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The Versa-Fx Femoral Fixation System may be used for the internal fixation of supracondylar fractures with displaced intra-articular fragments, with verticular extension, and in the patient with multiple lower extremity fractures.

Supracondylar: The Versa-Fx II Femoral Fixation System may be used for the internal fixation of supracondylar fractures with displaced intra-articular fragments, with vertical intra-articular extension, and in the patient with multiple lower extremity fractures.

Proximal Femur: The Versa-Fx II Femoral Fixation System may be used for internal fixation of hip fractures with application to intracapsular and intertrochanteric fractures, arthrodeses, and subtrochanteric fractures with extension into the greater trochanter and the piriformis fossa (Winquist Type III comminuted fracture).

The Free-Lock Femoral Fixation System may be used for internal fixation of hip fractures with application to intracapsular and intertrochanteric fractures, osteotomies, arthrodeses, and subtrochanteric fractures with extension into the greater trochanter and the piriformis fossa (Winquist Type III comminuted fracture).

The subject devices are similar in that they are used for either supracondylar or proximal femur fracture fixation. The systems contain supracondylar tube/plates with angles of 90° and 95° and/or proximal femur tube/plates with angles from 130° to 150°. These systems share the lag and compression screws.

This document is a 510(k) summary for the Zimmer Femoral Fixation Systems, which are medical devices used for internal fixation of certain femoral fractures. It describes changes made to existing devices and asserts their substantial equivalence to predicate devices. As such, it does not detail acceptance criteria or a study proving that an AI/Machine Learning device meets specific performance criteria.

Therefore, most of the requested information regarding AI device performance, sample sizes for test and training sets, ground truth establishment, expert qualifications, and adjudication methods is not applicable to this document. This document focuses on the mechanical and material aspects of surgical implants.

However, I can extract information related to the device and its assessment where applicable:

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

The document does not specify quantitative acceptance criteria in terms of performance metrics (like sensitivity, specificity, or accuracy) because it is not an AI/ML device. Instead, the acceptance is based on demonstrating substantial equivalence to predicate devices through:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This is not an AI/ML device that uses test sets of data for performance evaluation. The "test set" here refers to the actual physical devices undergoing mechanical and biocompatibility testing. The data provenance is internal to Zimmer, Inc. and its testing facilities, following international (ISO) and US (FDA) standards.

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, as this is not an AI/ML device requiring expert-established ground truth. Expert involvement would be in the design and interpretation of the engineering and biocompatibility tests, but not in establishing a "ground truth" for a dataset.

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

Not applicable. There is no adjudication method for a test set in the context of an AI/ML device. The "test set" in this context refers to physical devices undergoing standardized mechanical and biological tests, whose results are interpreted by qualified engineers and scientists.

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/ML device.

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

Not applicable. This is not an AI/ML device.

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

Not applicable in the context of AI/ML. For this medical device, the "ground truth" for its performance is established through:

• Physical and biological testing: Adherence to established engineering standards (e.g., strength, fatigue) and biological safety standards (biocompatibility).
• Comparison to predicate devices: The "ground truth" of safety and effectiveness is largely based on the historical performance and regulatory clearance of the predicate devices.

8. The sample size for the training set

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

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