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The EPIC Extremity Small Staple is indicated for use in fixation of bone fractures or bone reconstruction. Examples include:

• Wedge osteotomy of the first phalanx (Akin osteotomy)

• Treatment of hallux valgus in order to correct valgus or pronation of the first ray

• Wind swept toes

The Small Staple is intended for single use only

The EPIC Extremity Small Staple will consist of one size and style, and instruments to assist in implanting the device.

This document, K163226, is a 510(k) premarket notification for the EPIC Extremity Small Staple. It concludes that the device is substantially equivalent to a predicate device, but it does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of AI/ML performance.

Instead, this document focuses on demonstrating substantial equivalence based on:

• Intended Use and Indications for Use: Stating they are similar to the predicate device.
• Technological Characteristics: Highlighting similarities in materials and size range.
• Non-Clinical Performance Data: Comparing the subject device's static bend testing, fatigue bend testing, and pullout testing performance to the predicate device.
• Clinical Performance Data: Explicitly stating that "No clinical testing was required."

Therefore, based on the provided text, I cannot answer the requested questions about acceptance criteria or a study proving device performance in the context of AI/ML. The provided information pertains to the physical characteristics and mechanical performance of a medical staple for bone fixation, not an AI/ML device.

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