DrAid™ for Liver Segmentation
VinBrain Joint Stock CompanyDrAid™ for Liver Segmentation is a web-based AI software that assists healthcare professionals in analyzing liver images from CT scans. It generates semi-automated liver segmentation and allows physicians to manually refine these segmentations and identify lesions, aiding in evaluation and treatment planning without providing direct diagnosis.
Intended Use
DrAid™ for Liver Segmentation is a web-based software, non-invasive image analysis application designed for the visualization, evaluation, and reporting of liver and physician identified lesions using multiphase images (with slice thickness <= 3.0mm) of patients aged and older than 22 years old obtained from CT scanners. It enables professionals to review and analyze multiphase volume datasets of the liver, providing semi-automated liver segmentation editable by physicians and tools for manual segmentation of lesions. The software outputs liver volume, lesion volume, and lesion dimensions to aid evaluation and treatment planning.
Technology
DrAid™ for Liver Segmentation is a web-based software application that processes multiphase CT DICOM images using an AI algorithm for semi-automated liver segmentation, combined with manual editing capabilities. It provides a DICOM processing module, liver segmentation viewer, measurement algorithms, and reporting tools. It operates on standard hospital/clinic workstations to assist physicians and technicians.
Performance
Performance testing included validation on 450 contrast-enhanced CT scans from US medical institutions, showing a mean Dice score of 0.9649 and HD95 of 1.7061 for liver segmentation, meeting or exceeding acceptance criteria. Liver volume measurement error was within 3% mean normalized volume error. Testing used ground truth annotations from 3 US board-certified radiologists and validated device robustness across various scanner types and patient subgroups.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
5/31/2024
6 months - 2
FDA Approval
12/6/2024
Other devices from VinBrain Joint Stock Company
- DrAid for Radiology v12022 • 510K
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