xvision Spine System
Augmedics Ltd.The xvision Spine System by Augmedics Ltd. is an augmented reality-based surgical navigation system designed to aid surgeons in precisely locating anatomical structures during open or percutaneous spine procedures. It combines preoperative CT or intraoperative X-ray imaging with a headset that overlays virtual 3D navigation information directly onto the patient's anatomy in real-time, enhancing surgical accuracy and safety for spine operations such as pedicle screw placement and other spinal trajectories.
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.
Technology
The system utilizes augmented reality via a near-eye see-through display, wireless optical tracking with a headset, single-use reflective markers, and software incorporating a deep learning-based spine segmentation algorithm for vertebral identification. It supports intraoperative registration using either 3D scanning or a novel 2D-3D registration method aligning preoperative CT with intraoperative X-rays.
Performance
Performance was validated via phantom and cadaver studies demonstrating system accuracy with mean positional errors of 2.0 mm and trajectory errors of 2°, verification of segmentation accuracy via Dice coefficient metrics, and compliance with IEC 62304 software validation and extensive human factors testing.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
5/24/2024
4 months - 2
FDA Approval
10/16/2024
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