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

The 5 mm Express Biliary LD Stent (Premounted Stent System and Unmounted Stent) are identical to the currently marketed Express Biliary LD Premounted Stent Systems (K021630 and K024048) and to the currently marketed Express Biliary LD Unmounted Stents (K030645), with the exception of size. The Express Biliary LD Stent is a balloon expandable 316L surgical grade stainless steel 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 provided text describes a 510(k) summary for the Boston Scientific Express Biliary LD Stent and explicitly states the device's substantial equivalence to predicate devices based on non-clinical testing. It does not contain information about acceptance criteria, device performance via a clinical study, sample sizes, expert involvement, adjudication methods, MRMC studies, or standalone algorithm performance. The information focuses on design, manufacturing, and intended use equivalence, referencing existing 510(k) applications for a detailed device description.

Therefore, I cannot fulfill your request for information regarding clinical study setup and results from the provided text. The document is a regulatory submission focused on demonstrating substantial equivalence through non-clinical means.

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

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 excellent radial strength while conforming to the natural curvature of the anatomy. The stent provides a ghost like image using conventional radiographic imaging equipment. The Express Biliary LD Stent will be offered in Small Vessel (SV) and Large Vessel (LV) models. The SV model will be used for vessel diameters ranging from 6 mm through 8 mm, with lengths of 17 mm, 37 mm, and 57 mm. The LV model will be used for vessel diameters of 9 mm and 10 mm with lengths of 25 mm, 37 mm, and 57 mm.

The Express Biliary LD balloon delivery catheter will be substantially equivalent to the legally marketed Boston Scientific Ultra-thin SDS Balloon Dilatation Catheter (K011889 and K011909). The delivery catheter is identical to the predicate catheter with the exception of one minor component and material change and one design change associated with the number of balloon folds. The hub utilized for the delivery catheter will be the hub design currently used on the Boston Scientific Synergy Balloon Dilatation Catheter (submitted under the name SC 35 Balloon Dilatation Catheter), cleared to market under K993303 and K993305. 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 guidewire. The proposed device is designed to be placed over guidewires 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 guidewire lumen and the balloon lumen terminate at the proximal end of the catheter by means of a bifurcated hub with luer lock fittings.

The provided document does not contain acceptance criteria for device performance in the traditional sense of a study with quantitative metrics and statistical analysis. Instead, it describes a 510(k) premarket notification for a medical device (Boston Scientific Express Biliary LD Premounted Stent System), which focuses on demonstrating substantial equivalence to a predicate device already on the market.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, expert involvement, and ground truth are not applicable to this type of regulatory submission.

However, I can extract information related to the non-clinical testing performed to establish this substantial equivalence.

Here's a breakdown of the available information:

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

The document does not provide a table of specific numerical acceptance criteria alongside quantifiable reported device performance in the typical scientific study format. Instead, it lists various functional tests and concludes that the test results "verified that the Express Biliary LD Premounted Stent System is adequate for its intended use and is considered substantially equivalent to the legally marketed Johnson & Johnson Corinthian IQ Transhepatic Biliary Stent with Delivery Catheter." Essentially, the "acceptance criteria" here implicitly mean passing these functional tests to demonstrate similar performance to the predicate device.

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

• Sample Size: The document does not specify the sample sizes (e.g., number of stents or catheters tested) for any of the functional or biocompatibility tests.
• Data Provenance: The tests are described as "Non-clinical Test Summary" and "in-vitro testing and evaluation." This indicates that the tests were conducted in a laboratory setting, likely by the manufacturer (Boston Scientific Corporation, One Scimed Place, Maple Grove, Minnesota), rather than involving human clinical data. Therefore, country of origin related to patient data, retrospective/prospective, are not applicable.

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)

• This information is not applicable as the tests described are functional and biocompatibility bench/in-vitro tests, not clinical evaluations requiring expert interpretation of patient data or images to establish a "ground truth" for a test set.

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

• This information is not applicable for the same reasons as point 3. These are non-clinical engineering and biological tests, not clinical studies with subjective evaluation that would require adjudication.

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

• An MRMC comparative effectiveness study was not done. This document describes a 510(k) submission for a physical medical device (stent system), not an AI/software 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, as the device is a physical medical stent system, not an algorithm.

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

• For the non-clinical tests, the "ground truth" would be established by objective, verifiable engineering and scientific standards (e.g., direct measurements of dimensions, standardized material property tests, established biocompatibility protocols). There's no "expert consensus" or "pathology" in the human diagnostic sense involved.

8. The sample size for the training set

• This is not applicable. There is no "training set" as this is not a machine learning or AI-based device. The device itself is what was tested.

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

• This is not applicable for the same reason as point 8.

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