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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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The Express™ Biliary LD Premounted Stent System is indicated for the palliation of malignant neoplasms in the biliary tree.

The 27 mm Express Biliary LD Premounted Stent System will be identical to the currently marketed Express Biliary LD Premounted Stent Systems (K021630). 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, after which 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 stent provides a ghost like image using conventional radiographic imaging equipment. The currently marketed Express Biliary LD Premounted Stent System is offered with stent diameters of 6 - 10 mm, in one mm increments. The 6 - 8 mm diameter stents has lengths of 17 mm, 37 mm, and 57 mm. The 27 mm length is proposed for these stent diameters and is the subject of this submission. These are considered to be the Small Lumen (SL) models. The 9 mm and 10 mm diameter stents have lengths of 25 mm. 37 mm, and 57 mm. These are considered to be the Large Lumen (LL) models. The balloon delivery catheter for the 27 mm Express Biliary LD Premounted Stent System will be identical to the one utilized on the currently marketed Express Biliary LD Premounted Stent Systems (K021630). The Balloon Delivery Catheter is an over-the-wire catheter offered in a two lumen catheter shaft design. One lumen is used to pass the catheter over a guide wire. The proposed device is designed to be placed over guide wires which have outer diameters of 0.035" or smaller. This lumen can also be used for infusion of contrast medium. The second lumen communicates with the balloon and is used to inflate and deflate the balloon during the stenting procedure. The guide wire lumen and the balloon lumen terminate at the proximal end of the catheter by means of a bifurcated hub with luer lock fittings.

This document describes the regulatory submission (K024048) for the Boston Scientific Express Biliary LD Premounted Stent System (27 mm). The submission asserts substantial equivalence to a previously marketed device (K021630) and does not contain detailed primary study data or explicit acceptance criteria with numerical performance targets and reported device performance.

Therefore, many of the requested sections regarding specific study details, such as sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment, cannot be extracted from the provided text.

Based on the provided text, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of numerical acceptance criteria with corresponding device performance metrics. Instead, it describes general functional testing and states that "Test results verified that the Express Biliary LD Premounted Stent System is adequate for its intended use."

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

• Sample Size for Test Set: Not specified.
• Data Provenance: Not specified. The document describes non-clinical (functional and biocompatibility) testing. It does not mention clinical data or human subject data.

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

• Number of Experts: Not applicable. The document describes non-clinical engineering and biological testing, not expert-derived ground truth from clinical cases.
• Qualifications of Experts: Not applicable.

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

• Adjudication Method: Not applicable. This concept applies to expert review of clinical cases. The testing described is objective, functional testing.

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:

• MRMC Study: No, an MRMC comparative effectiveness study was not done.
• Effect Size of AI Assistance: Not applicable, as this is not an AI-assisted device.

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

• Standalone Performance: Not applicable, as this is a medical device (stent system), not an algorithm.

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

• Ground Truth: For the non-clinical tests described, the "ground truth" would be established engineering specifications, material standards, and validated test methods (e.g., tensile strength, corrosion resistance, dimensional tolerances). There is no reference to expert consensus, pathology, or outcomes data for establishing ground truth in this non-clinical submission.

8. The sample size for the training set:

• Sample Size for Training Set: Not applicable. This is a medical device, not an AI model, so there is no concept of a "training set" in the context of machine learning.

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

• Ground Truth for Training Set: Not applicable.

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