Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical application

The Stealth AXiS Surgical System is a computer-assisted surgery platform that tracks surgical instrument position and displays it on preoperative or intraoperative patient images to guide surgeons during spine procedures. It supports both optical and electromagnetic localization and can function as a robotic-assisted system when combined with the Stealth AXiS Autopilot. The Spine clinical application helps guide surgeons during interbody device placement, pedicle screw placement, and iliosacral screw placement in adult and skeletally mature pediatric patients.

The subject device uses optical (infrared) and hybrid (optical + electromagnetic) tracking with 7-axis motorized robotic arm positioning, compared to the primary predicate's 6-axis positioning and optical-only tracking. Both achieve mean positional accuracy ≤2.0 mm and trajectory error ≤2 degrees. The subject supports CT, fluoroscopy, and X-ray imaging with multiple registration features including automatic 3D image registration and segmental tracking, similar to predicates. Both manual and automatic spine segmentation are supported, along with AI-enabled automatic planning and segmentation features.

AAMI ES60601-1:2005/AMD1:2012 and AAMI ES60601-1:2005/AMD2:2021 for electrical emissions and immunity; IEC 60601-1-2:2014+ A1:2020 for electromagnetic compatibility, safety, and essential performance. Platform and software verification and validation testing, hardware testing, summative usability validation in simulated clinical environment, and electrical, mechanical, and thermal safety testing were performed.

The Stealth AXiS Surgical System is substantially equivalent to the Mazor X System and StealthStation S8 predicates because it performs the same stereotactic surgical guidance function with comparable indications for use, accuracy specifications, imaging modalities, and registration features. Although the subject device includes a 7-axis robotic arm (vs. 6-axis predicate) and hybrid tracking capability (vs. optical-only), these represent enhancements rather than fundamental functional differences. Nonclinical testing demonstrated equivalent accuracy performance, and retrospective clinical literature review on predicate systems supports safety and effectiveness for the intended patient populations.