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This device is used in palliation of malignant neoplasms in the biliary tree.

Stent Description: This flexible, self-expanding stent is constructed of nitinol wire with a radiopaque core. Both ends of the stent have an increased diameter called flanges intended to provide resistance to migration. The total length of the stent in its collapsed state is indicated by radiopaque markers on the inner catheter assembly. The stent is provided in either of two body diameters 8mm or 10mm and in the following lengths 4, 6, 8 or 10cm.

Stent Delivery System Description: The stent is mounted on an inner catheter, which accepts a 0.035" wire guide and is constrained by an outer sheath. A pistol-grip delivery handle allows stent deployment or recapture. The introducer sheath diameter is 8.5Fr and the working length is 200cm.

The provided text describes the Cook Ireland Evolution® Biliary Stent System. Here's an analysis of the provided information concerning acceptance criteria and supporting studies, formatted as per your request:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document refers to "Performance (bench) testing" which was "successfully completed." However, it does not specify the sample size used for the test sets for any of the individual bench tests (deployment, expansion force, etc.).

The data provenance is laboratory bench testing, presumably conducted by or for Cook Ireland Ltd. The country of origin for the data is not explicitly stated beyond Cook Ireland Ltd.'s address in Limerick, Ireland. The study is a retrospective evaluation of device characteristics against pre-defined engineering and regulatory standards, rather than a prospective clinical trial.

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

This information is not provided in the document. Bench testing typically relies on engineers and technicians to execute tests and interpret results against established specifications, rather than clinical experts establishing a "ground truth" in the same way it would be done for diagnostic AI.

4. Adjudication Method for the Test Set

This information is not provided. Bench testing is usually less about adjudication and more about objective measurements against pre-defined pass/fail criteria.

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

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This device is a physical medical device (a stent and its delivery system), not an AI algorithm. Therefore, the concept of human readers improving with or without AI assistance is not applicable.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

No, a standalone performance study in the context of an algorithm or AI was not done. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

For the bench testing, the "ground truth" was established by predetermined technical specifications, engineering standards (e.g., ASTM standards), and regulatory guidance (FDA's Guidance for the Content of Premarket Notifications for Metal Expandable Biliary Stents). The device's performance was measured against these objective, quantitative criteria.

8. The Sample Size for the Training Set

This information is not applicable/not provided. There is no mention of a "training set" as this is a physical medical device and not an AI/machine learning model.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable/not provided for the same reason as point 8.

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