xvision Spine system

The xvision Spine System is an image-guided navigation system designed to assist surgeons in accurately placing pedicle screws during open or percutaneous spine surgery. It uses wireless optical tracking to display the location of surgical instruments relative to patient imaging on a transparent near-eye-display headset, allowing surgeons to view both the patient and navigation data simultaneously. The system is indicated for various spinal procedures including posterior pedicle screw placement, iliosacral screw placement, and lateral trajectories for sacro-iliac joint access.

The modified system maintains identical technological characteristics to the predicate: wireless optical tracking with 6 DOF, single infrared camera positioned 0.5m above tracked objects, Perspective N-point tracking algorithm, augmented reality near-eye see-through display with 32.5° vertical × 18° horizontal field of view, 1280×720 pixel resolution per eye, system accuracy requirement of 2.0mm mean 3D positional error and 2° mean trajectory error, and support for multiple C-ARM imaging systems. Minor modifications include updates to the C-ARM Ring adaptor, a new Patient Marker Extender component for improved reflector visibility, and software enhancements for GUI, cybersecurity, and HIPAA compliance.

ISO 14971 (Medical Devices - Application of Risk Management to Medical Devices) was used for risk analysis. Device design controls per 21 CFR 820.30 were applied. The document references compliance with sterilization, cleaning, and transportation standards but does not cite specific consensus standards (ASTM, IEC, etc.) by number.

The modified system is substantially equivalent because it maintains identical intended use, indications for use, and core technological principles as the predicate device (K241481). Although hardware modifications were made to the C-ARM Ring adaptor and a new Patient Marker Extender was introduced, these changes do not alter the registration workflow or fundamental technology—they only enhance reliability and ease of use. Performance testing verified that modified components meet the same acceptance criteria as cleared components, and system accuracy (positional and angular) during 2D/3D registration was validated using identical methods and criteria as the predicate. Therefore, the minor design changes present no new safety or efficacy questions.