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The WishBone K-Wire System, is intended to be used for fixation of pediatric bone fractures, bone reconstruction; and guide pins for insertion of other implants.

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This document is a 510(k) clearance letter from the FDA for the WishBone K-Wire System. It indicates that the device has been found substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain any information about acceptance criteria or specific study data proving the device met those criteria. The document is a regulatory clearance letter, not a clinical study report or a technical performance specification document.

Therefore, I cannot provide the requested information based on the input text. The questions asked are typically addressed in a clinical or performance study report that would be submitted to the FDA as part of the 510(k) application, but this letter is the FDA's response to that application, not the application itself.

To answer your questions, I would need a different type of document, such as:

• A summary of safety and effectiveness (SSE) for the 510(k).
• A clinical study report.
• A performance testing report.

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