Customize
3D-Side SACustomize is a prescription-use software tool designed to assist clinicians in planning ankle arthroplasty surgeries. It uses CT and X-ray images to generate 3D models and helps visualize and modify surgical treatment plans. The software incorporates AI to segment anatomical structures, improving preoperative planning and communication of treatment options.
Intended Use
Customize for ankle arthroplasty is intended to be used as a software interface to assist in visualization, modification, validation of ankle arthroplasty planning, communication of treatment options, segmentation of CT-scan data, 3D CAD model generation, use of X-ray images to enhance planning, and managing timeline and cases. It is for adult patients only and not for diagnostic purposes.
Technology
Customize uses multi-slice CT and X-ray images as inputs to generate 3D CAD models for use in ankle arthroplasty planning. It has an implant library for selecting implant models, includes AI-based segmentation using nonadaptive machine learning trained on 126 CT images with human supervision, and allows modification and validation of plans via a single software interface.
Performance
Performance testing included software verification and validation, segmentation validation, repeatability and reproducibility studies of ankle anatomy segmentation, and accuracy testing of 3D model generation. AI segmentation was trained on a dataset representative of the surgical population. These tests demonstrate substantial equivalence and safety and effectiveness comparable to the predicate device.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
5/17/2022
2 months - 2
FDA Approval
8/3/2022
Other devices from 3D-Side SA
- Customize2022 • 510K
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