TumorSight Risk
SimBioSys, Inc.TumorSight Risk is an AI software tool that helps doctors estimate the chance of breast cancer returning in previously diagnosed patients. It combines MRI images and clinical data to produce risk scores, supporting physicians in making personalized decisions about future care.
Intended Use
TumorSight Risk is intended for use in adult women with hormone receptor positive (HR+) and human epidermal growth factor receptor 2 negative (HER2-), lymph node negative (N0) or positive (N1), Stage I-IIIA breast cancer to inform a physician in prognostic risk-based decisions in conjunction with other relevant clinicopathological factors.
Technology
TumorSight Risk is a software-only device using AI algorithms to analyze both DCE-MRI images and clinical/pathological data to provide prognostic risk estimates for breast cancer recurrence. It integrates image processing, segmentation, and machine learning to output risk scores and categories, leveraging output from the previously cleared TumorSight Viz device.
Performance
The TumorSight Risk device underwent analytical precision testing with simulated MRI noise (n=120 images) showing high consistency (% agreement ≥98.9% across manufacturers). Human factors validation confirmed safe, effective use by physicians and support staff. A retrospective clinical study (n=2,129 patients) demonstrated that the device reliably stratifies breast cancer recurrence risk, with high negative predictive value at 5 and 10 years. The validation population was broadly representative of the intended use cohort, confirming clinical and analytical performance.
Predicate Devices
No predicate devices specified
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