(81 days)
The indications for use of this femoral insert are noninflammatory degenerative joint disease including osteoarthritis or traumatic arthritis, avascular necrosis of the femoral condyle, post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus or flexion deformities, rheumatoid arthritis, treatment of fractures that are unmanageable using other techniques.
This femoral component is available in six sizes, to fit into, and articulate with, the existing Foundation® Knee System. The CoCr alloy (ASTM F75) component is plasma sprayed with commercially pure titanium to provide a roughened surface to enhance fixation. The femoral component has two smooth pegs to provide medial/lateral stability.
The provided document is a 510(k) premarket notification for a medical device (femoral component for a knee prosthesis). It does not contain information about acceptance criteria, device performance studies, or details relevant to artificial intelligence (AI) or algorithm-based performance evaluation.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them, nor can I provide information on sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details.
The document focuses on:
- Device identification: Trade name, common name, classification.
- Material and design description: CoCr alloy, plasma-sprayed titanium, two pegs.
- Indications for use: Lists various degenerative and inflammatory joint diseases, deformities, and fractures.
- Predicate device comparison: Mentions similar features, design, and indications to existing knee systems.
To answer your prompt, I would need a different type of document, such as a clinical study report, a regulatory submission for an AI/ML medical device, or a performance evaluation plan.
§ 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.