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The Arthrex Humeral Fracture Plates and Screws are intended to provide internal fixation of fractures of the humerus.

The Arthrex Humeral Fracture Plate is designed as a spoon shaped plate to The Anthrox fiamonee lateral proximal aspect of the humerus. The plate is available in two size configurations, standard and long. Spherical holes with available in the for angular locking of the screws in the plate. Smaller holes in the center of the plate allow for temporary fixation during surgery with K-wires. Peripheral holes allow re-approximation of soft tissue with suture, such as FiberWire®. The screws are available in various lengths in two design options, cortical and cancellous. The cortical screws are 3.5 mm in diameter and the cancellous screws are 4.0 mm in diameter.

This 510(k) premarket notification for the Arthrex Small Fragment Plates and Screws (specifically the Arthrex Humeral Fracture Plates & Screws) is focused on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria or reporting performance from a clinical study.

Therefore, the input document does not contain the information requested regarding acceptance criteria, device performance, study details, expert involvement, or ground truth establishment for a device study.

The document is a 510(k) summary, which typically focuses on:

• Identification of the device: Trade name, common name, classification, product code.
• Sponsor information.
• Predicate devices: Listing similar, legally marketed devices to which substantial equivalence is being claimed.
• Device description: How the device works and its features.
• Intended use/indications for use.
• Statement of substantial equivalence.
• FDA's response letter: Confirmation of substantial equivalence.

Without a clinical study or performance data presented in the provided text, I cannot fill in the requested table or answer the specific questions about acceptance criteria, study design, or results.

Summary of missing information:

1. Acceptance criteria and reported device performance: Not present. The document focuses on substantial equivalence to existing devices, not new performance metrics against specific criteria.
2. Sample size and data provenance: No study data is provided.
3. Number and qualifications of experts for ground truth: Not applicable as no study is detailed.
4. Adjudication method: Not applicable.
5. MRMC comparative effectiveness study: Not mentioned or applicable here.
6. Standalone (algorithm only) performance: Not applicable as this is a medical device (plate and screws), not an algorithm.
7. Type of ground truth: Not applicable.
8. Sample size for training set: Not applicable.
9. How ground truth for training set was established: Not applicable.

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