Fig. 4: Overview of the study design.

Set 1: As part of the standard single screening procedure, mammograms were read by radiologists without AI-CAD, and then read with AI-CAD assistance. A radiologist specializing in breast imaging (i.e., BR) was defined as someone with more than 10 years of experience at a university hospital and expertise in breast imaging. Even when AI-CAD assistance was provided after the radiologist’s initial interpretation without AI-CAD, the final decision to recall a patient for further diagnostic evaluation was based on the radiologist’s comprehensive decision. Set 2: As a secondary and exploratory objective, a separate simulation study was conducted involving general radiologists (i.e., GR), who did not specialize in breast imaging, to compare their performance with and without AI-CAD. Standalone AI: For exploratory purposes, results from standalone AI-CAD were also evaluated. AI results were considered positive when the abnormality score exceeded a predefined cutoff value of 10. The study compared the diagnostic performance of radiologists, with and without AI-CAD assistance, in identifying screening-detected cancers confirmed pathologically within a 1-year follow-up period.