ARVIS� Shoulder
Insight Medical Systems, Inc.ARVIS® Shoulder is a computer-assisted surgical navigation system designed to help surgeons precisely position and align implants during total shoulder arthroplasty. It uses preoperative CT scans processed with AI algorithms for automatic image segmentation and anatomical landmark identification, providing real-time measurements during surgery to guide instrument placement and implant positioning, thereby enhancing surgical accuracy and outcomes.
Intended Use
ARVIS® Shoulder is indicated for assisting the surgeon in the positioning and alignment of implants relative to reference alignment axes and landmarks in stereotactic orthopedic surgery. The system aids the surgeon in making intraoperative measurements and locating anatomical structures of the shoulder joint based on the patient's preoperative imaging. ARVIS® Shoulder is indicated for total shoulder arthroplasty using the Enovis AltiVate implant system.
Technology
ARVIS® Shoulder integrates software, electronic hardware, and surgical instruments to intraoperatively track tools and locate anatomical structures using preoperative CT imaging. It employs AI-based automatic image segmentation and landmarking algorithms trained on a dataset of 300 patient CT scans. The system is image-based, relying on CT reconstructions for surgical navigation, and uses hardware mounted on the surgeon's head and waist to provide real-time navigation feedback.
Performance
Performance testing included positional accuracy testing, accuracy after mechanical disturbances, benchtop and cadaveric accuracy testing, and software verification and validation. The AI algorithms for image segmentation and landmarking were validated on a separate test set of 60 patient CT scans and showed high accuracy metrics that met predefined acceptance criteria. Clinical testing was not required. These results demonstrate that the device is safe, effective, and substantially equivalent to the predicate.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
1/9/2024
3 months - 2
FDA Approval
4/29/2024
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