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Genesis II and Profix Knee Systems are indicated for:

1. Rheumatoid arthritis.
2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity level are compatible with an adequate long-term result.
3. Failed osteotomies, unicompartmental replacement, or total knee replacement.
   Genesis II and Profix Knee Systems are indicated for use only with cement and are single use devices.

The Genesis II Zirconium Femoral Component and the Profix Zirconium Femoral Component are cruciate retaining components indicated for use with existing Genesis II and Profix System Components. Both are manufactured in a variety of sizes in both left and right orientations.

The provided document is a summary of safety and effectiveness for medical devices (femoral components) and describes preclinical testing of their mechanical properties. It does not describe a study involving acceptance criteria related to device performance in terms of diagnostic accuracy or similar metrics, nor does it involve expert assessment, multi-reader studies, or ground truth for diagnostic purposes.

Therefore, I cannot fulfill the request to describe the acceptance criteria and study that proves the device meets them as defined by the input questions because the provided text pertains to mechanical testing of physical orthopedic implants, not an AI/diagnostic device.

However, I can extract information related to the preclinical testing described, reinterpreting "acceptance criteria" as mechanical performance criteria.

Here's an interpretation based on the given document, acknowledging that most questions are not applicable:

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: Not specified in the provided text. The document refers to "testing" which implies a sample of components was tested, but the exact number isn't mentioned.
• Data Provenance: Not specified. This is preclinical testing, likely conducted in a lab environment.

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 mechanical testing of a physical implant, not a diagnostic device requiring expert interpretation for ground truth.

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

Not applicable. This is mechanical testing, not a diagnostic assessment requiring adjudication.

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 mechanical testing of a physical implant and does not involve human readers or AI assistance.

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

Not applicable. This is mechanical testing of a physical implant, not an algorithm.

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

The "ground truth" here would be the physical reality of the material properties and mechanical strength as demonstrated under controlled laboratory conditions, complying with established industry standards and guidance. This is not "ground truth" in the diagnostic sense.

8. The sample size for the training set

Not applicable. This is preclinical mechanical testing, not machine learning model training.

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

Not applicable. This is preclinical mechanical testing, not machine learning model training.

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