Artificial foot is an assistive device worn by calf or thigh amputees to enable walking. Orthotic prosthesis including artificial foot are internationally classified as medical devices, but in Korea, they are still classified as assistive devices for the disabled rather than medical devices. All medical devices under the the Ministry of Food and Drug Safety regulation are required to conform to the international standard IEC 62366-1 since 2021. However, prosthetic orthotic products such as artificial foot are not classified as medical devices, so their usability test requirement has not yet been mandated. In this study, four prosthetic orthosis experts formed an advisory committee and applied IEC 62366-1, an international standard for medical device usability evaluation, to develop the usage scenarios for artificial foot products, in indoor and outdoor environments. After selecting 16 tasks in usage environments, we developed guidelines consisting of 52 questionnaires to determine the product's usability, including safety, effectiveness, and satisfaction. Three lower-leg amputees participated in the test application and responded to the survey of the guidelines for a prosthetic foot product while performing 16 tasks. this product received an average score of 3.42 out of 5, and the usability evaluation score was lower on unpaved roads and slippery tiles than on flat surfaces. It is expected that the experience in developing user suitability evaluation guidelines for artificial feet developed in this study can be usefully applied to the development of usability evaluation guidelines for other prosthetic and orthotic products.
Read full abstract