Mixed Reality Spine Navigation

Mixed Reality Spine Navigation is software that runs on Magic Leap 2 MedTech glasses and works with Brainlab's Spine & Trauma Navigation system. It displays 2D navigation screens and a 3D virtual model of patient anatomy with stereotactic information about tracked surgical instruments during pedicle screw placement procedures. The virtual display is meant to supplement, not replace, the stereotactic information shown on the main navigation platform.

The subject device uses the Magic Leap 2 MedTech mixed reality headset (an optical see-through head-mounted display) instead of a traditional monitor display. It employs encrypted Wi-Fi data transfer from the Image Guided Surgery platform to the headset, gesture controls for user interaction (versus the predicate's touch screen), and Mixed Reality Toolkit GUI technology (versus HTML5). Navigation accuracy remains identical at ≤2 mm positional error and ≤2° angular error, and it uses the same optical tracking localization as the predicate.

IEC 60601-1 Edition 3.2 (basic safety), IEC 60601-1-2 Edition 4.1 (EMC), ISO 10993-1:2018 (biocompatibility), IEC 63145-20-10:2019, IEC 63145-20-20:2019, and IEC 63145-22-10:2020 (eyewear display optical properties). Software testing followed FDA guidance on Device Software Functions at Enhanced Documentation level.

The device performs the same fundamental function as the predicate—displaying navigation information to support surgeon guidance during spine surgery with identical navigation accuracy specifications. While it adds a new display modality (mixed reality headset) and different user interface technology, the clinical purpose, intended use environment (operating room), localization technique, and performance characteristics are equivalent. The predicate comparison demonstrates that differences in hardware (Magic Leap 2 MedTech versus prior display) and interface method (gesture control versus touch) do not alter the essential therapeutic function or safety profile.