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The Tornier humeral plate is indicated for simple or complex fractures, fracture dislocations, osteotomies, and non-unions of the proximal humerus.

The Unity Humeral plate is intended to provide a temporary fixation of proximal humerus fractures. It is pre-contoured to fit the anatomical profile of the proximal humerus. The plate combines orientable screws, locking screws and cortical screws to provide compression and angular stable locking.

The provided text is a 510(k) Premarket Notification for the "Unity Humeral Plate" and does not contain information about acceptance criteria or a study proving device performance against such criteria.

The document establishes substantial equivalence to predicate devices (Synthes LCP Proximal Humerus Plates, Long, K041860; Numelock II System (Lateral Proximal Humerus Plate), Howmedica Osteronics Corporation, K041709) based on device description, materials, and intended use.

Therefore, I cannot provide the requested information, including:

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

This type of 510(k) submission generally focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than presenting novel performance studies against specific acceptance criteria like those expected for AI/ML-driven devices.

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