CRRS-4 Pivotal Somo•v™ ABUS ROC Reader Observer Study

The Clinical Retrospective Reader Study is an observational case-controlled, multi-reader multi-case Receiver Operating Characteristic (ROC) study involving approximately 16 Interpreting Physicians (Readers) and approximately 200 breast screening cases which will be reviewed and of those, 164 breast screening cases will be included in the primary data analysis. All primary data analysis cases will consist of screening mammogram and Automated Breast Ultrasound image readings from the same asymptomatic females with \>50% parenchymal density for whom the screening mammogram was assigned a BI-RADS Assessment Category 1 (negative) or 2 (normal with benign findings). The Readers will review a total of 200 cases: the Non-Cancer Case Set, the Cancer Case Set, and additional Control and Supplemental Case Sets. These cases will be randomized during the reading session so each Reader will review the entire Case Set in a unique order. The primary Receiver Operating Characteristic analysis will be performed on the Readers' Likelihood of Malignancy (LOM) ratings from their initial review of the screening mammogram alone and their final review of the screening mammogram and Automated Breast Ultrasound for the Non-Cancer Case Set and Cancer Case Set.