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Temporary internal fixation devices are designed to stabilize fractures during the normal healing process.

The Zimmer® Periarticular Plating System - Screws are similar in intended use, type of materials, and performance characteristics to the predicate devices (Zimmer Periarticular Locking Plate System - K042598, cleared 10/29/2004). The proposed screws are provided sterile vs. non-sterile.

The provided text is a 510(k) summary for the Zimmer® Periarticular Plating System - Screws. This document focuses on the non-clinical performance and substantial equivalence to predicate devices, rather than a study with a test set, experts, or ground truth as would be typical for an AI/ML medical device.

Therefore, many of the requested fields are not applicable to this type of regulatory submission. The device described is a physical surgical screw, not a software algorithm or an AI-enabled device.

I will fill in the available information and explicitly state when a requested field is not applicable based on the provided text.

Acceptance Criteria and Device Performance for Zimmer® Periarticular Plating System - Screws

Study Details:

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

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 applicable. This submission is for a physical medical device (screws) and relies on non-clinical (lab) performance testing and engineering evaluations, not a "test set" of data in the context of an AI/ML device. The various tests (biocompatibility, sterilization, shelf life, mechanical testing) would have involved a sufficient number of samples for those specific tests.
   • Data Provenance: Not applicable. This refers to laboratory testing and engineering evaluations.

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. Ground truth as typically defined for AI/ML performance evaluation (e.g., expert consensus on medical images) is not relevant for the non-clinical testing of a physical device. Testing was conducted by qualified personnel in laboratories following established standards and good laboratory practices.

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

   • Not applicable. This concept is for resolving disagreements in expert labeling of data, which is not part of this device's non-clinical performance evaluation.

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 a physical orthopedic screw, not an AI/ML diagnostic or assistive device.

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

   • Not applicable. This is a physical orthopedic screw, not an algorithm.

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

   • The "ground truth" for this device's performance evaluation is based on established engineering principles, material science standards (e.g., ISO 10993-1), and regulatory requirements (e.g., sterilization to a SAL ≥ 10^-6, accelerated aging for shelf life, mechanical properties testing). These are objective measurements and validations, not expert consensus on qualitative data.

8. The sample size for the training set:

   • Not applicable. There is no "training set" as this is not an AI/ML device.

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

   • Not applicable.

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