Preview Shoulder
Genesis Software InnovationsPreview Shoulder is a pre-operative planning software that helps orthopedic surgeons develop shoulder surgery plans by processing patient CT scans. The software reconstructs 3D models of the shoulder anatomy, allowing surgeons to digitally place implants and generate detailed surgical planning reports, thus aiding surgical preparation without providing diagnostic decisions.
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 software application that receives and processes DICOM CT images of patients, reconstructs 3D bone models, and enables digital placement of implant models for surgical planning. It includes 3D digital representations of implants and allows generation of a surgical planning report. It uses AI algorithms for reconstructing 3D bone models from image data.
Performance
Software verification and validation testing were performed, including automated and manual testing to ensure accurate 3D reconstructions and surgical coordinate generation. Measurement capabilities were validated against a benchmark CT rendering tool (Osirix MD) using anonymized patient CT images. Clinical testing was deemed unnecessary to demonstrate substantial equivalence with the predicate device.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
2/25/2021
1 month - 2
FDA Approval
4/21/2021
Other devices from Genesis Software Innovations
- Preview Shoulder2024 • 510K
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