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Synthes Spiral Blade for Humeral Nail is intended to stabilize fractures of the humerus.

Synthes Spiral Blade is used in conjunction with Synthes Solid Humeral Nail. The Synthes SBHN has a self-cutting blade tip, is cannulated, has suture holes located around periphery of blade head, and is available in lengths ranging from 34 mm to 54 mm. A Locking End Cap is used to lock the Spiral Blade in place.

I am sorry, but the provided text does not contain detailed information about acceptance criteria and a study proving a device meets those criteria. The document is primarily a 510(k) summary and an FDA clearance letter for a medical device called the "Synthes Spiral Blade for Humeral Nail."

The document focuses on the regulatory clearance process, device description, intended use, and substantial equivalence to a predicate device. It confirms that the FDA reviewed the submission and found the device substantially equivalent.

Therefore, I cannot provide the requested information, including:

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.
4. Adjudication method.
5. MRMC comparative effectiveness study details or effect size.
6. Standalone performance study details.
7. Type of ground truth used.
8. Training set sample size.
9. How ground truth for the training set was established.

This type of detailed study information is typically found in the full 510(k) submission or associated clinical/testing reports, which are not provided in this excerpt.

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