Quantib Prostate
Quantib BVQuantib Prostate is an AI-powered image post-processing software designed to assist medical professionals in analyzing prostate MRI scans. It provides tools for visualization, semi-automatic segmentation of prostate anatomy and lesions, volume computations, and PI-RADS scoring support to facilitate the interpretation of prostate MR studies, aiding clinical decision-making.
Intended Use
Quantib Prostate is image post-processing software that provides the user with processing, visualization, and editing of prostate MRI images. The software facilitates the analysis and study review of MR data sets and provides additional mathematical and/or statistical analysis. The resulting analysis can be displayed in a variety of formats, including images overlaid onto source MRI images. It supports registered multiparametric-MRI viewing, semi-automatic segmentation of anatomical structures, volume computations, and PI-RADS scoring in a structured workflow. It is intended for use by trained medical professionals to assist in prostate MR study interpretation but not as a sole basis for diagnosis.
Technology
Quantib Prostate functions as an extension to the Quantib AI Node platform, performing automatic segmentation of prostate and sub-regions (central gland, peripheral zone, urethra) on multiparametric MRI scans, multi-parametric MRI image registration, lesion segmentation, and PI-RADS scoring. It includes user interaction modules for manual editing and approval of segmentations and result export modules producing reports and DICOM outputs. The device uses AI algorithms for segmentation and image registration adapted to prostate MRI analysis.
Performance
The device underwent bench testing comparing automatic sub-region segmentation to ground truth with Dice overlap and Mean Surface Distance metrics. Clinical qualitative evaluations by radiologists using a 5-point Likert scale rated sub-region segmentations and ROI localization as high quality. Bench and clinical testing demonstrated the device's safety and effectiveness comparable to its predicate.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
4/15/2022
28 days - 2
FDA Approval
5/13/2022
Other devices from Quantib BV
- Quantib Prostate2023 • 510K
- Quantib ND2022 • 510K
- Quantib Prostate2020 • 510K
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