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Artificial intelligence (AI) tools may assist breast screening mammography programs, but limited evidence supports their generalizability to new settings. This retrospective study used a 3-year dataset (April 1, 2016–March 31, 2019) from a U.K. regional screening program. The performance of a commercially available breast screening AI algorithm was assessed with a prespecified and site-specific decision threshold to evaluate whether its performance was transferable to a new clinical site. The dataset consisted of women (aged approximately 50–70 years) who attended routine screening, excluding self-referrals, those with complex physical requirements, those who had undergone a previous mastectomy, and those who underwent screening that had technical recalls or did not have the four standard image views. In total, 55 916 screening attendees (mean age, 60 years ± 6 [SD]) met the inclusion criteria. The prespecified threshold resulted in high recall rates (48.3%, 21 929 of 45 444), which reduced to 13.0% (5896 of 45 444) following threshold calibration, closer to the observed service level (5.0%, 2774 of 55 916). Recall rates also increased approximately threefold following a software upgrade on the mammography equipment, requiring per–software version thresholds. Using software-specific thresholds, the AI algorithm would have recalled 277 of 303 (91.4%) screen-detected cancers and 47 of 138 (34.1%) interval cancers. AI performance and thresholds should be validated for new clinical settings before deployment, while quality assurance systems should monitor AI performance for consistency. Keywords: Breast, Screening, Mammography, Computer Applications–Detection/Diagnosis, Neoplasms-Primary, Technology Assessment Supplemental material is available for this article. © RSNA, 2023 |
