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OMNILINK® .035 Biliary Stent System is indicated for palliation of malignant strictures in the biliary tree.

OMNILINK® .035 Biliary Stent System is intended as a palliative treatment of malignant neoplasms in the biliary tree.

The OMNILINK® .035 Biliary Stent System is comprised of a stainless steel, balloonexpandable stent pre-mounted onto an over-the-wire (OTW) delivery catheter. This system is designed for percutaneous placement in the common bile duct and intended to treat malignant strictures in the biliary tree.

The OMNILINK® Biliary Stent consists of a dual stent design, fabricated from a single piece of 316L medical grade stainless steel tubing. The delivery catheter's central lumen is designed to permit the use of a 0.035" guide wire to facilitate advancement of the catheter to and through the stricture to be dilated. Once the delivery system is placed in the desired location, the stent expands upon inflating the balloon with contrast medium. The balloon provides an expandable segment of known diameter and length at specific pressures. In addition, the balloon has two radiopaque markers to aid in stent positioning. The stent is designed to remain in the biliary duct as a permanent implant.

The subject OMNILINK® .035 Biliary Stent System consists of additional stent sizes of 4.0, 5.0, 6.0, 7.0mm stent diameter, 12 and 16mm stent lengths, and 4.0mm stent diameter x 18mm stent length. The stent and delivery system are supplied sterile and intended for single use only.

The provided text is a 510(k) summary for the OMNILINK® .035 Biliary Stent System. This document describes a medical device, a biliary stent, and its substantial equivalence to a predicate device, rather than an AI/ML powered device. As such, the requested information regarding acceptance criteria and study details for an AI-powered device cannot be extracted from this document because it does not pertain to AI/ML.

The device discussed is a physical medical device (a stent) and the "performance data" mentioned refers to traditional in vitro bench tests, not studies involving algorithms, ground truth establishment by experts, or human-in-the-loop performance with AI assistance. Therefore, most of the requested fields are not applicable to the provided content.

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