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The ADVANCE A-CLASS Tibial Insert is indicated for use with the Advance Total Knee system in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with the following conditions:

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.

The ADVANCE A-CLASS Insert is for single use. The Advance Total Knee System porous components are for use without bone cement. The Advance Total Knee System non-porous components are for use with bone cement.

The design features of the ADVANCE® A-CLASS® Tibial Insert are summarized below:

• Articulating Surface: Medial Pivot rotation
• Lock Detail: Perimeter capture with central dove tail .
• Size Range: Sizes 1-6, thicknesses of 10mm-25mm .
• Material: Cross-Linked GRU1020 UHMWPE ●

This document is a 510(k) summary for the ADVANCE® A-CLASS® Tibial Insert, classifying it as substantially equivalent to a predicate device. It defines the device's technical specifications and intended use but does not contain information about acceptance criteria or a study demonstrating the device meets those criteria, as typically found in a clinical trial report or a performance validation study.

Therefore, most of the requested information cannot be extracted from the provided text. The document is primarily a regulatory submission for premarket notification.

Here's a breakdown of what can and cannot be answered from the provided text:

1. A table of acceptance criteria and the reported device performance:

• Cannot be provided. This document does not specify any performance acceptance criteria or report on device performance based on such criteria. It focuses on demonstrating substantial equivalence to a predicate device based on design features and material.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Cannot be provided. This document does not describe any test set or study data in this context.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• Cannot be provided. This document does not describe any ground truth establishment by experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Cannot be provided. This document does not describe any adjudication method.

5. 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:

• Cannot be provided. This device is a medical implant (tibial insert), not an AI-assisted diagnostic tool. Therefore, an MRMC study related to human reader improvement with AI is not applicable.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

• Cannot be provided. This is a physical device, not an algorithm, so this question is not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• Cannot be provided. No ground truth establishment is described.

8. The sample size for the training set:

• Cannot be provided. There is no mention of a training set for an algorithm described in this document.

9. How the ground truth for the training set was established:

• Cannot be provided. No training set or ground truth for it is mentioned.

Summary of available information:

The document is a 510(k) summary for a medical device (tibial insert). Its primary purpose is to demonstrate substantial equivalence to existing devices, not to present a study proving performance against acceptance criteria in the manner described in the prompt. Substantial equivalence in this context is based on comparing design features and materials to those of predicate devices already on the market.

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