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The Epic Extremity Cannulated Screw System is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair and fracture fixation of bones appropriate for the size of the device.

Screws are intended for single use only.

The Epic Extremity Cannulated Screw System will consist of multiple diameter headed and headless cannulated screws of various lengths and instruments to assist in implanting the system.

This document is a 510(k) summary for the Epic Extremity Cannulated Screw System, which is a medical device. As such, it does not describe an AI/ML powered device, nor does it contain information about acceptance criteria or a study proving that the device meets those criteria in the context of an AI/ML model's performance.

The document primarily focuses on demonstrating substantial equivalence to predicate devices based on:

1. Intended use and indications for use, which are similar to the predicate devices.
2. Technological characteristics, specifically that the device is manufactured from the same material (Ti-6Al-4V per ASTM F-136) and has a similar range of sizes as the predicate devices.
3. Non-clinical performance data, referencing ASTM F-543.
4. No clinical performance data was required for this 510(k) submission.

Therefore, I cannot provide the requested information. The document explicitly states: "No clinical testing was required," and "No clinical performance data was done."

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