(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 text describes a 510(k) premarket notification for a medical device: "Proven Modular Posterior Stabilized Femoral Component" (part of the "StelKast Proven Cemented, Semi-Constrained Total Knee System"). This document is a letter from the FDA stating that the device is substantially equivalent to legally marketed predicate devices.
The document does not contain information about acceptance criteria, device performance, studies, sample sizes, ground truth establishment, or expert qualifications.
The 510(k) pathway, particularly for devices like this knee component, primarily relies on demonstrating substantial equivalence to a predicate device already on the market. This typically involves performance testing (e.g., mechanical, wear, fatigue) to show that the new device performs as safely and effectively as the predicate, rather than broad clinical studies with human participants that establish de novo performance criteria or compare AI-assisted human performance.
Therefore, I cannot fulfill your request for the specific details about acceptance criteria, study design, and ground truth as these are not present in the provided FDA letter.
§ 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.