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The DePuy Proximal Tibia Plating System is intended for treatment of nonunions, osteotomies, malunions, osteopenic bone and fractures of the proximal tibia, including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar combination of lateral wedge and depression, periprosthetic and fractures with associated shaft fractures.

The technological characteristics of the DePuy Proximal Tibia Plating System are similar to the predicate devices including design and material.

This document is a 510(k) summary for a medical device called the "Proximal Tibia Plating System." It describes the device's intended use and its substantial equivalence to previously marketed devices. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, expert ground truth, or adjudication methods.

The document states: "The DePuy Proximal Tibia Plating System is substantially equivalent to currently marketed devices as demonstrated with pre-clinical data. No new issues of safety or efficacy have been raised." This indicates that the demonstration of substantial equivalence relied on pre-clinical data, likely bench testing or engineering analyses, rather than clinical studies involving human subjects or extensive performance evaluations against specific acceptance criteria.

Therefore, I cannot provide the requested information from the given text.

Based on the provided text, the following information is NOT available:

1. A table of acceptance criteria and the reported device performance: This document only describes the device and its intended use, not performance metrics or acceptance criteria.
2. Sample size used for the test set and the data provenance: No test sets or clinical data are mentioned. The equivalence is based on "pre-clinical data."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No experts or ground truth establishment is described.
4. Adjudication method for the test set: No test set or adjudication is mentioned.
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: This device is a bone fixation system, not an AI-powered diagnostic tool, so an MRMC study is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as it's not an algorithm.
7. The type of ground truth used: Not applicable, as there's no clinical performance study described.
8. The sample size for the training set: Not applicable, as there's no mention of a training set for an algorithm.
9. How the ground truth for the training set was established: Not applicable.

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