ARVIS Surgical Navigation System

The ARVIS Surgical Navigation System is a computer-controlled surgical navigation system that assists surgeons in positioning and aligning orthopedic implants during knee and hip arthroplasty procedures. It uses preoperative imaging to intraoperatively track surgical tools and anatomical structures, displaying augmented reality visualization and measurements on a head-mounted display to guide implant placement.

The subject device is identical to the predicate in its navigation platform, electronic hardware, intended use, operating principle, main system components, materials, and tracking technology. The sole technological addition is the capability to remotely activate graphical user interface buttons and checkboxes from a tablet device, providing a third input method alongside existing gaze and voice control.

Not stated in this summary.

The device is substantially equivalent because it maintains identical intended use, operating principle, main system components, materials, and navigation tracking technology and accuracy as the predicate. The only modification—tablet-based GUI activation—is an alternative input method that does not change the core safety and effectiveness profile. Software verification and validation testing confirmed the added capability functions properly without affecting the fundamental performance and safety characteristics that were already established for the predicate device.