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The AOS Anterolateral Proximal Humeral Plate is indicated for fracture dislocations, osteotomies, and nonunions of the proximal humerus.

The AOS Anterolateral Proximal Humeral plates are open reduction internal fixation devices for the temporary fixation of various types of fractures of the humerus and are intended as load sharing devices which may be removed once the fracture has healed. The AOS Anterolateral Proximal Humeral System consists of titanium plates, and proximal and distal locking and non-locking screws.

The provided text describes a 510(k) premarket notification for the "AOS Anterolateral Proximal Humeral Plate." This document is an FDA letter recognizing the device as substantially equivalent to a legally marketed predicate device. As such, it does not contain acceptance criteria or a study proving the device meets those criteria, as these are typically part of a performance study, not a substantial equivalence claim.

Substantial equivalence is established primarily by demonstrating that the new device has the same intended use and the same technological characteristics as the predicate device, or if there are differences, that they do not raise new questions of safety and effectiveness. The document explicitly states: "physical testing was deemed unnecessary, and substantial equivalence was determined in strength and geometry between the proposed plates and predicate plates."

Therefore, based on the provided text, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets them because such a study was not deemed necessary for this 510(k) submission.

Specifically, I cannot extract:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and their qualifications
4. Adjudication method for the test set
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
6. If a standalone (algorithm only) performance study was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

The document focuses on explaining that the new device (AOS Anterolateral Proximal Humeral Plate) is substantially equivalent to a previously cleared predicate device (AOS Proximal Humeral Plate, K080590) because they share the same indications for use, similar geometry and design, fundamental scientific technology, and material.

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