Mazor X System / Mazor X Stealth Edition

The Mazor X Stealth Edition is a robotic-assisted surgical system for precise positioning of surgical instruments and spinal implants during general spinal surgery. It combines robotic trajectory guidance with optical navigation and can process 2D fluoroscopic images into 3D volumetric images. It is used in open, minimally invasive, or percutaneous spinal procedures in hospital operating rooms.

The modified Mazor X removes the X-Eye camera and replaces its intra-operative positioning function with a 'Drag AP DOT' feature. It adds three software enhancements: 2D Automatic Measurements using machine-learning algorithms for spinopelvic landmark detection, Plan Assist for automated pedicle screw position suggestions, and Automatic Registration with O-arm capability. Hardware and core robotic/navigation mechanisms remain substantially identical to the predicate K230064.

IEC 62304 (medical device software development), IEC 60601-1 (electrical safety), IEC 60601-1-2 (electromagnetic compatibility), IEC 60825-1 (laser safety), FDA Guidance on General Principles of Software Validation (January 11, 2002), and performance benchmarking for accuracy (<1.5 mm system accuracy, <2 mm navigation positional error).

The modified device maintains identical indications for use, product codes, regulatory classification, target anatomy, and operating environment as the predicate. The X-Eye camera removal and Drag AP DOT replacement are hardware modifications with negligible impact on system dimensions and weight. The three new AI-enabled software features (2D Automatic Measurements, Plan Assist, Automatic Registration) enhance planning and registration workflows but do not change the system's fundamental mechanism of action, accuracy specifications, or safety profile. Performance testing demonstrates the new features meet clinical acceptance criteria and do not raise new safety or effectiveness issues. Therefore, the modified system is substantially equivalent to K230064.