial, eligible patients with first occurrence of drug-eluting stent ISR were randomized to the Restore DCB or SeQuent Please DCB in a 1:1 ratio stratified by diabetes. Angiographic and clinical follow-up was planned at 9 months and 1 year, respectively, in all patients. The study was powered for the primary endpoint of 9-month in-segment late loss. ResultsBetween May 2016 and July 2017, a total of 240 subjects at 12 sites were randomized to either the Restore group (n = 120) or the SeQuent Please group (n = 120). Nine-month in-segment late loss was 0.38 ± 0.50 mm with Restore versus 0.35 ± 0.47 mm with SeQuent Please; the 1-sided 97.5% upper confidence limit of the difference was 0.17 mm, achieving noninferiority of Restore compared with SeQuent Please (p for noninferiority = 0.02). Both DCBs had similar 1-year rates of target lesion failure (13.3% vs. 12.6%; p = 0.87). ConclusionsIn this head-to-head randomized trial, the Restore DCB was noninferior to the SeQuent Please DCB for the primary endpoint of 9-month in-segment late loss. (Compare the Efficacy and Safety of RESTORE DEB and SeQuent Please in Chinese Patient With Coronary In-stent Restenosis; NCT02944890)

Discussion on Administrative Innovation of Medical Device in China and U.S

This article refreshes the innovative review approach of medical device in China at first. It proposes reference through presenting a series of existing review and approval of innovative medical device in U.S. as well as new tools and methods for supporting scientific review.