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The Apollo Knee System Single Lug Patella is designed to articulate with the various tibial and femoral components of the Apollo Total Knee System. The Single Lug Patella is a one piece component manufactured from ultra-high molecular weight polyethylene (UHMWPE, ASTM F648). The design incorporates a large, round, centrally placed, single lug on the back of the component for fixation. A concentric cement groove is incorporated into the stem of the single lug to aid in cement adhesion. A discontinuous dovetail cement groove has also been incorporated into the flat surface on the back of the patella to aid in achieving a bone cement "macro-lock" and to assist in rotational stability of the implant. The component will be available in a 28mm round design as well as 29mmX32mm, 32mmX35mm, and 35mmX38mm elliptically shaped design.
I am sorry, but the provided text does not contain the information required to answer your request. The document is a 510(k) summary for a medical device (Apollo Total Knee System Single Lug Patella) and focuses on product description and substantial equivalence, rather than detailing an acceptance criteria study with the specifics you've requested.
Therefore, I cannot provide:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set or data provenance.
- Number of experts or their qualifications for ground truth.
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- Information on a multi-reader, multi-case (MRMC) comparative effectiveness study or effect size.
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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.