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Humeral staples are intended for fixation of two-part proximal humerus fractures and three-part proximal humerus fractures in conjunction with limited internal fixation such as suture wire. The device is intended for single use.

Humeral staples are manufactured from either Stainless Steel (ASTM F 138) or Titanium (ASTM F 1472). The staple features two trocar point ends and suture holes. The staple is designed for intramedullary implantation in the proximal humerus.

The provided text is a 510(k) summary for a medical device called a "Humeral Staple." This type of document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.

Crucially, a 510(k) summary like this one is not a clinical study report. It does not typically contain information about acceptance criteria, detailed device performance metrics, sample sizes for test sets, ground truth establishment, or multi-reader multi-case studies.

Instead, it focuses on demonstrating equivalence to existing devices through comparisons of:

• Intended Use: What the device is designed to treat.
• Device Description: Physical characteristics and materials.
• Technological Characteristics: How it achieves its function.
• Materials: What it's made from.
• Performance Data: (If applicable, usually refers to non-clinical bench testing or engineering analysis for equivalence, not detailed clinical outcomes as would be found in a clinical trial).

Therefore, based solely on the provided text, I cannot extract the information required for your request. The document discusses "substantial equivalence" as the primary "acceptance criteria" for regulatory clearance, not specific performance metrics in a clinical study context.

Here's how I can answer your questions based on what is and is not in the document:

Acceptance Criteria and Study for Humeral Staple (Based on 510(k) Summary)

The primary "acceptance criterion" for the Humeral Staple, as detailed in this 510(k) summary, is Substantial Equivalence to legally marketed predicate devices. This means the new device must be as safe and effective as a legally marketed device that is not subject to premarket approval (PMA).

The "study" demonstrating this is a comparison to predicate devices based on technological characteristics, intended use, and materials. This is a regulatory pathway, not a clinical trial.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size: Not applicable. This document does not describe a clinical test set or human subject data. It's a regulatory submission comparing the device to existing predicate devices.
• Data Provenance: Not applicable. The comparison is based on the characteristics of the Humeral Staple itself and information about the predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable. There is no test set in the clinical sense, and no ground truth established by experts for human studies described in this summary. Regulatory review involves FDA experts.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• Not applicable. No test set described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This is not an AI/medical imaging device. It is a surgical implant.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• Not applicable. This is not an algorithm-based device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Not applicable in the context of clinical "ground truth." The "ground truth" for regulatory clearance is the established safety and effectiveness of the legally marketed predicate devices that the Humeral Staple is compared against.

8. The sample size for the training set

• Not applicable. There is no "training set" as this is not a machine learning or AI device.

9. How the ground truth for the training set was established

• Not applicable.

In summary, this 510(k) document is a regulatory submission focused on demonstrating equivalence to existing devices, not a report of a clinical performance study with defined acceptance criteria and detailed device metrics.

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