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Intended for fixation of lateral clavicle fractures and dislocations of the acromioclavicular joint.

The Synthes (USA) Clavicle Hook Plate is an anatomically designed L-shaped plate featuring a distal joint bridging hook with a rounded end. The shaft of the plate contains either dynamic compression screw holes or LCP plate holes. The plate accepts 3.5 mm cortex, 4.0 mm cancellous and 3.5 mm locking screws (LCP Clavicle Hook Plate only).

The provided text is a 510(k) summary and FDA clearance letter for the Synthes (USA) Clavicle Hook Plate. It does not contain information about acceptance criteria or a study demonstrating device performance against such criteria. The document focuses on the device's substantial equivalence to a predicate device for FDA clearance, rather than reporting on specific performance metrics from a clinical study.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Number and qualifications of experts for ground truth establishment.
4. Adjudication method for a test set.
5. MRMC comparative effectiveness study results.
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 document describes a medical device and its regulatory clearance based on substantial equivalence, not a study evaluating its performance against pre-defined acceptance criteria.

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