Rapid Surgical Plan (RSP-SW-001)
Navbit Pty LtdNavbit Rapid Surgical Plan is a software tool designed to assist surgeons in planning primary total hip replacement surgeries. It analyzes X-ray images of a patient's hip and spine to provide recommendations on the placement of hip replacement components, aiming to reduce complications. The software helps surgeons by offering data-driven guidance based on patient-specific anatomy and mobility.
Intended Use
Navbit Rapid Surgical Plan is intended for pre-operative planning for primary total hip arthroplasty. Rapid Surgical Plan is intended to be used as a tool to assist the surgeon in the selection and positioning of components in primary total hip arthroplasty. Rapid Surgical Plan is indicated for individuals undergoing primary hip surgery.
Technology
Navbit Rapid Surgical Plan is a standalone software medical device that uses uploaded DICOM-format X-ray images converted to PNG for landmarking and measurements by trained surgical planning technicians. It provides a baseline acetabular cup orientation recommendation to reduce implant impingement based on spinopelvic mobility, using algorithms informed by clinical literature. The device is a web application designed to be used in clinical settings by surgeons.
Performance
The device underwent extensive non-clinical testing including software verification per IEC 62304, clinical measurement accuracy validation against surgeon-labeled ground truth, device measurement accuracy tests (linear, angular, and ratio accuracy), and usability engineering validation. No human clinical trials were needed as non-clinical testing demonstrated safety and effectiveness.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/7/2024
28 days - 2
FDA Approval
12/5/2024
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