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The Synthes (USA) 2.4mm LCP Wrist Plate is intended for colles' and distal radius fractures with dorsal angulation of the distal fragment.

The 2.4 mm LCP Wrist Plate is a pre-contoured plate which is positioned dorsolaterally on the distal radius and affixed to the second metacarpal to span the wrist. A low profile construct is maintained by incorporating a 2.6 mm thickness, and a width of 7.5 mm. The plate has combination and DCU holes which accept 2.4 mm cortex and 2.4 mm locking screws. The plate is made out of Stainless Steel with tapered ends and is 170 mm in length.

The provided text is a 510(k) summary for the Synthes (USA) 2.4 mm LCP Wrist Plate. This document describes a medical device, its intended use, and its substantial equivalence to a predicate device, which is a regulatory pathway for certain medical devices in the US.

However, the provided text does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria. It is a regulatory filing, not a clinical or performance study report.

Therefore, I cannot provide the requested information, specifically:

1. A table of acceptance criteria and the reported device performance: Not present.
2. Sample size used for the test set and the data provenance: Not present.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present.
4. Adjudication method: Not present.
5. MRMC comparative effectiveness study: Not present. This device is a bone fixation plate, so an MRMC study related to AI assistance would not be applicable.
6. Standalone performance study: Not present.
7. The type of ground truth used: Not present.
8. The sample size for the training set: Not present.
9. How the ground truth for the training set was established: Not present.

The document discusses the device's name, classification, predicate device, description, and intended use for regulatory purposes, concluding with an FDA letter finding substantial equivalence. There are no performance metrics or study details to extract for the questions asked, as these are typically found in separate performance reports or clinical data submissions, not in a 510(k) summary itself for this type of device.

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