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The Guidant OMNILINK® .018 Biliary Stent System is intended for palliation of malignant strictures in the biliary tree.

The OMNILINK® .018 Biliary Stent System is a balloon-expandable stent composed of 316L medical grade stainless steel. The stent is pre-mounted onto an over-the-wire (OTW) delivery catheter.

The OMNILINK® .018 Biliary Stent System consists of a dual stent design, fabricated from a single piece of 316L medical grade stainless steel tubing. The stent designs are based on a series of zigzagging rings with multiple articulations per ring. The stents are available in two designs which primarily differ in strut width and the length of the basic cell. One design is used for stent sizes 5.0mm - 7.0mm and the other for stent sizes 8.0mm - 10.0mm.

The delivery system is an over-the-wire, co-axial design with a balloon at the distal end. delivery catheter's central lumen is designed to permit the use of a 0.018" 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 device OMNILINK® .018 Biliary Stent System consists of stent sizes of diameters ranging from 5.0mm - 10.0mm with stent lengths of 18, 28, 58mm and delivery system length of 80 and 135cm. The stent and delivery system are supplied sterile and is intended for single use only.

This document pertains to a 510(k) submission for the GUIDANT OMNILINK® .018 Biliary Stent System. The submission focuses on demonstrating substantial equivalence to pre-existing predicate devices and does not describe a study involving formal acceptance criteria for device performance based on a clinical trial with human subjects and AI.

Therefore, the following information cannot be extracted from the provided text:

• A table of acceptance criteria and the reported device performance: The document explicitly states, "No performance standards have been established for Biliary Stents under Section 514 of the Food, Drug and Cosmetic Act." This indicates that the approval is not based on meeting specific, pre-defined performance metrics from a study described here. The 510(k) process for this device relies on demonstrating substantial equivalence to predicate devices, not on proving de novo performance against a set of acceptance criteria.
• Sample size used for the test set and the data provenance: No test set is described in the context of a performance study.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment is described.
• Adjudication method for the test set: No adjudication method is described.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance: This device is a physical medical device (stent), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance is not applicable.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable as this is not an algorithm.
• The type of ground truth used: Not applicable as no ground truth is discussed in the context of a performance study.
• The sample size for the training set: Not applicable as there is no mention of a training set for an algorithm.
• How the ground truth for the training set was established: Not applicable as there is no mention of a training set or ground truth for it.

Summary of Device Approval Approach:

The approval of the OMNILINK® .018 Biliary Stent System is based on demonstrating substantial equivalence to previously approved predicate devices (OTW MEGALINK® SDS Biliary Stent System (K992319) and OMNILINK® .018 Biliary Stent System (K011039 and K033834)). The changes described in this 510(k) are related to "optimized manufacturing parameters, revised test methods, addition of process monitoring, updates to the product labeling and related updates to the product specification," rather than a new clinical performance study against specific acceptance criteria.

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The OMNILINK® .018 Biliary Stent System is indicated for palliation of malignant strictures in the biliary tree.
The OMNILINKR® .018 Biliary Stent System is intended for palliation of malignant strictures in the biliary tree.

The OMNILINK® .018 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 0.018" 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 prositioning. The stent is designed to remain in the biliary duct as a permanent implant.
The subject OMNILINK® .018 Biliary Stent System consists of additional stent sizes of 110 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 describes a 510(k) submission for a medical device, the OMNILINK® .018 Biliary Stent System. While it details the device, its intended use, and substantial equivalence to predicate devices, it does not contain information about acceptance criteria or a study proving that the device meets such criteria.

The document states: "The safety and effectiveness of the subject OMNILINK® .018 Biliary Stent System has been demonstrated through data collected from in vitro bench tests and analyses." This indicates that performance data was collected, but the specifics requested in your prompt (like acceptance criteria, sample sizes, ground truth, expert involvement, or comparative effectiveness studies) are not present in this document.

Therefore, I cannot populate the table or answer the specific questions based on the provided text. The document is primarily a regulatory submission summarizing the device and its equivalence, rather than a detailed report of clinical or performance studies.

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Ask a specific question about this device