Medihub Prostate is a semi-automatic image processing software designed for analyzing prostate MR images. It uses AI to outline the prostate region semi-automatically and supports radiologists and urologists in reviewing MR data. The software requires user editing and confirmation, enhancing the accuracy of prostate volume measurements and analysis, aiding clinical decision-making without replacing the expert's judgment.
Intended Use
MEDIHUB PROSTATE is an image processing software package that performs outlining, processing, viewing, and editing of prostate MR images to support study review and analysis with computed modules. It semi-automatically outlines the prostate, requires user editing and confirmation, and provides multiparametric MRI viewing and combined image visualization.
Technology
The device is a semi-automatic image processing software for multiparametric prostate MRI analysis accessed via a web browser. It employs an AI-based deep learning algorithm to outline prostate volume semi-automatically, with user interaction required to edit and approve contours. Other measurements and annotations are manual. The software combines multiple MRI sequences into single images and outputs structured reporting including PI-RADS scores.
Performance
Performance testing included multi-site datasets from Korea, US, and an open dataset with Siemens 3T Vida and Skyra MRI machines. The prostate segmentation algorithm was clinically validated by comparison to ground truth from expert radiologists, achieving a mean Dice coefficient of 0.928 and Hausdorff distance of 2.171, exceeding the performance acceptance criterion of 0.894. Reader studies demonstrated improved segmentation accuracy with software assistance. Testing confirms safety and effectiveness equivalence to predicate device Quantib Prostate.
Predicate Devices
No predicate devices specified
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