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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.

The GMK Narrow Femoral Components are intermediate sizes within the 510(k) cleared size range of the K090988 GMK Total Knee System. GMK Narrow components are designed with the same AP dimension as the correspondent K090988 GMK Total Knee System components (from Size 2 to Size 6) but with a reduced ML dimension of 4 mm. The reduced ML dimension of 4mm corresponds to an "X-1" size of the K090988 GMK Femur in the ML plane. The articular surfaces profile remains the same as the existing femoral components, both for the condyles and the trochlear groove. GMK Narrow Femoral Components are provided in the STD cemented version (to be used with STD and UC fixed tibial inserts) and in the PS cemented version (to be used with PS fixed tibial inserts).

The provided document is a 510(k) summary for the Medacta GMK Narrow Total Knee Prosthesis, which sought to demonstrate substantial equivalence to previously cleared predicate devices. The study conducted to support this submission was a performance testing using finite element method (FEM) analysis.

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: The document does not specify a numerical sample size in the traditional sense of a clinical trial or physical testing with a number of units. Instead, it refers to evaluating the "GMK Narrow Femoral Components" through FEM analysis. This implies the analysis covered the designs of the GMK Narrow components across their intended sizes and configurations.
• Data Provenance: Not applicable in the context of FEM analysis. The data for FEM analysis would be generated internally from the design specifications and material properties of the device and its predicate, rather than from human subjects or existing clinical datasets.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Number of Experts: Not explicitly stated as this was a computational analysis (FEM). Engineering experts, likely with expertise in biomechanics, materials science, and finite element modeling, would have been involved in setting up the simulations and interpreting the results.
• Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The "test set" here refers to the FEM analysis, which generates quantitative data based on engineering principles and computational models. There is no human adjudication of results in this context, but rather an engineering review and comparison to specific criteria.

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

• MRMC Study: No, this was not a multi-reader multi-case comparative effectiveness study. This study involved finite element method (FEM) analysis of a medical device (knee prosthesis), not AI assistance for human readers or interpretation of medical images.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Standalone Performance: Yes, in a manner of speaking within the context of engineering analysis. The FEM analysis is a computational model of the device performance, operating independently of human intervention during the simulation itself. The results of the simulation are then interpreted by engineers. This is a "device-only" performance assessment based on physical principles, not an "algorithm-only" performance in the context of AI.

7. The Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" for this FEM analysis was derived from established engineering principles, material properties (e.g., Cobalt Chromium Molybdenum according to ISO5832-4:1996), and the known performance characteristics of the predicate devices. The goal was to compare the newly designed component's performance (stress distribution, ROM, constraints, mobility, wear behavior) against the established safe performance of the predicate device.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. FEM analysis does not involve a "training set" in the machine learning sense. The models are built based on physical geometry, material properties, and boundary conditions.

9. How the Ground Truth for the Training Set Was Established

• Ground Truth for Training Set Establishment: Not applicable. As there is no training set, there is no ground truth established for one. The "truth" in FEM comes from the physical laws and material behaviors programmed into the model and validated against known real-world behaviors and predicate device performance.

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