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

The OMNILINK® .035 Biliary Stent System is a balloon-expandable stent compused of .16L medical grade stainless steel. The stent is pre-mounted onto an over-the-wire (OT)N) lefivery catheter. The OMNILINK® .035 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. 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 device OMNILINK® .035 Biliary Stent System consists of stent sizes of diameters ranging from 5.0mm - 10.0mm with stent lengths of 12, 16, 18, 28, 38, 58mm and delivery system length of 80 and 135cm. The stent and delivery system are supplied sterile and is intended for single use only.

The provided text is a 510(k) summary for a medical device, the OMNILINK® .035 Biliary Stent System. This document focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a study proving the device meets specific acceptance criteria through performance data.

Therefore, many of the requested elements (acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance) are not detailed in this type of regulatory submission.

Here's an analysis based on the information provided:

Acceptance Criteria and Device Performance

The provided document does not contain a table of specific quantitative acceptance criteria or corresponding reported device performance metrics from a study. As a 510(k) summary, its primary purpose is to establish substantial equivalence to predicate devices, not to present novel performance data against defined acceptance criteria.

The submission states: "No performance standards have been established for Biliary Stents under Section 514 of the Food, Drug and Cosmetic Act." This indicates that there are no government-mandated acceptance criteria, and the document itself does not specify internal company acceptance criteria for a new performance study.

Absence of a Comprehensive Study Description

The document indicates that studies validating the performance of this specific iteration of the device against new, defined criteria were likely not conducted or, if they were, the details are not included in this summary. The "Performance Data" section simply states, "No performance standards have been established for Biliary Stents under Section 514 of the Food, Drug and Cosmetic Act."

The changes described for this 510(k) (optimized manufacturing parameters, revised test methods, addition of process monitoring, updates to product labeling, and related updates to product specification) suggest modifications to an existing device rather than a new device requiring extensive clinical trials to establish de novo performance.

Given this, the following points cannot be answered from the provided text:

2. Sample sizes used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
4. Adjudication method for the test set: Not mentioned.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs. without AI assistance: Not applicable (this is a physical medical device, not an AI system).
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not mentioned.
8. The sample size for the training set: Not applicable (not an AI system).
9. How the ground truth for the training set was established: Not applicable.

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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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