Performance Evaluation of Genius AI Detection Software v2.0

This technical report provides a performance evaluation of the Genius AI Detection Software version 2.0, comparing it to the previously released version. The evaluation focuses on the improvements made in the cancer detection algorithm for 3D breast tomosynthesis images. The report outlines the study design, which utilized fROC analysis and key metrics to assess the software's performance using a sequestered dataset of Hologic's 3D breast tomosynthesis exams. The findings indicate that Genius AI Detection Software 2.0 demonstrates improved specificity, with a significant reduction in false positive marks. Additionally, the report details the performance of the CC-MLO Correlation software, which accurately correlates marks between standard screening views. The results confirm that the new version meets or exceeds the performance of its predecessor across various metrics, including sensitivity and specificity, while also providing additional information for radiologists. Overall, the report presents a comprehensive analysis of the software's advancements and their implications for breast cancer detection.