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The Boston Scientific Express™ Biliary LD Unmounted Stent is indicated for use in the palliation of malignant neoplasms in the biliary tree.

The Express Biliary LD Unmounted Stent will be the identical stent that is currently marketed as the Express Biliary LD Premounted Stent System (K021630 and K024048). The stent will be hand mounted by the user upon its recommended balloon delivery catheter.

The Express Biliary LD Stent is a balloon expandable metallic stent intended to maintain patency of biliary strictures produced by malignant neoplasms. The stent will be available in a variety of sizes to address clinician needs.

The Express Biliary LD Stent is made from 316L surgical grade stainless steel tubing. The seamless tubing is initially extruded to a cylindrical shape, and is then drawn down in a series of steps to the final tubing dimension. The stent is formed by laser cutting the pattern from the tube, then it is cleaned and electropolished to obtain smooth rounded struts.

The geometry is a continuous pattern consisting of large and small sinusoidal bands connected by axial struts. The deployed stent provides radial strength while conforming to the natural curvature of the anatomy.

The Express Biliary LD Stent will be offered in Small Lumen (SL) and Large Lumen (LL) models. The SL model will be offered in lengths of 17 mm, 27 mm, 37 mm, and 57 mm and is designed to expand from 6 mm to 8 mm in diameter. The LL model will be offered in lengths of 25 mm, 37 mm, and 57 mm and is designed to expand from 9 mm to 10 mm in diameter. They are the identical stent sizes in which the Express Biliary LD Premounted Stent System is offered.

The provided text describes the Boston Scientific Express Biliary LD Unmounted Stent. However, it does not contain specific acceptance criteria, reported device performance metrics (e.g., sensitivity, specificity, accuracy), or details of a study involving human readers or AI assistance. The document focuses on establishing substantial equivalence to a predicate device through non-clinical testing.

Therefore, many of the requested sections cannot be filled from the provided text.

Here's a breakdown of what can be extracted and what is missing:

The device described is the Boston Scientific Express Biliary LD Unmounted Stent, indicated for the palliation of malignant neoplasms in the biliary tree.

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

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not applicable. The document describes non-clinical design verification tests and analyses, not a clinical study involving human or AI interpretation of a test set.
• Data Provenance: Not applicable. The tests are non-clinical (biocompatibility, product and packaging shelf life testing).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable. No experts were used for ground truth establishment as it was a non-clinical evaluation.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. There was no test set requiring adjudication in the context of human or AI performance.

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, and therefore, no effect size for human readers with and without AI assistance is reported. This submission is for a medical device (a stent), not an AI diagnostic tool.

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

Not applicable. This device is a physical medical stent, not an algorithm, so standalone algorithm performance is not relevant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable in the context of diagnostic accuracy. The ground truth for the non-clinical tests would be based on engineering specifications, material standards, and validated laboratory methodologies for biocompatibility and shelf-life testing.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI model, so there is no training set.

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

Not applicable. As there is no training set for an AI model.

Summary of the study that proves the device meets the acceptance criteria (based on the provided text):

The device (Express Biliary LD Unmounted Stent) received clearance based on non-clinical design verification tests and comparative analysis to a predicate device. The key arguments for demonstrating safety and effectiveness were:

• Identical Stent: The Express Biliary LD Unmounted Stent is stated to be the "identical stent that is currently marketed as the Express Biliary LD Premounted Stent System (K021630 and K024048)."
• Identical Design and Technology: It incorporates the "identical design, method of deployment, fundamental technology, manufacturing, sterilization, and intended use" as the predicate device.
• Identical Sizes: The available stent sizes (SL and LL models with various lengths and diameters) are identical to those offered in the premounted system.
• Non-Clinical Testing: "Biocompatibility, product and packaging shelf life testing have also been conducted." The results "verified that the Express Biliary LD Unmounted Stent is adequate for its intended use."

The entire submission is essentially a declaration of substantial equivalence to existing, legally marketed predicate devices, supported by non-clinical testing demonstrating that the unmounted version performs equivalently to the premounted version, with the primary difference being user-mounting onto a recommended, existing delivery catheter. There is no mention of clinical trials or performance evaluations involving human readers or AI.

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