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The Synthes (USA) Small Titanium Wrist Fusion Plate is intended for use in plate fixation for wrist arthrodesis in patients with disorders such as cerebral palsy, brachial plexopathy, spinal cord injuries, and trauma. This plate addresses the smaller stature and pediatric patient by having a low profile construct and utilizing small screws.

The Synthes small titanium wrist fusion plate is a low profile plate with a 2.1 mm thickness, a proximal width of 8mm and a distal width of 6 mm. The plate uses a total of 8 holes across the 107 mm pre-contoured length. There are proximal and distal holes which utilizes 2.7 mm and 2.4mm screws. Limited contact undercuts are included to minimize plate to bone contact and the ends are tapered in thickness for minimal soft tissue irritation.

This submission is from 2003, and the provided text for K023879 does not contain information about acceptance criteria or a study proving that the device meets such criteria. The document is primarily a 510(k) summary and the FDA's clearance letter, which focuses on demonstrating substantial equivalence to predicate devices rather than detailed performance study results against specific acceptance criteria.

Therefore, I cannot provide the requested information from the text provided. The document outlines the device description, intended use, material, and classification, along with the predicates. It doesn't include:

1. A table of acceptance criteria and the reported device performance.
2. Sample size, data provenance, number of experts, adjudication method, or ground truth for a test set.
3. Whether a MRMC comparative effectiveness study was done.
4. Whether a standalone performance study was done.
5. Sample size for the training set or how ground truth for it was established.

Medical device submissions, particularly older ones like this 510(k), often do not publicly disclose the detailed performance data and acceptance criteria in the summary document. These details are typically part of the full submission reviewed by the FDA but are not always part of the public-facing summary or clearance letter, especially when substantial equivalence is proven through design similarities, material biocompatibility, and intended use comparison, rather than extensive clinical performance studies.

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