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The Periarticular Locking Plate System is indicated for temporary internal fixation and stabilization of osteotomies and fractures, including:

• Comminuted fractures .
• Supracondylar fractures .
• Intra-articular and extra-articular condylar fractures .
• Fractures in osteopenic bone .
• Nonunions .
• Malunions .

The Zimmer Periarticular Locking Plate System is a plate and screw system intended for internal fracture fixation. The low-profile periarticular locking plate is anatomically contoured and has threaded holes which accept locking screws to create a stable, fixed angle construct.

The provided text describes the Zimmer Periarticular Locking Plate System, a medical device for fracture fixation. It includes a summary of safety and effectiveness, indicating that non-clinical performance testing demonstrates the device's safety and effectiveness. However, no specific quantitative or qualitative acceptance criteria are explicitly stated in the document.

Here's an analysis based on the information provided, addressing your requested points:

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)

The document primarily discusses "non-clinical (laboratory) performance testing." This generally implies mechanical or functional tests performed in a laboratory setting rather than on human or animal subjects that would have a "test set" in the context of diagnostic or predictive algorithms.

• Sample Size for Test Set: Not applicable or not specified for non-clinical testing; no information on human or animal test sets.
• Data Provenance: "Non-clinical (laboratory) performance testing." No country of origin or retrospective/prospective nature is mentioned as it's not a clinical study.

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 question is not applicable to the type of safety and effectiveness data provided. Non-clinical performance testing typically involves engineering or materials scientists performing standardized tests, not medical experts establishing ground truth for diagnostic purposes.

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

Not applicable to non-clinical performance testing as described. Adjudication methods are typically used in clinical studies or studies involving expert assessment of data (e.g., imaging) to establish ground truth or resolve discrepancies.

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. The document describes a medical device (bone plate system) and its non-clinical performance testing, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies or AI assistance are irrelevant to this submission.

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

Not applicable. The device is a physical implant for fracture fixation, not an algorithm.

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

For non-clinical performance testing of a mechanical device, the "ground truth" is typically established by:

• Engineering specifications and standards: Performance metrics (e.g., yield strength, fatigue life, torsional rigidity) are measured against predefined engineering requirements or industry standards.
• Comparison to predicate device: Performance is often compared to a legally marketed predicate device to demonstrate substantial equivalence.

While not explicitly stated as "ground truth," the tests would be designed to verify that the device meets its design intent and performance characteristics.

8. The sample size for the training set

Not applicable. This is a medical device approval based on non-clinical testing, not a machine learning algorithm that requires a "training set."

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

Not applicable, as there is no "training set" for this type of device submission.

In summary: The provided document is a 510(k) premarket notification for a medical device (a bone plate system). The "study" mentioned refers to "non-clinical (laboratory) performance testing." This type of testing focuses on the mechanical and material properties of the device to ensure it is safe and effective for its intended use, typically by comparing it to a predicate device and meeting engineering standards, rather than involving clinical trials, human data sets, or AI algorithms. As such, many of the questions asked are not applicable to the information contained in this specific document.

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