MySegmenter (v2.0.0)
MySegmenter Technologies Inc.MySegmenter (v2.0.0) is a medical imaging software that converts CT and MRI scans into 3D anatomical models for surgical planning and educational use, specifically in orthopedic and craniomaxillofacial cases. It helps clinicians visualize and prepare for surgeries by creating accurate, patient-specific 3D models, though it is not intended for use in the operating room.
Intended Use
MySegmenter (v2.0.0) is a medical images segmentation tool that converts CT and MRI scans into 3D anatomical models intended for surgical planning or educational purposes but not for use in the operating room. It must be used under supervision of qualified medical professionals and is for pre-operational planning in orthopedic and craniomaxillofacial cases.
Technology
MySegmenter processes medical images by analyzing pixel luminance to segment specific anatomical areas using manual and semi-automatic tools. It supports DICOM image imports, navigates through images, edits segments with various effects, and produces editable 3D STL mesh files for surgical planning and educational models.
Performance
Verification and validation testing including unit, functional, integration, system, user acceptance, software performance and API testing confirmed proper software compliance. Accuracy studies comparing outputs against predicate device using DICE, Jaccard similarity coefficients, and Hausdorff distance showed segmentation accuracy between 90-98% and surface deviations below 0.6 mm. 3D printed models had geometric differences below 1 mm compared to predicate device, supporting safety and effectiveness equivalence.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/3/2024
7 months - 2
FDA Approval
4/16/2025
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