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The Bard® E• LUMINEXX™ Biliary Stent is intended for palliation of malignant strictures in the biliary tree.

The proposed device is indicated for the treatment of biliary strictures resulting from malignant neoplasms.

The Bard® E+LUMINEXX™ Biliary Stent is a stenting device designed to maintain the patency of biliary ducts obstructed by malignant neoplasms. The device includes the self-expanding nitinol E▪LUMINEXX™ Stent preloaded on a flexible, multifunctional stent deployment system, the BARD S.A.F.E.TM Delivery System with the PerforMAXX™ Grip. It is preloaded into the delivery system and is available in two delivery system lengths, and various device diameters and lengths.

The Bard® E•LUMINEXX™ Biliary Stent is a modified version of the predicate LUMINEXX® 3 Biliary Stent. The modification is an electropolished surface finish, which is claimed to result in an improved surface finish, smoother edges, and improved corrosion resistance. The study conducted to demonstrate the device meets acceptance criteria is a non-clinical performance data verification and validation study.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a specific table of quantitative acceptance criteria for device performance. Instead, it states a general conclusion:

The acceptance criteria are generally framed around demonstrating substantial equivalence to the predicate device through non-clinical performance testing.

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

The document describes non-clinical performance data verification and validation. This indicates laboratory testing, not human subject testing. Therefore, there is no "test set" in the context of patient data, no country of origin for such data, and it is not retrospective or prospective patient data. The sample size would refer to the number of devices or components tested in the laboratory during design verification and validation, which is not specified in the provided text.

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

This question is not applicable. Ground truth, in the context of medical devices, usually refers to clinical outcomes or definitive diagnostic standards. Since the study was non-clinical performance testing, there were no experts establishing ground truth for a clinical test set.

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods are relevant for studies involving human interpretation or clinical endpoints, neither of which are described here for a non-clinical performance study.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The study described is a non-clinical performance verification and validation study comparing the modified device to its predicate.

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

This question is not applicable as the device is a physical biliary stent, not a software algorithm.

7. The Type of Ground Truth Used

For the non-clinical performance data, the "ground truth" would be established by engineering specifications, industry standards, and the performance characteristics of the predicate device. The tests were designed to confirm that the modified device's performance aligns with these established benchmarks for safety and effectiveness.

8. The Sample Size for the Training Set

This question is not applicable. There is no training set in the context of machine learning algorithms for this physical medical device. If "training set" refers to samples used during the development of the stent or its manufacturing process, that information is not provided.

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

This question is not applicable for the same reasons as #8.

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