QP-Prostate® CAD
Quibim S.L.QP-Prostate® CAD is an artificial intelligence-based software that helps doctors detect and identify suspicious lesions in the prostate gland using bi-parametric prostate MRI. It highlights areas of concern on the images to assist physicians during their interpretation but should be used alongside other clinical information. It seamlessly integrates with existing DICOM imaging systems and PACS, improving the diagnostic workflow for prostate cancer detection.
Intended Use
QP-Prostate® CAD is a Computed Aided Detection and Diagnosis (CADe/CADx) image processing software that automatically detects and identifies suspected lesions in the prostate gland based on bi-parametric prostate MRI. It is intended to be used as a concurrent read by physicians with proper training as an aid for interpreting prostate MRI studies.
Technology
QP-Prostate® CAD is AI-based software using neural networks and machine learning trained with pathology-verified biopsy data. It processes T2W and DWI MRI sequences, outputs overlays on source images in DICOM format, and integrates with PACS. The algorithm differs from the predicate device which uses random forest, but verification and validation support safety and effectiveness.
Performance
The device was validated on a diverse, multi-center US dataset of 228 cases independent from training data, showing lesion-level AUC-ROC of 0.732, sensitivity of 0.677 at high suspicion, and improved reader AUC from 0.849 to 0.868 with device aid. Performance was consistent across demographic and hardware subgroups.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/6/2024
6 months - 2
FDA Approval
3/18/2025
Other devices from Quibim S.L.
- QP-Brain�2023 • 510K
- QUIBIM Precision Prostate (qp-Prostate)2021 • 510K
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