Rapid Surgical Plan (RSP-SW-001)

Navbit Rapid Surgical Plan is software for pre-operative planning in primary total hip arthroplasty. It assists surgeons in selecting and positioning hip replacement components by analyzing X-ray images and providing a recommended cup orientation target based on each patient's spinopelvic mobility to reduce implant impingement risk.

The device is a standalone web-based software application (versus the predicate's iPad app) that accepts X-ray images via DICOM upload and performs measurements using annotation tools for points, lines, and circles. Key difference: analysis is conducted by trained planning technicians rather than surgeons, and it requires two additional X-ray views (weightbearing AP and flexed-seated) compared to the predicate's two views.

IEC 62304 (Medical Device Software—Software Life Cycle Processes); FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.

Both devices provide cup orientation recommendations based on spinopelvic mobility assessment from functional X-rays using similar algorithms and measurement tools on PNG images. Although the subject device uses planning technicians instead of surgeons and adds imaging views, user validation demonstrated technicians achieve equivalent accuracy to surgeons. The web-based interface and additional measurement capabilities (linear measurements via circles) do not create new safety or effectiveness concerns because verification and validation testing confirmed the device meets design requirements and performs safely in its intended clinical environment.