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The Biliary Wallstent® Endoprosthesis with Monorail Delivery System is indicated for use in the treatment of biliary strictures produced by malignant neoplasms.

The Boston Scientific Medi-Tech Transhepatic Biliary Wallstent Endoprosthesis with Monorail Delivery System consists of the following components:

• Biliary Stent
• Monorail Delivery System

The Biliary Wallstent covered in this submission is a self-expanding endoprosthesis constructed of biomedical DFT (drawn filled tubing) monofilament wires, braided in a tubular mesh configuration. It is designed to self-expand to a specified diameter following deployment into the stricture. The Biliary Wallstent is provided pre-mounted on a monorail type delivery system.

The stent will be available in unconstrained diameters of 6.0, 8.0 and 10.0 mm. The three stent diameters will be available in the following lengths.

The monorail delivery instrument consists of two coaxially arranged shafts: an inner shaft made of stainless steel proximally and thermoplast distally, and an outer sheath made of thermoplast. The central lumen within the inner shaft continues to the tip and accepts a 0.014" guide wire through the distal tip that exits the inner through two guide wire holes (inner and outer exit holes).

The stent is pre-loaded on the stent carrier located on the distal segment of the inner shaft. Two radiopaque markers on the inner shaft and one radiopaque marker on the retractable outer shaft are used to facilitate stent placement. The proximal end of the stent is firmly held on the inner shaft with a stent holder, which enables a partially deployed stent to be recaptured and repositioned, if desired. A black release marker on the proximal stainless steel shaft identifies the maximum deployment allowable for recapture of the stent.

The distal end of the outer sheath covers the stent and is retracted to allow for stent deployment. The space between the coaxial inner shaft and the outer sheath is accessed through the T-connector. All catheter models have the same overall length.

The provided document describes a Special 510(k) Notification for the Boston Scientific Medi-Tech Transhepatic Biliary Wallstent Endoprosthesis with Monorail Delivery System. This is a premarket notification for a medical device seeking clearance to market, not a study proving device performance against specific acceptance criteria in a clinical setting. The document primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical (in-vitro) testing.

Therefore, many of the requested categories for a clinical study on device performance, such as sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, are not applicable or available in this document.

Here’s an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" with numerical targets for each test, nor does it provide detailed quantitative results. Instead, it lists the types of non-clinical tests performed and states that "All in-vitro test results verified that the Biliary Wallstent Endoprosthesis with Monorail Delivery System is adequate for its intended use."

2. Sample size used for the test set and the data provenance

• Sample Size: Not specified. The document refers to "testing" conducted, but does not provide the number of devices or components tested for each non-clinical evaluation.
• Data Provenance: Not applicable. These were in-vitro, non-clinical tests performed by the manufacturer, not data derived from patients or clinical settings.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable. Ground truth in this context typically refers to clinical diagnosis or outcome, which is not part of this non-clinical testing. The "ground truth" for these engineering tests would be the established engineering specifications and measurement standards.

4. Adjudication method for the test set

• Not applicable. Adjudication methods are typically used in clinical studies involving human interpretation or outcome assessment. These were objective engineering tests.

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

• Not applicable. This document pertains to a physical medical device (biliary stent and delivery system), not an AI algorithm. Therefore, MRMC studies or AI assistance are not relevant.

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

• Not applicable. See point 5. This is not an algorithmic device.

7. The type of ground truth used

• Engineering Specifications / Test Standards: The "ground truth" for the non-clinical tests would be the established engineering specifications, performance standards, and test methods designed to evaluate device integrity, functionality, and safety. The report states "Testing was conducted in accordance with the FDA Guidance for Metal Expandable Biliary Stents."

8. The sample size for the training set

• Not applicable. There is no "training set" in the context of this type of medical device submission. Training sets are relevant for machine learning or AI models.

9. How the ground truth for the training set was established

• Not applicable. See point 8.

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