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The UC-PLUS Solution Unicondylar Knee System is intended for use in unicompartmental degenerative arthritis, local osteonecrosis of the femoral condyle, light to medium unicompartmental destruction of the knee joint due to idiopathic and post-traumatic degenerative arthritis, traumatic unicompartmental bone and/or cartilage lesions. For use with bone cement only.

The UC-PLUS Solution Unicondylar Knee System consists of a femoral component and a tibial component. The femoral component is made of a cobalt chrome cast alloy and is 4mm thick. Symetrical components can be used with right or left. The cement pockets are continuous for a minimal cement thickness of 1mm. The femoral component is available in 5 sizes. The tibial component has a flat articulating surface which provides more flexibility. The all-poly tibial component is made of UHMWPE. A cemented metal back tibial component is also available, made of cobalt chrome cast alloy and a UHMWPE insert. Both tibial components come in 5 sizes, 4 thicknesses each. All materials conform to ASTM standards.

The provided text describes a 510(k) summary for the UC-PLUS Solution Unicondylar Knee System, a knee joint prosthesis. It outlines the characteristics, indications for use, and contraindications. However, the document specifically states that "Biomechanical Testing has been provided" for performance data, but it does NOT actually detail the acceptance criteria or the results of a study to prove the device meets specific performance criteria.

Therefore, I cannot provide the requested table and detailed information about a study proving the device meets acceptance criteria because that information is not present in the provided text.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance.
• Sample sizes for a test set, data provenance, or the number of experts for ground truth.
• Adjudication methods.
• Information about a multi-reader multi-case (MRMC) comparative effectiveness study or a standalone algorithm-only study.
• The type of ground truth used.
• Sample size for the training set or how its ground truth was established.

The document primarily focuses on the description of the device and its regulatory clearance based on substantial equivalence to a predicate device (Sigma Uni-Compartmental Knee System P.F.C.). The mention of "Biomechanical Testing has been provided" indicates that such testing was submitted to the FDA, but the results and acceptance criteria are not included in this summary.

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