Quantib Prostate
Quantib BVQuantib Prostate is a software tool that helps medical professionals analyze prostate MRI images. It automatically segments the prostate and its subregions, supports visualization with multiparametric MRI, and assists in identifying and editing potential lesions. By streamlining these tasks, it aids radiologists in interpreting prostate MRI studies more efficiently and effectively.
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 includes multiparametric MRI viewing, semi-automatic segmentation of anatomical structures, volume computations, manual editing, and PI-RADS scoring in a structured workflow. It is intended to assist trained medical professionals in interpreting prostate MR studies.
Technology
Quantib Prostate 3.0 includes an automatic processing module for input checks, prostate and sub-region segmentation, mpMRI registration, biparametric image computation, and image cropping. It enables user interaction for segmentation editing, PSA density determination, lesion segmentation and analysis, and automated report and DICOM output generation. The recent update combines prostate and sub-region segmentation into a single improved algorithm trained on over 400 MRI scans.
Performance
Performance testing included bench testing comparing the automatic segmentation with ground truth segmentations using Dice overlap and Mean Surface Distance metrics, showing no issues and comparable performance to the predicate device. Clinical performance involved qualitative assessment by radiologists of the subregion segmentations and ROI localizations using a Likert scale, confirming performance at least as accurate as the predicate device. Safety assessments found no impact from device changes.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
3/21/2023
27 days - 2
FDA Approval
4/17/2023
Other devices from Quantib BV
- Quantib Prostate2022 • 510K
- Quantib ND2022 • 510K
- Quantib Prostate2020 • 510K
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