SpineAR SNAP (SyncAR Spine)
Surgical Theater, Inc.SpineAR SNAP is a software device that helps surgeons plan and perform spinal implant surgeries more accurately by transforming traditional 2D medical images into interactive 3D visualizations. It supports pre-operative planning on screens and virtual reality, as well as intra-operative guidance using augmented reality headsets like HoloLens2 and Magic Leap 1. This technology provides enhanced visualization and guidance, improving surgical precision while allowing the surgeon to maintain focus on the surgical field.
Intended Use
Intended for pre-operative surgical planning on-screen and in a virtual environment, and intra-operative surgical planning and visualization on-screen and using AR headset displays with validated navigation systems; indicated for spinal stereotaxic surgery including pedicle screw placement in lumbar and thoracic regions.
Technology
Software-based device that transforms 2D medical images into interactive 3D scenes for surgical planning; interfaces with third-party navigation systems to overlay navigation data on 3D images; supports visualization via HD touch screens, VR headsets for pre-op, and AR headsets for intra-op guidance; provides multiple guidance visualization cues; augmented reality display projects images above patient without obstructing surgical view.
Performance
Performance testing demonstrated that the device using the HoloLens2 AR headset for thoracic spinal implant procedures achieves positional and angular accuracy comparable to the predicate device using Magic Leap 1 headset, with mean positional error below 1 mm and mean angular error below 2 degrees, supporting equivalent accuracy and clinical workflow.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/25/2024
29 days - 2
FDA Approval
12/24/2024
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.