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The GMK knee prosthesis is designed for cemented use in total knee arthroplasty, if there is evidence of sufficient sound bone to seat and support the components. This knee replacement system is indicated in the following cases: · Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, rheumatoid arthritis or polyarthritis. · Avascular necrosis of femoral condyle. · Post traumatic loss of joint configuration. · Primary implantation failure. Tibial augments are to be attached to the tibial baseplate with both the fixing cylinders and bone cement. In case a semi-constrained liner is used, an extension stem must be implanted both on the tibial and on the femoral components.

This modification to the original Medacta GMK® (Global Medacta Knee) Total Knee System is intended to include the GMK Resurfacing Patella Size 4.

The provided text describes a 510(k) premarket notification for a medical device, the GMK Resurfacing Patella Size 4. This document is a regulatory submission to the FDA, demonstrating substantial equivalence to previously cleared devices. It does not contain information about an AI-powered device or a study involving human readers or extensive clinical trials as would be standard for AI/ML device submissions.

Therefore, many of the requested items related to AI/ML device performance and testing (such as sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable to this particular document.

Here's a breakdown of the available information relevant to the device and its performance, as presented in the document:

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

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

• Sample Size: The document does not specify a numerical sample size for testing in terms of individual devices or clinical cases. It mentions that "testing was conducted on the worst case component size and option/design based on engineering analysis." This implies a limited, focused mechanical testing approach on representative worst-case prototypes rather than a large statistical sample of units or a clinical study.
• Data Provenance: Not applicable in the context of device design verification that relies on mechanical testing. The testing is described as an internal design verification process, not a clinical study with patient data.

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)

• Not applicable. This is not a study assessing diagnostic accuracy or image interpretation where expert ground truth would be established. The "ground truth" here is based on engineering principles, established standards, FDA guidance, and comparison to predicate devices, verified through mechanical testing.

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

• Not applicable. No expert adjudication process is described as it is an engineering verification against pre-defined criteria and standards, not a clinical trial with human interpretation of outcomes.

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

• Not applicable. This document is for a medical implant (knee resurfacing patella) and does not involve AI or human "readers" in the diagnostic sense.

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

• Not applicable. This device is a physical implant, not an algorithm.

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

• The "ground truth" for this device's performance evaluation is based on:
  • Engineering principles and analysis: To identify worst-case scenarios.
  • Established mechanical testing standards: Not explicitly named but stated as being part of the process.
  • FDA guidance: Guiding the development of pre-defined acceptance criteria.
  • Performance characteristics of legally marketed predicate devices: Used for comparison to demonstrate substantial equivalence.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device that requires a training set.

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

• Not applicable. This is not an AI/ML device.

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