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The Evolis®/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 condvle.
• 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 a line extension to include the GMK® Revision Hybrid Liners. The GMK® Revision Hybrid Liners work with tibial baseplates from the GMK® Total Knee System, femoral components from the Evolis Total Knee System, and an extension stem, offset connector, and tibial wedges from the GMK® Total Knee System -Revision, which are optional for patient specific cases. The GMK Revision Hybrid Liners provide the surgeon with an additional option. The GMK® Revision Hybrid Liners are offered as both Ultracongruent (UC) Fixed and Posterior Stabilized (PS) Fixed in six sizes with five thicknesses from 10 mm to 20 mm. The GMK® Revision Hybrid Liners are attached to the GMK® tibial baseplates of the same size from the GMK® Total Knee System and articulate with the existing Evolis femoral component. The device is used primarily during an Evolis Revision surgery where the Evolis tibial baseplate is revised with a GMK tibial baseplate and the existing Evolis femoral component stays intact. The GMK Revision Hybrid Liners can also be used if a surgeon desires to couple a GMK tibial baseplate with an Evolis femoral component during a primary surgery. GMK Revision ultracongruent hybrid liners can be used only with standard Evolis femoral components and fixed GMK tibial baseplates. GMK Revision posterior-stabilized hybrid liners can be used only with posterior-stabilized Evolis femoral components and fixed GMK tibial baseplates.

The provided text describes a 510(k) premarket notification for the GMK® Total Knee System - GMK Revision Hybrid Liners. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a clinical study with detailed acceptance criteria and performance data as might be found in a De Novo submission or a PMA.

Therefore, much of the requested information regarding acceptance criteria, specific study designs, sample sizes for test and training sets, expert involvement, and ground truth establishment is not available in the provided document. The document explicitly states: "No performance standards applicable to this device have been adopted under Section 514 of the Food, Drug and Cosmetic Act."

However, I can extract information about the performance testing that was conducted to demonstrate substantial equivalence.

Here's a breakdown of the available and unavailable information based on your request:

Acceptance Criteria and Device Performance (Based on available information)

Study Details (Based on available information)

1. Sample size used for the test set and the data provenance:

   • Sample Size: The document states, "The testing was conducted on the worst case component size and option/design based on engineering analysis." This implies a limited sample size, likely focusing on specific configurations deemed most challenging, rather than a broad statistical sample of all possible configurations. No specific number is given.
   • Data Provenance: Not explicitly stated, but as a medical device manufacturer based in Switzerland (Medacta International SA) with a US contact, the testing would likely have been conducted in-house or by a contracted lab, adhering to international standards for medical device testing. It is a prospective test in the sense that the testing was performed specifically for this submission.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not Applicable. This type of information (expert consensus, ground truth establishment) is typically relevant for studies involving qualitative assessments or diagnostic accuracy (e.g., image analysis, clinical decision-making). This submission is for mechanical components, and the "ground truth" is established through physical and mechanical testing protocols against engineering specifications and predicate device performance.

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

   • Not Applicable. Adjudication methods are typically used in clinical trials or studies where human interpretation of data is involved. Here, the "adjudication" is the assessment of whether the mechanical tests met pre-defined engineering acceptance criteria.

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:

   • No. This is not an AI-assisted device and no MRMC study was conducted.

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

   • No. This is a mechanical implant device, not an algorithm.

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

   • Engineering Specifications and Predicate Device Performance: The "ground truth" for mechanical performance of the GMK® Revision Hybrid Liners was established by:
     • Written protocols with pre-defined acceptance criteria based on standards and FDA guidance.
     • Comparison to the performance of the predicate device systems (GMK® Total Knee System and Evolis Total Knee System).
     • Risk analysis.
   • This is a technical ground truth, not a clinical or pathological one.

7. The sample size for the training set:

   • Not Applicable. This is a mechanical device, not an AI/machine learning algorithm, so there is no "training set."

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

   • Not Applicable. As above, no training set.

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