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The Xpert Self-Expanding Transhepatic Biliary Stent System is intended for use in the palliation of malignant strictures in the biliary tree.
The Abbott Vascular Devices Xpert™ Self-Expanding Transhepatic Biliary Stent System is intended for use in the palliation of malignant neoplasms in the biliary tree.

The Xpert Self-Expanding Transhepatic Biliary Stent System is comprised of a delivery system and a self-expanding stent. The delivery system is an over the wire (OTW) system designed to deliver the self-expanding Xpert Biliary Stent to the biliary tree.

This is a 510(k) summary for a medical device and does not contain information about studies with acceptance criteria or performance metrics in the way that an AI/ML device submission would. The document describes a traditional medical device (a stent system) and relies on substantial equivalence to a predicate device rather than performance determined through clinical studies with specific acceptance criteria.

As such, I cannot provide the requested information (table of acceptance criteria, sample sizes, expert qualifications, etc.) because it is not present in the provided text. The submission focuses on device description, intended use, and a claim of substantial equivalence based on non-clinical testing.

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