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The Trilliant Surgical K-wires are intended for use in fixation of bone fractures, for bone reconstructions, and as guide pins for insertion of other implants.

K-wires are sharpened or blunt, smooth stainless steel pins. They come in different sizes and are used to hold bone fragments together (pin fixation) or to provide an anchor for skeletal traction. Two diameters, Ø0.045" (Ø1.143 mm) and Ø0.062" (Ø1.57 mm), of the Trilliant Surgical K-Wires are offered to accommodate various patient anatomies, injuries and/or conditions, and physician preference.

Materials: 316L Stainless Steel per ASTM F138

Function: The K-wires are used to hold bone fragments together (pin fixation), to provide an anchor for skeletal traction and as guide pins for insertion of other implants.

The provided text indicates that no clinical studies were performed for the Trilliant Surgical K-wires. Therefore, there is no information available regarding acceptance criteria or a study proving that the device meets such criteria.

The submission states:

• Clinical Test Summary: "No clinical studies were performed"
• Conclusions Nonclinical and Clinical: "This summary concludes that Trilliant Surgical K-wires are as safe, as effective, and performs as well as the predicate device(s)."

This implies that the substantial equivalence determination was based on non-clinical data, such as a comparison of design, materials, and intended use with a legally marketed predicate device (K-Medic External Fixation Devices - K030336), rather than a performance-based clinical study.

Given the information provided in the input, I cannot fill in the requested table or detail a study that proves the device meets acceptance criteria.

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