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Synthes Dorsal Distal Radius Plate is intended for fixation of fractures, osteotomies and carpal fusions involving the distal radius, applied to the dorsal aspect.

Synthes Dorsal Distal Radius Plate is PI shaped, with two proximal arms (shaft) and one distal arm (head). The plate is precontoured, and is available in right and left versions. The plate can be cut to size, and there are four compression holes and one round hole in each proximal arm (shaft) that accept 2.7 mm cortex screws, and seven internally threaded holes in the distal arm (head) that accept 1.8 mm threaded head buttress pins or 2.4 mm cortex screws. It is manufactured from a Titanium alloy.

This document is a 510(k) summary for a medical device called the "Synthes Dorsal Distal Radius Plate." It describes the device, its intended use, and compares it to a predicate device (Zimmer Small T-Plate, Oblique).

Crucially, this document describes a comparison of two physical medical devices based on mechanical test results, not a study of an AI/ML algorithm or a diagnostic device.

Therefore, most of the requested information regarding acceptance criteria for AI algorithms, sample sizes for test/training sets, expert ground truth, MRMC studies, or standalone performance of an algorithm does not apply to the content provided.

Here's how to interpret the available information in the context of device approval, where applicable:

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

   Acceptance Criteria	Reported Device Performance
   At least equivalent to the Zimmer Small T-Plate, Oblique based on mechanical test results.	Synthes Dorsal Distal Radius Plate is at least equivalent to the Zimmer Small T-Plate, Oblique based on the mechanical test results of both devices.

   • Explanation: The acceptance criterion is about demonstrating equivalency in mechanical properties to a predicate device. The reported performance directly states this equivalency was met through mechanical testing.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • This question is not applicable. The comparison is based on mechanical tests of physical devices, not a 'test set' of data in the context of AI/ML or human observational studies. The "data" are the results of physical strength or durability tests on the plates themselves. The document does not specify the number of plates tested or the origin of the plates/testing lab, but it's fundamentally a product test, not a clinical data test.

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. "Ground truth" in this context would refer to the true mechanical properties of the devices, which are established through standardized engineering tests, not human expert consensus.

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

   • This question is not applicable. Adjudication methods are relevant for ambiguous or subjective evaluations, typically in clinical or observational studies. Mechanical testing relies on objective measurements.

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 question is not applicable. An MRMC study is relevant for evaluating the diagnostic performance of software or human readers, particularly with AI assistance. This document describes mechanical testing of a physical implant.

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

   • This question is not applicable. "Standalone performance" refers to the performance of an algorithm without human intervention. This document deals with mechanical testing of an orthopedic plate.

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

   • Ground Truth: The "ground truth" for this comparison is the mechanical performance of the predicate device (Zimmer Small T-Plate, Oblique). The Synthes plate's performance is measured against this established physical characteristic. This is determined through standardized engineering tests (e.g., fatigue, static bending, torsional strength).

8. The sample size for the training set

   • This question is not applicable. There is no 'training set' in the context of mechanical device testing.

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

   • This question is not applicable. There is no 'training set' for this type of device submission.

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