Description of use

Intended Use: Detects foci that are suspicious for breast cancer metastasis on WSI from lymph node specimens. If concerning morphology is detected, it indicates the foci suspicious for cancer. It is the responsibility of a qualified pathologist to employ appropriate procedures to assure the quality of the images.

Performance: Standalone performance was evaluated with 685 WSI from slides prepared in diverse laboratories, including cancer & benign cases. Cancer cases were enriched for challenging tumors (less than 0.5mm linear extent). Overall sensitivity and specificity were measured as 98% and 85%, respectively. Overall micrometastasis sensitivity was measured as 97.7% and small metastasis sensitivity was 98.9%.