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The GMK® Total Knee System 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. .

The tibial augments are to be attached to the tibial baseplate with both the fixing cylinders and bone cement.

The modification to the original Medacta GMK® (Global Medacta Knee) Total Knee System is a line extension to include the GMK® Revision femoral components (STD and PS), extension stems with offset adaptors, distal and posterior femoral wedges and tibial wedges.

GMK® Revision femoral components are based on the design of the GMK® Primary femoral components in the original 510(k) submission K090988. The GMK® Revision differs from GMK® Primary by an internal box that allows attachment of the extension stem and the femoral pegs are replaced by two threaded holes to attach femoral wedges.

GMK® Revision femoral components are available in two versions, standard and posterior stabilized femurs, left and right from size 1 to 6. The femoral posterior wedges include sizes 1- 6 with a thickness of 5mm and 10mm while the femoral distal wedges are available in the same size range (1- 6), in thicknesses of 4mm, 8mm and 12mm. Distal and posterior wedge screws are offered in 4mm, 8mm, and 12mm. GMK® Revision femoral components work with the same Tibial baseplates, UC tibial inserts, posterior stabilized tibial inserts and patellas cleared under the original GMK® Total Knee System, K090988.

The offset adaptors are available in 3mm and the associated extension stems are offered in diameters of 11mm, 16mm, 19mm and 20mm with each being 65mm, 105mm or 150mm in length. The tibial wedges are available in size 1- 6 at a thickness of 5mm or 10mm.

The provided text describes a 510(k) submission for a medical device, the GMK® Total Knee System - Revision. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness. Therefore, the "study that proves the device meets the acceptance criteria" in this context refers to the performance testing conducted to show that the revised device is as safe and effective as its predicate.

Here's an analysis of the provided information:

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 for Test Set: Not explicitly stated as a number of devices. The document mentions "worst case component size and option/design" for mechanical testing, implying a limited, targeted selection of components for physical evaluation. This is typical for mechanical testing of orthopedic implants, where physical samples are manufactured and subjected to rigorous testing.
• Data Provenance: The testing was conducted by or on behalf of MEDACTA International SA, based in Castel San Pietro, Switzerland. The tests were performed to FDA guidance and international standards (e.g., ASTM, ISO), which are globally recognized. The data is prospective in the sense that the tests were performed specifically for this 510(k) submission.

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)

• This information is not applicable to this type of submission. For a 510(k) for an orthopedic implant, "ground truth" is established through engineering and material science principles, based on recognized standards (ASTM, ISO) and laboratory testing. There are no clinical images or diagnostic cases requiring expert review for ground truth in this submission.

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

• This information is not applicable as the evaluation of this device involves mechanical and material testing against predefined engineering standards, not human interpretation of clinical data. The "adjudication" is met by the test results falling within the accepted parameters specified by the standards.

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

• This information is not applicable as this is a physical orthopedic implant, not a diagnostic imaging device or an AI-powered system designed to assist human readers.

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

• This information is not applicable as this is a physical orthopedic implant, not a software algorithm.

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

• The "ground truth" for this device's performance testing is established through recognized engineering standards (ASTM, ISO) and the physical properties of the materials and design. The acceptance criteria for mechanical integrity (e.g., surviving 10 million cycles under physiological loads, acceptable torsional forces) are derived from these established standards and real-world physiological demands on implants.

8. The sample size for the training set

• This information is not applicable. There is no "training set" in the context of mechanical performance testing for a physical orthopedic implant. This term is relevant for AI/machine learning models or statistical models that learn from data.

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

• This information is not applicable, as there is no training set for this type of device submission.

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