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The EGIS Biliary Single Bare Stent is indicated for the palliation of malignant strictures in the biliary tree.

Single bare stent has straight and round cylinder form made of a Nitinol wire. It is woven twice in V-hook type by one wire. The cell size is approximately 2 mm. The end of wire is tied by the both wires. No bonding material is used. Single Bare Stent is manufactured by continuous works, V and Twist structure manufacturing process. From these processes, design of Single bare stent has the 12 bends and 2mm cell size. 2mm cell size has the merit to prolong the time that tissue grows up into the stent. In addition, Single Bare Stent designed to have the Radial force, Flexibility and conformability. Single Bare Stent has 6 markers in diameter 6, 7, and 8mm in size and 8 markers in diameter 10mm in size; 2 or 3 markers at both sides and 2 markers at the center. Markers are made of Gold-plated Tungsten wire. They are intended to identify the location of the loaded stent through X-ray.

The provided document is a 510(k) summary for a medical device (EGIS Biliary Single Bare Stent). It does not describe acceptance criteria for an AI/ML-based medical device, nor does it detail a study proving such a device meets acceptance criteria.

The document states: "Clinical testing was not required for this submission." This explicitly indicates that the submission did not include a clinical study (which would be necessary to establish acceptance criteria for an AI/ML device's performance in a clinical setting).

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving device performance for an AI/ML device from this document. The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical bench testing and material comparisons for a physical medical device (a stent), not an AI/ML algorithm.

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