Evaluation of Digital Breast Tomosynthesis as Replacement of Full-Field Digital Mammography Using an In Silico Imaging Trial

Key Points Question Can in silico imaging trials play a role in the evaluation of new medical imaging systems? Findings This diagnostic study used computer-simulated imaging of 2986 synthetic image–based virtual patients to compare digital mammography and digital breast tomosynthesis and found an improved lesion detection performance favoring tomosynthesis for all breast sizes and lesion types. The increased performance for tomosynthesis was consistent with results from a comparative trial using human patients and radiologists. Meaning The study’s findings suggest that in silico imaging trials and imaging system computer simulation tools can in some cases be considered viable sources of evidence for the regulatory evaluation of imaging devices.