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Synthes (USA) LCP Proximal Humerus Plate, long is indicated for fractures and fracture dislocations, osteotomies, and non-unions of the proximal humerus, particularly in osteopenic bone.

The Synthes LCP Proximal Humerus Plates, long are pre-contoured to match the anatomy of the proximal humerus with a limited contact low profile design. The plate features locking holes and combination locking and compression holes which accept 2.7, 3.5, & 4.0 mm cortex screws, 3.5 mm locking screws, and 4.0 mm cancellous screws. The System will be available in Stainless Steel and Titanium. These plates will be offered as an addition to the Synthes Small Fragment LCP (formerly DCL) System.

The provided document is a 510(k) summary for the Synthes LCP Proximal Humerus Plates, long. It details the device's classification, predicate devices, description, and intended use. However, it does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The document explicitly states under "Substantial Equivalence": "Documentation is provided which demonstrates that Synthes LCP Proximal Humerus Plates, long is substantially equivalent to other legally marketed Synthes devices." This indicates that the device was approved based on its substantial equivalence to previously cleared predicate devices, rather than through a new clinical or performance study establishing specific acceptance criteria and demonstrating achievement of those criteria.

Therefore, I cannot provide the requested information, which includes:

1. A table of acceptance criteria and the reported device performance
2. Sample sized used for the test set and the data provenance
3. Number of experts used to establish the ground truth
4. Adjudication method
5. MRMC comparative effectiveness study
6. Standalone performance study
7. Type of ground truth used
8. Sample size for the training set
9. How the ground truth for the training set was established

This type of information is typically found in premarket approval (PMA) applications or more detailed clinical study reports, not usually in a 510(k) summary based on substantial equivalence.

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