The Caduceus S is an augmented reality-based navigation system designed to assist surgeons in accurately placing pedicle screws during percutaneous spine surgery. It leverages intraoperative CT or 2D/3D C-arm imaging and optical tracking, projecting navigation data directly into a headset worn by the surgeon to improve precision and visualization during procedures involving the thoracic and lumbosacral spine.
Intended Use
Caduceus S is intended as an aid for precisely locating anatomical structures in percutaneous spine procedures, including pedicle screw placement in thoracic and lumbosacral spine using stereotactic surgery referenced to CT or 2D/3D C-arm images.
Technology
The system includes dedicated software, a navigation cart, optical tracking headset, minimally invasive surgical instruments with disposable passive spheres, and universal adaptors. It provides AR-enhanced 2D stereotaxic screens and 3D anatomy models in a near-eye display, projecting instrument position relative to anatomy in real time during surgery.
Performance
Performance testing included verification of headset display parameters (resolution, contrast, latency), electrical safety, EMC testing, sterilization validation, biological evaluation, repeatability and accuracy testing (ASTM F2554), cadaver studies validating screw placement accuracy, and human factors evaluation. All tests demonstrate safety, accuracy, and effective functionality of the system.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
8/1/2024
3 months - 2
FDA Approval
10/30/2024
Ready to Sharpen Your Edge?
Join hundreds of your peers who rely on RadAI Slice. Get the essential weekly briefing that empowers you to navigate the future of radiology.
We respect your privacy. Unsubscribe at any time.