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The Cook ® Zilver™ Biliary Stent is indicated for use in palliation of malignant neoplasms in the biliary tree.

The Cook® Zilver™ Biliary Stent is a self-expanding, nitonol stent designed for superior radial strength and optimal longitudinal flexibility. Constructed from a series of interconnected Z-shaped seqments, the stent conforms to the shape of the biliary system and provides circumferential scaffolding throughout the stent's length. Gold radiopaque markers on each end of the Zilver™ Biliary Stent, along with radiopaque markers on the delivery system, allow precise positioning of the stent. The stent's interconnected Z-shaped segments also keep foreshortening to a minimum.

The Zilver™ Biliary Stent comes preloaded in a 7.0 Fr. (OD) sheath delivery system. The stent is deployed with the use of a simple hand held device. The stent is being made available in unrestrained outer diameters of 12 and 14mm's and in the lengths of 25, 30, 40, 50, 60 and 80mm's

Here's an analysis of the provided text regarding the acceptance criteria and study for the Cook® Zilver™ Biliary Stent:

1. Table of Acceptance Criteria and Reported Device Performance:

The document provides a list of tests conducted but does not explicitly state specific acceptance criteria (e.g., "stent must deploy within X seconds" or "radial force must be Y Newtons") or quantitative reported device performance values. Instead, it broadly states that the tests provide "reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a biliary stent."

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: The document does not specify the sample size used for any of the tests.
• Data Provenance: The document does not provide information on the country of origin of the data or whether the tests were retrospective or prospective. Given the nature of a 510(k) summary, these are likely in-house laboratory and engineering tests rather than clinical studies with human patient data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not applicable to the type of testing described in the document. The tests performed are engineering and design verification tests, not clinical studies requiring expert consensus on ground truth. Ground truth in this context would be physical measurements and engineering specifications.

4. Adjudication Method for the Test Set:

This information is not applicable as there is no mention of a human-reviewed test set or "adjudication" in the clinical sense. The tests are physical and analytical.

5. 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 is not applicable. The device described is a medical stent, not an AI or imaging diagnostic device that would involve human readers or AI assistance.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

This is not applicable. The device is a physical medical implant, not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for the tests described would be the engineering specifications and design requirements for the stent. For example, the specified diameter of the stent, its intended deployment accuracy, and its required structural integrity. The tests verify that the physical device meets these predefined engineering standards.

8. The Sample Size for the Training Set:

This is not applicable as there is no "training set" in the context of this physical device's testing. Training sets are relevant for machine learning models.

9. How the Ground Truth for the Training Set was Established:

This is not applicable for the reasons stated above.

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