(29 days)
- Total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems.
- Revision of failed previous reconstructions where sufficient bone stock and soft integrity are present.
- For cemented use only.
Not Found
The provided document is a 510(k) premarket notification letter from the FDA for a medical device (StelKast Proven Modular Tibial Tray). This type of document does not typically contain the detailed technical study information required to answer your specific questions about acceptance criteria and device performance studies.
A 510(k) submission primarily focuses on demonstrating substantial equivalence to a predicate device, as opposed to providing detailed clinical trial results or performance studies with specific statistical metrics, ground truth establishment, or expert reviews as you've outlined.
Therefore, I cannot provide a response with the information you requested based on the input document. The document confirms the FDA's clearance of the device based on substantial equivalence but does not elaborate on the specific performance studies, their methodology, or results.
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.