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The GENFlex2 Total Knee System is intended for:
· Total knee replacement due to osteoardis, theumatoid arthritis, and/or post-traumatic degenerative problems.
· Revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.
The device is intended for cemented use only.

The purpose of this Special 510(k) is to add the Ultra-Congruent CR Tibial Insert to the GENFlex2 Total Knee System. The Ultra-Congruent CR Tibial Insert is a component within a cemented total knee joint replacement system comprised of modular components with varying sizes available for each component. The articulating geometry of the Ultra-Congruent CR Tibial Insert provides for increased stability relative to the predicate CR insert. The inserts are manufactured from EXp Vitamin E Polyethylene and Conventional Polyethylene.

The provided text describes a 510(k) premarket notification for a medical device, specifically a knee replacement system component. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving that the device meets specific acceptance criteria related to its performance in a clinical or diagnostic setting. Therefore, most of the information requested in the prompt, such as an acceptance criteria table, sample sizes for test sets, expert consensus, MRMC studies, standalone performance, and ground truth establishment for AI/diagnostic devices, is not applicable to this submission type.

The document discusses bench testing to demonstrate the physical performance of the device (A/P constraint testing and contact area analyses), but these are engineering verification tests, not clinical performance studies with human subjects or expert readers establishing ground truth for diagnostic accuracy.

Here's a breakdown of the relevant information provided in the given text, and why other parts of your request cannot be fulfilled:

Acceptance Criteria and Device Performance (Not directly addressing the prompt for diagnostic/AI devices):

• A/P constraint testing: Performed on the modified GENFlex2 Ultra-Congruent CR Tibial Inserts and compared to results for the predicate inserts. The statement says, "All results demonstrate that the modified device performs similarly to the predicate device."
• Contact area analyses: Performed on the modified and predicate devices. Again, "All results demonstrate that the modified device performs similarly to the predicate device."
• Limulus Amebocyte Lysate (LAL) testing: Performed to establish that the device meets pyrogen limit specifications.

Table of Acceptance Criteria and Reported Device Performance:

• The document states that the "modified geometry of the Ultra-Congruent CR Tibial Insert meets the pre-determined acceptance criteria for the verification activities." However, it does not provide a table with specific numerical acceptance criteria or the exact reported performance values from these engineering tests. It only states that the performance was "similar" to the predicate device and met pyrogen limits.

Applicable Information from the Text:

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

   • Acceptance Criteria: "meets the pre-determined acceptance criteria for the verification activities" (no specific numerical criteria provided). "meets pyrogen limit specifications."
   • Reported Device Performance:
     • A/P constraint testing: "All results demonstrate that the modified device performs similarly to the predicate device."
     • Contact area analyses: "All results demonstrate that the modified device performs similarly to the predicate device."
     • LAL testing: Confirmed device meets pyrogen limit specifications.

2. Sample sized used for the test set and the data provenance: Not applicable in the context of clinical/diagnostic AI device testing. The tests mentioned are engineering bench tests, not involving human data or a "test set" in the diagnostic sense.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is not a study requiring expert readers or ground truth establishment for diagnostic accuracy.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

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 is not an AI/diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/diagnostic device.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. The "ground truth" here is the engineering specifications and performance of the predicate device, for which the new device demonstrated "similarity."

8. The sample size for the training set: Not applicable. There is no training set mentioned as this is not an AI/machine learning device.

9. How the ground truth for the training set was established: Not applicable.

In summary, the provided text describes a 510(k) submission for a physical medical device (knee implant component) that demonstrates substantial equivalence through engineering bench testing and material compatibility, rather than a study on a diagnostic AI device requiring the detailed "acceptance criteria" and "ground truth" information for accuracy performance.

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