(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.
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Sponsor: Biomet. Inc. Airport Industrial Park P.O. Box 587 Warsaw, IN 46581-0578
Device: Freeman/Samuelson Total Knee System
K 943025
MAR 1 3 1996
Classification Name: Knee joint patellofemorotibial polymer/metal/polymer semiconstrained cemented prosthesis (CFR 888.3560)
Device Description: 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. 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 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.
Potential Risks: The potential risks associated with this device are the same as with any joint replacement device. These include, but are not limited to:
Reaction to the bone cement Deformity of the joint Cardiovascular disorders Fracture of the cement Implant loosening/migration Tissue growth failure
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Blood vessel damage Soft tissue imbalance Delayed wound healing Metal sensitivity Fracture of the components Nerve damage
Bone fracture Infection Hematoma Dislocation Excessive wear
Substantial Equivalence: In function and overall design, Biomet's Freeman/Samuelson Total Knee System is equivalent to almost all knee components on the market. These stems include:
AGC 2000 Total Knee Prosthesis (Biomet, Inc., Warsaw, IN) Maxim Knee System (Biomet, Inc., Warsaw, IN) Freeman/Samuelson Total Knee (Depuy, Warsaw, IN) Freeman/Samuelson Mark II Press-fit (Protek, Indianapolis, IN) Freeman/Samuelson Mark II Press-fit (Protek, Indianapolis, IN)
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§ 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.