M-SYNTH is organized into a directory structure that indicates the parameters. Code and dataset is released with the Creative Commons 1.0 Universal License We now review the timing required to perform mass insertion and imaging. In Table 2, we review the imaging time required for each breast density. The time varies from 2.84 GPU), we were able to generate the complete dataset in about two weeks.Breast Density Time (min) Fatty 13.463809 Scattered 11.002291 Hetero 3.655613 Dense 2.842028 Table 2: Timing analysis for imaging by breast density. Additional renderings of the breast phantoms generated for the study are shown in Figure 1, demonstrating a high level of detail and anatomical variability within and among models.

To generate evidence regarding the safety and efficacy of artificial intelligence (AI) enabled medical devices, AI models need to be evaluated on a diverse population of patient cases, some of which may not be readily available. We propose an evaluation approach for testing medical imaging AI models that relies on in silico imaging pipelines in which stochastic digital models of human anatomy (in object space) with and without pathology are imaged using a digital replica imaging acquisition system to generate realistic synthetic image datasets. Here, we release M-SYNTH, a dataset of cohorts with four breast fibroglandular density distributions imaged at different exposure levels using Monte Carlo x-ray simulations with the publicly available Virtual Imaging Clinical Trial for Regulatory Evaluation (VICTRE) toolkit. We utilize the synthetic dataset to analyze AI model performance and find that model performance decreases with increasing breast density and increases with higher mass density, as expected. As exposure levels decrease, AI model performance drops with the highest performance achieved at exposure levels lower than the nominal recommended dose for the breast type.

M-SYNTH is organized into a directory structure that indicates the parameters. Code and dataset is released with the Creative Commons 1.0 Universal License We now review the timing required to perform mass insertion and imaging. In Table 2, we review the imaging time required for each breast density. The time varies from 2.84 GPU), we were able to generate the complete dataset in about two weeks.Breast Density Time (min) Fatty 13.463809 Scattered 11.002291 Hetero 3.655613 Dense 2.842028 Table 2: Timing analysis for imaging by breast density. Additional renderings of the breast phantoms generated for the study are shown in Figure 1, demonstrating a high level of detail and anatomical variability within and among models.

To generate evidence regarding the safety and efficacy of artificial intelligence (AI) enabled medical devices, AI models need to be evaluated on a diverse population of patient cases, some of which may not be readily available. We propose an evaluation approach for testing medical imaging AI models that relies on in silico imaging pipelines in which stochastic digital models of human anatomy (in object space) with and without pathology are imaged using a digital replica imaging acquisition system to generate realistic synthetic image datasets. Here, we release M-SYNTH, a dataset of cohorts with four breast fibroglandular density distributions imaged at different exposure levels using Monte Carlo x-ray simulations with the publicly available Virtual Imaging Clinical Trial for Regulatory Evaluation (VICTRE) toolkit. We utilize the synthetic dataset to analyze AI model performance and find that model performance decreases with increasing breast density and increases with higher mass density, as expected. As exposure levels decrease, AI model performance drops with the highest performance achieved at exposure levels lower than the nominal recommended dose for the breast type.