xvision Spine system
Augmedics Ltd.The xvision Spine system by Augmedics Ltd. is an advanced surgical navigation system that helps surgeons precisely locate anatomical structures in the spine during open or percutaneous procedures. By integrating near-eye augmented reality displays with fluoroscopic and CT images, it enables real-time visualization of tracked surgical instruments overlaid on patient anatomy, improving accuracy for procedures such as pedicle screw and iliosacral screw placement. This technology enhances surgical precision and safety, aiding clinicians in complex spine surgeries.
Intended Use
The xvision Spine System, with xvision Spine System Software, is intended as an aid for precisely locating anatomical structures in either open or percutaneous spine procedures such as pedicle screw placement and iliosacral screw placement, using reference to fluoroscopic or CT imagery.
Technology
The system uses wireless optical tracking technology with reflective markers and a near-eye transparent augmented reality headset to project the position of surgical instruments relative to patient anatomy captured by fluoroscopic or CT scans. It includes software with deep-learning based spine segmentation and enhanced GUI for 2D-3D registration, and hardware updates to improve marker visibility and reliability.
Performance
Verification and validation included risk analysis, bench testing with coordinate measuring machine and calculations, proving mechanical stability of new parts and system accuracy matching predicate device. Software updates underwent validation per FDA guidance and internal lifecycle procedures, ensuring unchanged safety and effectiveness.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
1/28/2025
1 month - 2
FDA Approval
3/13/2025
Other devices from Augmedics Ltd.
- xvision Spine System2024 • 510K
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