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.

Standardizing the measurement of dose reduction is a problem of broad interest to the CT community and to public health. A necessary step in the process is the objective assessment of CT image quality, for which various task-based methods may be suitable. This paper attempts to consolidate recent literature that is relevant to the development and implementation of task-based methods for the assessment of CT IR image quality.