(157 days)
The Orthopilot® 2 Navigation Platform is a system for computer-aided navigation of surgical instruments. Its purpose is to optimally position endoprosthesis in arthroplasty such as the Search Evolution Knee system and the Gem Knee system in the patient. It aids the surgeon in accurately positioning the cutting guides, drills and reamers for total endoprosthesis replacement surgery and provides intraoperative measurements of bone alignment. It indicates optimized angles and positions for implant placement. (Does not include an indication for High Tibial Osteotomy (HTO) module).
Orthopilot® 2 Navigation Platform uses transmitters that are mounted to the patients bones, or are flexible to palpate landmarks and a camera to monitor the spatial location of those transmitters in relation to each other and the medical instruments. These locations are used to locate the centers of rotation of the femur head, ankle, knee. These measurements allow for greater accuracy than mechanical methods of ascertaining implantation sites and positions.
The provided text does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.
The document is a 510(k) premarket notification for the Orthopilot 2 Navigation Platform. It focuses on regulatory compliance, device description, indications for use, and substantial equivalence to previously cleared devices.
Therefore, I cannot fulfill your request for the following information based on the provided text:
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Adjudication method for the test set
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size
- If a standalone performance (i.e. algorithm only without human-in-the-loop performance) was done
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
The document primarily states that the Orthopilot 2 Navigation Platform complies with general safety and electromagnetic compatibility standards (IEC 60601-1, IEC 60601-1-2, CAN/CSA-C22.2 No. 601.1-M90), but these are performance standards for electrical and medical equipment safety, not clinical performance acceptance criteria for the navigation system's accuracy or efficacy in positioning endoprostheses. The FDA's letter also indicates that no applicable performance standards have been promulgated under Section 514 specifically for this device system.
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).