Precision AI Surgical Planning System (PAI-SPS)

The Precision AI Surgical Planning System (PAI-SPS) is a patient-specific medical device that assists surgeons in planning and performing shoulder joint replacement surgery. It consists of software that creates a 3D model of the patient's shoulder from CT scans, allows the surgeon to virtually position implant components, and optionally generates patient-specific surgical guides and models using 3D printing to guide component positioning during total or reverse shoulder arthroplasty.

The subject device's software has identical technological characteristics to the primary predicate (K243955), with the addition of an optional anatomical shape reconstruction feature—a capability already present in the predicate device SurgiCase Shoulder Planner. The hardware is substantially equivalent in intended use, design, functionality, operating principles, materials, and performance characteristics.

Software verification and validation following FDA Guidance on 'Premarket Submissions for Device Software Functions' and 'General Principles of Software Validation.' Usability validation following FDA Guidance on 'Applying Human Factors and Usability Engineering to Medical Devices.'

The PAI-SPS is substantially equivalent because it has identical intended use and indications for use as the primary predicate (K243955), the software differences do not affect safety or effectiveness, and the hardware is substantially equivalent in all relevant characteristics. Clinical testing was not required given the substantial equivalence demonstrated through design and performance comparisons.