xvision Spine system
Augmedics, Ltd.The xvision Spine system is an image-guided navigation device that helps surgeons accurately place screws and navigate during spine surgeries. Using a headset, it overlays imaging data—such as CT or fluoroscopy—onto the surgeon's field of view, improving precision and potentially increasing patient safety during complex spinal procedures.
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, where reference to rigid anatomical structures such as the spine or pelvis can be identified relative to a patient’s fluoroscopic or CT imagery.
Technology
The xvision Spine System is an image-guided navigation system with a headset, dedicated software, single use passive reflective markers, and reusable components. It employs wireless optical tracking technology, displaying real-time tracked instrument locations relative to the patient’s images with a near-eye augmented reality headset.
Performance
The device was tested for software verification and validation, electrical safety, EMC, SAR compliance, shipping, cleaning/disinfection, mechanical reliability, positional and registration accuracy, and underwent user preference/ergonomics studies. All tests demonstrated that the system performed according to specifications and as intended.
Predicate Devices
No predicate devices specified
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