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Its engine uses pattern recognition and artificial neural networks trained on biopsy-proven cancers, benign lesions and normal cases. In a retrospective reader study, 18 radiologists from practices in nine US states read 185 cases with and without the software. The cases came from women with dense breasts screened at 13 US sites in 2009 and 2010, and 52 had cancer. FDA reviewers report that reading time fell from 215 to 144 seconds per case, a 71-second or 33% reduction. The average AUC was 0.7353 with the software and 0.7493 without it, which met the non-inferiority margin. FDA approved QVCAD on 9 November 2016. The reviewers write that faster reading may raise patient throughput and help wider use of breast ultrasound. They also warn that readers may rely too much on the absence of marks.","replication":{"produced_by":["Radiologists completed eight hours of hands-on training with the software.","Readers reviewed the original ultrasound images alongside the marked projection image."],"must_hold":["The images come from the somo•v Automated Breast Ultrasound System.","The woman has dense breasts and a screening mammogram rated BI-RADS 1 or 2."],"echoes":[]}}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["account","replication"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"}},"summary":{"total":91,"addressed":91,"known":29,"reviewed":2,"reviewed_complete":2,"reviewed_partial":0,"record_mapped":27,"review_not_assessed":62,"not_assessed":0,"complete":false,"by_state":{"value_present":29,"not_reported":0,"unresolved":62,"not_assessed":0,"not_applicable":0,"withheld":0,"source_unavailable":0}}},"presentation_version":"24b5bc93096eb3c06267d092c297b25d348f8238e424d7fd9c27e5910d664684"}