ProstatID
ScanMed, LLCProstatID is an AI software tool designed to assist radiologists by analyzing prostate MRI scans to identify and assess suspicious lesions that may indicate prostate cancer. It processes MRI images and provides detection overlays, lesion likelihood scores, 3D renderings, and a summary report to support diagnostic decisions for high-risk screening or diagnostic imaging.
Intended Use
ProstatID is a radiological computer assisted detection (CADe) and diagnostic (CADx) software device used to assist radiologists in detecting, assessing, and characterizing prostate abnormalities, including cancer lesions using prostate MRI data.
Technology
Cloud-based AI software analyzing axial prostate MRI images (T2W, DWI, ADC), applying Deep Learning and Random Forest algorithms trained on biopsy-proven datasets to detect lesions and assess malignancy likelihood, outputting overlays, lesion scores, 3D visualizations, and summary reports delivered via DICOM format.
Performance
Performance was validated via software verification, standalone performance tests with 150 retrospective cases, and a clinical reader study with 9 physicians interpreting 150 cases both with and without the software. Results showed statistically significant improvements in lesion detection and diagnostic accuracy (AUC improved from 0.629 to 0.671).
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/1/2021
10 months - 2
FDA Approval
7/8/2022
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