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The Symmetric Unicompanimental Knee System is for Cemented Use Only and is indicated for restroing efther compartment of a knee that has been damaged by rheumatoid arthritis, post-traumatic arthritis, osteoarthritis, failed osteotomies or hemiarthroplasties.

The Symmetric Unicompartmental Knee System is intended for the resurfacing of one side of the knee joint. The system consists of metallic femoral and tibial components and a polyethylene tibial insert. The FEMORAL COMPONENT is symmetrically designed eliminating the need for left/right orientations. The femoral component is manufactured from cast cobalt chromium/molybdenum (CoCrMo) and features a central peg, which aids in stabilization. A central strut is provided for rotational stability and added strength. The femoral component will be available in five sizes (1-5) and will be porous coated with Commercial Pure Titanium (CPTi). The TIBIAL COMPONENT is a symmetrically designed component, eliminating the need for left/right orientations. The tibial component is manufactured from wrought titanium alloy (Ti-6Al-4V). The tibial tray features a central fin and four pegs on the underside aiding in rotational stabilization. A screw hole is in the center of the tibial tray for optional screw fixation. The tibial tray is designed with locking features permitting the UHMWPE tibial insert to be snapped into place. The tibial tray has 5 sizes (1 - 5) and is porous coated with Commercial Pure Titanium (CPT)). The TIBIAL INSERT is also a symmetrically designed component manufactured from Ultra-High Molecular Weight Polyethylene (ASTM F648). The inserts' articulating geometry is semi-constrained and is captured in the tibial tray by the mating capture features. The insert is available in 5 thicknesses (6, 8, 10, 12, and 14mm) and 5 sizes (1 - 5).

The provided text describes the "Symmetric Unicompartmental Knee System" and its 510(k) summary for FDA clearance. However, it does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria related to AI or diagnostic accuracy.

The document is a regulatory submission for a medical device (a knee implant) and focuses on describing the device, its components, and its substantial equivalence to previously marketed devices based on design and materials, rather than a diagnostic performance study.

Therefore, I cannot provide the requested information in the format of the table or answer the specific questions about acceptance criteria, sample sizes, ground truth, expert opinions, or MRMC studies because this type of data is not present in the provided text.

The closest relevant information, though not directly addressing your prompt, is:

• "Push-out strength test results on the tibial tray insert are comparable to other legally marketed devices." This implies a mechanical performance test was conducted, and its results were deemed equivalent to competitor devices, but no specifics on acceptance criteria or the study itself are detailed.

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