Multicenter, Multivendor Validation of an FDA-approved Algorithm for Mammography Triage

Objective Artificial intelligence (AI)-based triage algorithms may improve cancer detection and expedite radiologist workflow. To this end, the performance of a commercial AI-based triage algorithm on screening mammograms was evaluated across breast densities and lesion types. Methods This retrospective, IRB-exempt, multicenter, multivendor study examined 1255 screening 4-view mammograms (400 positive and 855 negative studies). Images were anonymized by providing institutions and analyzed by a commercially available AI algorithm (cmTriage, CureMetrix, La Jolla, CA) that performed retrospective triage at the study level by flagging exams as "suspicious" or not. Sensitivities and specificities with confidence intervals were derived from area under the curve (AUC) calculations. Results The algorithm demonstrated an AUC of 0.95 (95% CI: 0.94-0.96) for case identification. Area under the curve held across densities (0.95) and lesion types (masses: 0.94 [95% CI: 0.92-0.96] or microcalcifications: 0.97 [95% CI: 0.96-0.99]). The algorithm has a default sensitivity of 93% (95% CI: 95.6%-90.5%) with specificity of 76.3% (95% CI: 79.2%-73.4%). To evaluate real-world performance, a sensitivity of 86.9% (95% CI: 83.6%-90.2%) was tested, as observed for practicing radiologists by the Breast Cancer Surveillance Consortium (BCSC) study. The resulting specificity was 88.5% (95% CI: 86.4%-90.7%), similar to the BCSC specificity of 88.9%, indicating performance comparable to real-world results. Conclusion When tested for lesion detection, an AI-based triage software can perform at the level of practicing radiologists. Drawing attention to suspicious exams may improve reader specificity and help streamline radiologist workflow, enabling faster turnaround times and improving care.