ARVIS® Shoulder
Kico Knee Innovation Company Pty LtdThe ARVIS® Shoulder is an AI-powered computer navigation system designed for shoulder replacement surgery. It helps surgeons accurately position implants by using preoperative CT imaging and provides augmented reality visual guidance during the procedure, enhancing surgical precision and patient 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. It is intended to be used with the head mounted ARVIS® Eyepiece display for augmented reality visualization and information to help with total shoulder arthroplasty.
Technology
The device comprises software, electronic hardware, and surgical instruments. It uses CT scan-based preoperative planning with AI-based automatic image segmentation and landmarking algorithms trained on 300 CT scans. The system includes a head-mounted ARVIS® Eyepiece for augmented reality visualization and a belt pack housing the computer module running the ARVIS® Shoulder software. It tracks patient and instrument positions intraoperatively for navigation and implant positioning.
Performance
Performance testing included software verification and validation, with risk analysis demonstrating the device is as safe and effective as the predicate device. Clinical testing was not required to show substantial equivalence.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
12/23/2024
21 days - 2
FDA Approval
1/13/2025
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