This study aims to enhance breast cancer detection accuracy through an AI-driven ultrasound tool, Vis-BUS, developed by Barreleye Inc., Seoul, South Korea. Vis-BUS incorporates Lesion Detection AI (LD-AI) and Lesion Analysis AI (LA-AI), along with a Cancer Probability Score (CPS), to differentiate between benign and malignant breast lesions. A retrospective analysis was conducted on 258 breast ultrasound examinations to evaluate Vis-BUS's performance. The primary methods included the application of LD-AI and LA-AI to b-mode ultrasound images and the generation of CPS for each lesion. Diagnostic accuracy was assessed using metrics such as the Area Under the Receiver Operating Characteristic curve (AUROC) and the Area Under the Precision-Recall curve (AUPRC). The study found that Vis-BUS achieved high diagnostic accuracy, with an AUROC of 0.964 and an AUPRC of 0.967, indicating its effectiveness in distinguishing between benign and malignant lesions. Logistic regression analysis identified that 'Fatty' lesion density had an extremely high odds ratio (OR) of 27.7781, suggesting potential convergence issues. The 'Unknown' density category had an OR of 0.3185, indicating a lower likelihood of correct classification. Medium and large lesion sizes were associated with lower likelihoods of correct classification, with ORs of 0.7891 and 0.8014, respectively. The presence of microcalcifications showed an OR of 1.360. Among Breast Imaging-Reporting and Data System categories, category C5 had a significantly higher OR of 10.173, reflecting a higher likelihood of correct classification. Vis-BUS significantly improves diagnostic precision and supports clinical decision-making in breast cancer screening. However, further refinement is needed in areas like lesion density characterization and calcification detection to optimize its performance.
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