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The Express Biliary SD Premounted Stent System is available in the models indicated in Table 4.3. A brief description of the device components follows. The Express Biliary SD 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 SD stent is made from 316L surgical grade stainless steel. The stent geometry is a laser-cut pattern consisting of large and small sinusoidal bands connected by axial struts. Additional struts are provided to reinforce the three connector rows of the proximal stent end, resulting in additional scaffolding designed to reduce tumor in-growth at the proximal stent end. The delivery system for the Express Biliary SD Premounted Stent System consists of a Monorail™ catheter with a stent crimped on a balloon near the distal tip. The balloon is designed to provide an inflatable segment of known diameter and length at recommended pressures. The distal segment of the balloon catheter is dual lumen and coaxial. The outer lumen is used for inflation of the balloon. The wire lumen permits the use of guidewires (≤0.018 in / 0,46 mm) to facilitate advancement of the catheter to and through the stricture to be dilated.

AI/ML Overview

This document is a 510(k) Summary for the Boston Scientific Express Biliary SD Premounted Stent System. It primarily focuses on demonstrating substantial equivalence to a predicate device through a comparison of technological characteristics and non-clinical testing.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list "acceptance criteria" in a quantitative way with corresponding numerical performance results for the device. Instead, it outlines a series of non-clinical tests performed to demonstrate that the device functions as intended and is comparable to the predicate device. The implied acceptance criterion for each test is that the device performs acceptably and is substantially equivalent to the predicate.

Test Category	Specific Test	Implied Acceptance Criteria	Reported Device Performance
Stent Component Functional Testing	Bile corrosion resistance	Resists corrosion in a bile environment.	Not explicitly stated, but implied to be acceptable for intended use and comparable to predicate.
	Tensile and elongation	Sufficient strength and flexibility.	Not explicitly stated, but implied to be acceptable for intended use and comparable to predicate.
	Foreshortening	Maintains intended length upon deployment.	Not explicitly stated, but implied to be acceptable for intended use and comparable to predicate.
	Expanded stent length	Achieves specified length when expanded.	Not explicitly stated, but implied to be acceptable for intended use and comparable to predicate.
	Recoil	Minimal recoil after expansion to maintain patency.	Not explicitly stated, but implied to be acceptable for intended use and comparable to predicate.
	Expansion uniformity	Expands uniformly to desired diameter.	Not explicitly stated, but implied to be acceptable for intended use and comparable to predicate.
	Compression resistance/radial hoop strength	Sufficient radial strength to resist compression and maintain patency.	Not explicitly stated, but implied to be acceptable for intended use and comparable to predicate.
	Over-expansion	Tolerates some over-expansion without failure.	Not explicitly stated, but implied to be acceptable for intended use and comparable to predicate.
	Deployment pressure, accuracy and diameter	Deploys accurately at specified pressure to achieve desired diameter.	Not explicitly stated, but implied to be acceptable for intended use and comparable to predicate.
Delivery System Functional Testing	Repeat balloon inflation within a stent	Balloon can be inflated multiple times reliably.	Not explicitly stated, but implied to be acceptable for intended use and comparable to predicate.
	Balloon burst within the stent	Balloon withstands specified pressure without bursting prematurely.	Not explicitly stated, but implied to be acceptable for intended use and comparable to predicate.
	Balloon/delivery system distension and compliance	Balloon distends and complies as expected according to labeling.	Not explicitly stated, but implied to be acceptable for intended use and comparable to predicate.
	Balloon inflation and deflation time	Inflation and deflation times are within acceptable clinical parameters.	Not explicitly stated, but implied to be acceptable for intended use and comparable to predicate.
	Catheter tensile strength	Catheter possesses sufficient tensile strength for manipulation and withdrawal.	Not explicitly stated, but implied to be acceptable for intended use and comparable to predicate.
	Stent/balloon crossing profile	Maintains a low profile for navigability through anatomical structures.	Not explicitly stated, but implied to be acceptable for intended use and comparable to predicate.
	Stent securement force	Stent remains securely crimped until deployment.	Not explicitly stated, but implied to be acceptable for intended use and comparable to predicate.
Other Testing	Shelf life testing	Demonstrates acceptable results after 3 years of accelerated age testing.	Will be conducted and completed prior to commercialization. Implied to be acceptable to claim a 3-year shelf life.
	Biocompatibility Assessment	Materials are biocompatible and do not cause adverse reactions.	Not explicitly stated, but implied to be acceptable for intended use and comparable to predicate.

The Study that Proves the Device Meets Acceptance Criteria:

The "study" described in the document is a non-clinical (in-vitro) testing program designed to demonstrate substantial equivalence to a predicate device. The summary states: "Based on a comparison of intended use, design, and results of in-vitro testing, the Express Biliary SD Premounted Stent System is adequate for the intended use and is considered substantially equivalent to the legally marketed Johnson & Johnson Corinthian IQ Transhepatic Biliary Stent with Delivery Catheter."

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

Sample Size for Test Set: The document does not specify a numerical sample size for the "test set" in terms of how many devices or components were used for each non-clinical test. The testing appears to be based on engineering verification and validation of the device's physical and functional characteristics.
Data Provenance: The data provenance is non-clinical/in-vitro testing conducted by the manufacturer, Boston Scientific, Inc. No information regarding country of origin of the data or whether it was retrospective or prospective is applicable as it's not a clinical study.

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

This information is not applicable to this type of submission. The "ground truth" for non-clinical engineering tests is based on established engineering standards, specifications, and comparison to the predicate device's known characteristics, rather than expert consensus on diagnostic interpretations.

4. Adjudication Method for the Test Set

This is not applicable to the non-clinical testing described. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for interpreting medical images or clinical outcomes, which is not the nature of the testing described.

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, an MRMC comparative effectiveness study was not done. This is a 510(k) submission for a medical device (stent and delivery system), not an AI/ CAD (Computer-Aided Detection/Diagnosis) software. Therefore, the concept of human readers improving with or without AI assistance is irrelevant here.

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

No, this is not applicable. This device is a physical medical device (stent and delivery system), not an algorithm or software.

7. The Type of Ground Truth Used

For the non-clinical testing, the "ground truth" is based on engineering specifications, design requirements, and comparison to the characteristics of the legally marketed predicate device.
- For example, for "expanded stent length," the ground truth would be the specified design length. For "compression resistance," it would be the required radial force. For biocompatibility, it would be compliance with ISO standards for medical device materials.

8. The Sample Size for the Training Set

This is not applicable as this is a physical medical device, not a machine learning or AI model. Therefore, there is no "training set."

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

This is not applicable for the same reason as above (no training set for a physical medical device).

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