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Indicated for use in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with the following:

1. noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
2. inflammatory degenerative joint disease including rheumatoid arthritis;
3. correction of functional deformity;
4. revision procedures where other treatments or devices have failed; and
5. treatment of fractures that are unmanageable using other techniques.
   Unicondylar knee system is indicated for patients with unicompartmental joint disease secondary to the above indications with or without valgus, varus, or flexion deformities where all ligaments are intact.
   The ADVANCE® Unicondylar Knee System components are for single use only.
   The ADVANCE® Unicondylar Knee System components are for cemented use only.

The ADVANCE® Unicondylar modular metal-backed tibia is part of the ADVANCE® Unicondylar Knee System that was previously submitted and cleared under 510(k): K012591- ADVANCE® Unicondylar Knee System. Wright Medical Technology is now enhancing the ADVANCE® Unicondylar Knee System by adding a modular titanium metal-backed UHMWPE tibial component. The ADVANCE® Unicondylar Knee System now contains the following components; Co-Cr femoral component, all-poly ultra-high molecular-weight polyethylene (UHMWPE) tibial component and modular titanium metal-backed UHMWPE tibial component.
The ADVANCE® Unicondylar femoral component is identical to the femoral component previously submitted and cleared under ADVANCE® Unicondylar Knee System -510(k): K012591.
The ADVANCE® Unicondylar all-poly tibial component is identical to the all-poly tibial component previously submitted and cleared under ADVANCE® Unicondylar Knee System - 510(k): K012591.
The ADVANCE® Unicondylar modular metal-backed tibial base is manufactured from The ADVANCE® Unicondylar modular tibial insert is titanium (ASTM F136). manufactured from the identical UHMWPE as the ADVANCE® Unicondylar all-poly tibial components (510(k): K012591). The profile and sizing (Sizes 1, 2, 3 & 4) of the ADVANCE® Unicondylar modular metal-backed tibial components are identical to the ADVANCE® Unicondylar all-poly tibial components (510(k): K012591). The cement interface for the ADVANCE® Unicondylar modular metal-backed tibial components consist of a peripheral dovetail and two pegs and is substantially equivalent to the cement interface of the ADVANCE® Unicondylar all-poly tibial components (510(k): K012591). The articulating surface is identical for both the ADVANCE® Unicondylar modular metal-backed tibial insert and the all-poly tibial component (510(k): K012591). The locking mechanism for the ADVANCE® Unicondylar modular metal-backed tibial components is substantially equivalent to the ADVANTIM® Unicondylar modular metalbacked tibial components (510(k): K881779).

This document is a 510(k) Summary of Safety and Effectiveness for the ADVANCE® Unicondylar Knee System, specifically for an enhancement to the system by adding a modular titanium metal-backed UHMWPE tibial component. It is a premarket notification to the FDA, demonstrating "substantial equivalence" to legally marketed predicate devices, rather than a study proving performance against specific acceptance criteria in the traditional sense of a clinical trial for a novel device.

Therefore, many of the requested elements (like sample size for test sets, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, and sample size/ground truth for training sets) are not applicable or available in this type of regulatory submission.

The document demonstrates compliance through "substantial equivalence" to previously cleared devices. This means the new device is as safe and effective as a legally marketed device (the predicate device) that is already on the market.

Here's an analysis based on the provided text, addressing the applicable points:

Acceptance Criteria and Device Performance (in the context of Substantial Equivalence)

Important Note: The "device performance" in this context refers to the demonstration of equivalence to existing devices, not clinical outcomes from a new study against specific performance metrics for a novel technology.

Study Details (as inferable from a 510(k) submission)

1. Sample size used for the test set and the data provenance: Not applicable. A 510(k) submission for substantial equivalence generally does not involve a "test set" or clinical study with patient data in the way a novel device might. The "test set" here would be the design features and materials compared against predicate devices. The data provenance is regulatory history of predicate devices (K012591, K881779) and material performance data which would be referenced but not detailed in this summary.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. "Ground truth" in this context is established by the design specifications and regulatory clearances of the predicate devices themselves, as well as established industry standards for materials and mechanical testing (though specific experts for this are not mentioned in this summary).

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a knee implant, not an AI-assisted diagnostic tool.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithmic device.

6. The type of ground truth used (expert concensus, pathology, outcomes data, etc): The "ground truth" for demonstrating substantial equivalence is the safety and effectiveness profile of the legally marketed predicate devices, as established by their prior FDA clearances and accepted manufacturing standards. This includes material specifications (ASTM F136 for titanium, UHMWPE), design parameters, and functional characteristics.

7. The sample size for the training set: Not applicable. There is no "training set" as this is not a machine learning/AI device.

8. How the ground truth for the training set was established: Not applicable.

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