Description of use

Intended Use: For use with digitized H&E stained breast biopsy & excision images. It is the responsibility of a qualified pathologist to employ appropriate procedures to assure the quality of the images obtained and use manual visualization and re-evaluate the product’s results before incorporating in the final diagnosis. Results of the device shall only be considered after a professional pathologist’s initial review of the entire WSI.

Performance: Evaluated on a set of 2,303 breast biopsy & excision slides. Paige Breast has a specificity greater than 61% and sensitivity greater than 97% in identifying slides suspicious for cancer (includes: invasive carcinoma, ductal carcinoma in situ, lobular carcinoma in situ, atypical ductal hyperplasia, atypical lobular hyperplasia).