Preview Shoulder
Genesis Software InnovationsPreview Shoulder is a software tool designed to help orthopedic surgeons plan shoulder surgery using 3D models created from CT scans. It allows surgeons to place digital implants within the shoulder anatomy and generate detailed surgical plans to improve surgical outcomes. This software is used as a pre-operative planning aid and is intended for adult patients only, not for diagnostic purposes.
Intended Use
The Preview Shoulder software is intended to be used as a tool for orthopedic surgeons to develop pre-operative shoulder plans based on a patient CT imaging study.
Technology
Preview Shoulder is a standalone 3D total shoulder arthroplasty surgical planning software. It receives and processes DICOM CT images, allows placement of implant digital models on 3D reconstructed bone, and generates surgical planning reports. It includes 3D implant representations and uses image processing to overlap implants on original scans and 3D models.
Performance
Software verification and validation testing demonstrated accurate and repeatable 3D reconstructed bones and surgical coordinates. Measurement capabilities were equivalent to a benchmark CT rendering tool (Osirix MD). Testing used anonymized patient CT images and was validated by surgeons. Clinical testing was not necessary to establish substantial equivalence.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
1/22/2024
2 months - 2
FDA Approval
4/4/2024
Other devices from Genesis Software Innovations
- Preview Shoulder2021 • 510K
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