aprevo� Digital Segmentation
Carlsmed, Inc.aprevo® Digital Segmentation is a software tool designed for trained medical personnel to process medical images of the spine, specifically the lumbar area. It uses AI algorithms to automatically segment the spine from DICOM images and generates a 3D model, aiding in clinical planning or design tasks related to spine anatomy.
Intended Use
The software is intended to be used by trained, medically knowledgeable design personnel to perform digital image segmentation of the spine, primarily lumbar anatomy. The device inputs DICOM images and outputs a 3D model of the spine.
Technology
This software imports DICOM medical images, performs preprocessing to filter soft tissue and identify spine structures, and uses an AI-based algorithm to automatically segment the spine and generate a 3D model as the output. It allows users to import, visualize, segment, check, correct segmentations, and create digital 3D models.
Performance
The software was validated with independent training and validation datasets representing diverse populations and equipment. Performance metrics included an intersection over union (IOU) score exceeding 80% for segmentation, vertebral body labeling accuracy over 90%, and sensitivity and specificity each above 80%.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
7/3/2023
4 months - 2
FDA Approval
11/3/2023
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