Segment 3DPrint
Medviso ABSegment 3DPrint is a medical software developed by Medviso AB that helps clinicians review and segment images from medical scanners to generate detailed 3D models. These models assist doctors with visualization, measuring, and treatment planning, particularly in orthopaedic, maxillofacial, and cardiovascular fields. The software also supports creating physical 3D printed replicas from these models, enhancing clinical workflows and patient care.
Intended Use
Segment 3DPrint is a software for review and segmentation of images from a medical scanner as well as of medical 3D models. It is intended to generate 3D models for diagnostic purposes in orthopaedic, maxillofacial, and cardiovascular applications, for visualization, measuring, and treatment planning. Output can be used to fabricate physical replicas through additive manufacturing. Intended for use by medically trained professionals with clinical judgement.
Technology
Software for visualization and segmentation of medical images and 3D models providing semi-automatic and manual segmentation with different algorithms than predicate device. Operates on standard Windows PC with graphical user interface, imports images from various sources, creates digital 3D models for clinical use, and supports additive manufacturing output for physical model fabrication.
Performance
Performance testing includes software verification and validation per FDA guidance, automated and manual testing including beta site use. Clinical and bench studies assessed accuracy of 3D models (<1 mm error) including additive manufacturing replicas. AI bone segmentation trained and validated on diverse datasets showed high agreement (Dice ~0.96) with expert reference segmentations. No adverse events reported, demonstrating safety and effectiveness comparable to predicate device.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
6/24/2021
10 months - 2
FDA Approval
5/6/2022
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