(625 days)
Indications include the relief of pain and restoration of motion due to non-inflammatory degenerative joint diseases, rheumatoid arthritis, deformities of the knee and revisions of previously failed knee replacements. The device is intended for use with bone cement.
The Freeman/Samuelson Knee is a Co-Cr-Mo femoral component. a Co-Cr-Mo backed polyethylene tibial component and a polyethylene patellar component designed to replace a damaged or disease knee joint.
The system features interchangablity between all sizes of components. The femoral component is available with of without a central stem and offers the option of using finned polyethylene pegs or splined titanium pegs for added fixation of the femoral component. The tibial component has a central stem and attached splined pegs. The polyethylene bearing surface is molded to the metal tibial base plate. The all polyethylene patella component has a finned fixation peg. the patella is contoured to provided greater surface contact than traditional domed patellar components.
I am sorry, but the provided text primarily focuses on describing the "Freeman/Samuelson Total Knee System," its components, indications for use, and potential risks. It also lists devices considered substantially equivalent.
There is no information in the text about:
- Acceptance criteria for a study.
- Performance metrics of the device against any criteria.
- Details of any study (sample sizes, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) that proves the device meets specific acceptance criteria.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input.
§ 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.