OptiVu™ Shoulder

OptiVu Shoulder is a stereotaxic surgical navigation system that uses augmented reality (AR) with a head-mounted display and mixed reality trackers to aid surgeons in locating anatomical structures, performing humerus resection, and aligning implants during total or reverse shoulder arthroplasty procedures. It works with Zimmer Biomet shoulder implant systems and preoperative planning data from the Zimmer CAS Signature ONE System, and the HMD must be used alongside traditional surgical methods, not as a sole guidance tool.

OptiVu Shoulder shares the same stereotaxic surgical navigation principle as predicate devices, using optical tracking with infrared cameras and trackers to register and monitor anatomical landmarks and surgical instruments in real-time. Like the predicates, it uses preoperative CT-based planning data and provides intraoperative guidance via software algorithms; key differences noted (such as AR head-mounted display versus traditional screen displays in some predicates) do not raise new safety or efficacy questions.

Not stated in this summary. The document references "established standards" for non-clinical testing acceptance criteria but does not cite specific ISO, IEC, ASTM, or other consensus standards by number or title.

OptiVu Shoulder is substantially equivalent because it has identical indications for use (stereotaxic surgery to locate anatomy and align shoulder prostheses), the same fundamental principle of operation (stereotaxic navigation with optical tracking and preoperative planning), and technological characteristics that do not raise new questions regarding safety or effectiveness. Verification and validation activities including performance tests, usability engineering, and cadaveric lab validation demonstrated the system is at least as safe and effective as the predicate devices (Pixee Medical Knee+, NextAR RSA Platform, and ROSA Shoulder System), with any differences being design variations that maintain the same intended function.