Customize
3D-Side SACustomize is a software tool designed to assist physicians in planning shoulder arthroplasties by visualizing, modifying, and validating 3D models generated from CT scans. It helps communicate treatment options, segments CT data, and manages cases and timelines, aiding clinicians in surgical preparation and decision-making.
Intended Use
Customize for shoulder arthroplasty is intended to be used as a software interface to assist in visualization, modification, validation of the planning of shoulder arthroplasty, communication of treatment options, segmentation of CT-scan data, 3D CAD models generation, and managing timeline and cases. It is not intended for spine surgeries or implant and instrument design. It is for adult patients only and not for diagnostic purposes.
Technology
Customize is a single software interface using 3D CAD files generated from multi-slice DICOM CT data. It allows review and modification of 3D objects including an implant library, implant positioning, sizing, and saves treatment plans for use during surgery. It includes a unique distance map feature estimating distances between objects.
Performance
Non-clinical performance data including software verification, validation, segmentation validation, repeatability/reproducibility studies, and 3D model accuracy testing supports safety and effectiveness, demonstrating substantial equivalence to the predicate device.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
12/3/2021
3 months - 2
FDA Approval
3/16/2022
Other devices from 3D-Side SA
- Customize2022 • 510K
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