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This device is used for palliative treatment of duodenal or gastric outlet obstruction and duodenal strictures caused by malignant neoplasms.

Stent Description: This flexible, self-expanding stent is constructed of nitinol wire. The total length of the stent is indicated by radiopaque markers on the inner catheter, indicating the actual length of the stent at nominal stent diameter. The stent has flanges at both stent ends.
Introducer System Description: The stent is mounted on an inner catheter, which accepts a 0.035 inch wire guide and is constrained by an outer catheter. A pistol-grip delivery handle allows stent deployment or recapture.

I cannot fulfill this request. The provided text, including the "510(k) Summary," describes a medical device (Evolution™ Duodenal Stent System) and its intended use, but it does not contain any information about acceptance criteria, device performance, a study to prove acceptance, sample sizes, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.

The text focuses on:

• Device description
• Indications for use
• Comparison to predicate devices
• General statement about performance (bench and clinical) testing being carried out to determine equivalence and verify safety/effectiveness, listing types of bench tests.

It does not provide the detailed results or methodology of these tests in a way that would allow me to answer your specific questions about acceptance criteria and study particulars. The document concludes with the FDA's clearance letter, stating the device is substantially equivalent to predicate devices.

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