SpineAR SNAP (SyncAR Spine)

SpineAR SNAP is a software-based augmented reality (AR) surgical guidance system for spinal stereotaxic surgery, specifically pedicle screw placement in the lumbar and thoracic spine. It transforms 2D medical images into 3D interactive scenes for preoperative planning on-screen or via VR headsets, and streams real-time surgical guidance overlays to AR headsets (HoloLens2 and Magic Leap 1) during intraoperative navigation, always used alongside 2D stereotaxic information displayed on a monitor.

The subject device has identical technological characteristics and principle of operation as the predicate; no design changes were made. The only modification involves expanded indications for use: HoloLens2 AR headset support was broadened from lumbar-region-only spinal implant procedures to include thoracic-region procedures, matching Magic Leap 1 capabilities already cleared in the predicate.

Not stated in this summary.

Substantial equivalence is established because both devices share identical intended use (preoperative and intraoperative surgical planning for spinal stereotaxic procedures), technological characteristics, and operational principles. The modification required no design changes—only performance validation data demonstrating that HoloLens2 achieves equivalent pedicle screw placement accuracy in thoracic procedures (mean positional error 0.76 mm versus Magic Leap 1's 1.04 mm; both meeting <2.0 mm requirement), confirming the HoloLens2 implementation poses no new safety or effectiveness risks.