(24 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.
Additional Component to the Proven Cemented, Semi-Constrained Total Knee System and Cruciate Retaining Femoral Component and Tibial Insert
The provided text is a 510(k) clearance letter from the FDA for a medical device (StelKast Company's "Proven Cemented Knee and Cruciate Retaining System").
This document does not contain any information about acceptance criteria, device performance from a study, sample sizes, data provenance, expert qualifications, ground truth, or details about comparative effectiveness studies (MRMC or standalone).
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, because this information is not present in the provided text. The letter only states that the device is "substantially equivalent" to predicate devices, which is a regulatory determination, not a statement of specific performance metrics or a detailed study report.
§ 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.