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Deformity of the great toe when it is bent to the outside toward the other toes. Commonly referred and to as: Hallux Valgus

Osteotomy or fracture fixation of the small bones of the hand or foot.

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I am sorry, but based on the provided text, I cannot provide the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is a 510(k) clearance letter from the FDA for a device called "Plaquagrafe and P4V Agrafe". It confirms that the device is substantially equivalent to legally marketed predicate devices and can be marketed.

However, the letter does not contain any information regarding:

1. Specific acceptance criteria or reported device performance metrics.
2. Details about a study to prove the device meets acceptance criteria.
3. Sample sizes, data provenance, number or qualifications of experts, or adjudication methods.
4. Whether a multi-reader multi-case (MRMC) comparative effectiveness study or a standalone algorithm performance study was done.
5. The type of ground truth used or details about the training set.

The document primarily focuses on the regulatory clearance for the device, not the technical details of its performance validation.

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