Mixed Reality Spine Navigation
Brainlab AGMixed Reality Spine Navigation is an accessory software used with Brainlab's Spine & Trauma Navigation platform. It employs a mixed reality headset (Magic Leap 2 Medtech) to provide surgeons with 2D and 3D floating visualizations of the patient's spine anatomy and tracked surgical instruments during pedicle screw placement surgery, enhancing intraoperative navigation and precision.
Intended Use
Accessory to Spine & Trauma Navigation software displaying 2D navigation screens and 3D virtual representations with stereotactic information of tracked instruments on a mixed reality headset to support spine surgery navigation.
Technology
Software runs on Magic Leap 2 Medtech mixed reality glasses communicating over encrypted Wi-Fi with Brainlab Image Guided Surgery platforms. Displays stereoscopic 2D and 3D visualizations with optical tracking of instruments, using gesture control for surgeon interaction.
Performance
Extensive software verification and validation, hardware safety and biocompatibility testing, usability testing in simulated operating room, and network performance benchmarking were performed. No clinical testing was required.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
8/28/2024
8 months - 2
FDA Approval
5/16/2025
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