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The VIABIL® Biliary Endoprosthesis is indicated for the treatment of malignant biliary strictures.
The GORE VIABIL® Biliary Endoprosthesis is intended for palliation of malignant strictures in the biliary tree.

The VIABIL® Biliary Endoprosthesis is a flexible, self-expanding stent with an inner tubular lining that is radially compressed and secured to the distal end of a delivery catheter. The catheter provides a means for implanting the VIABIL® Biliary Endoprosthesis at the target site in the biliary tract.
There are two principle components of the device: the endoprosthesis and the delivery catheter. The endoprosthesis is available in two diameters (8 mm and 10 mm), four lengths (4 cm, 6 cm, 8 cm, and 10 cm), and is available both with and without transmural drainage holes. Two catheter lengths are available: a 40 cm working length catheter for percutaneous delivery of the endoprosthesis, and a 200-cm working length catheter for endoscopic delivery.

This document is a 510(k) Premarket Notification Summary for the VIABIL® Biliary Endoprosthesis, submitted by W. L. Gore and Associates Inc. and reviewed by the FDA in 2008. The notification seeks to demonstrate substantial equivalence to predicate devices. The document does not contain a study section that describes acceptance criteria and reported device performance through a formal study with a test set, expert involvement, or specific statistical methodologies.

Therefore, most of the requested information cannot be extracted from the provided text.

Here's a breakdown of what can and cannot be answered:

1. A table of acceptance criteria and the reported device performance

This information is not present in the provided text. The document states "Based on a variety of tests, assessments, and comparisons of the applicant device to the predicate devices demonstrate that the VIABIL® Biliary Endoprosthesis is substantially equivalent to its predicate in terms of material composition, design, intended use, and performance attributes." However, it does not detail what these "tests, assessments, and comparisons" were, what their specific acceptance criteria were, or the quantitative performance results.

Remaining points (2-9) cannot be answered as they relate to a study which is not detailed in the provided text.

Summary of what cannot be extracted from the provided text:

• Sample size used for the test set and the data provenance.
• Number of experts used to establish the ground truth for the test set and their qualifications.
• Adjudication method for the test set.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or an effect size.
• If a standalone (algorithm only) performance study was done.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
• The sample size for the training set.
• How the ground truth for the training set was established.

The provided text focuses on the device description, intended use, and the regulatory determination of substantial equivalence, not on the details of a specific performance study with clearly defined acceptance criteria and results.

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