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The Bard® CONFORMEXX™ Biliary Stent and Delivery System is indicated for use in the treatment of biliary strictures resulting from malignant neoplasms.

The Bard® CONFORMEXX™ Biliary Stent and Delivery System is a stenting device designed to maintain the patency of biliary ducts obstructed by malignant neoplasms. The device includes the self-expanding Bard® CONFORMEXX™ Biliary Stent pre-loaded on a unique delivery system. The stent is available in a variety of diameters and lengths. The 6 Fr delivery system is compatible with a 6 Fr introducer and accepts a 0.018" to 0.035" guidewire. The delivery systems is 135cm in length. The Bard® CONFORMEXX™ Biliary Stent is a metal mesh stent constructed of nitinol. The nitinol tube is laser cut into a series of rhombi.

The provided document is a 510(k) summary for a medical device (Bard® CONFORMEXX™ Biliary Stent and Delivery System) and outlines its intended use and performance data compared to predicate devices. However, it does not contain the specific information required to complete the detailed table and answer all questions regarding acceptance criteria, study design, sample sizes, ground truth establishment, or expert involvement as typically expected for a detailed AI/ML study description.

This document is from 2003, predating widespread AI/ML integration into medical device approvals in the way described in your request. The "Performance Data" section primarily focuses on physical and functional characteristics of the stent and its delivery system, rather than diagnostic accuracy or effectiveness metrics that would be relevant to studies involving AI assistance or standalone performance evaluation against a ground truth.

Therefore, many of the requested fields cannot be populated from the provided text.

Here's an attempt to answer based only on the provided text, with clear indications where information is missing:

Acceptance Criteria and Device Performance Study

The provided document describes a 510(k) premarket notification for the Bard® CONFORMEXX™ Biliary Stent and Delivery System. The performance data presented focuses on the physical and functional characteristics of the stent and delivery system itself, rather than a diagnostic or predictive algorithm. Therefore, the "acceptance criteria" discussed are related to the stent's mechanical properties and ease of use, assessed by comparison to predicate devices, not statistical performance metrics against a ground truth as would be typical for an AI/ML-driven device.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample size: Not specified. The document refers to "test results" and "data" but does not quantify the number of stents, delivery systems, or test conditions used in the performance evaluations.
• Data provenance: Not specified. The studies appear to be laboratory or bench-top tests focused on the device's mechanical and material properties. There is no mention of human subject data, country of origin, or retrospective/prospective clinical studies for the performance data presented here.

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 "ground truth" for the performance data (e.g., whether a stent tracks easily, its expansion force, or corrosion resistance) would be determined by objective physical measurements and engineering standards, not expert consensus or clinical interpretation.
• Qualifications of experts: Not applicable.

4. Adjudication method for the test set

• Adjudication method: Not applicable. This type of physical performance testing does not typically involve adjudication in the sense of resolving discrepancies between expert interpretations.

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. The device is a physical medical implant (biliary stent) and its delivery system, not an AI-driven diagnostic or assistive tool for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant to this device.
• Effect size: Not applicable.

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

• Standalone study: No. This device is not an algorithm. Its performance is evaluated based on its physical characteristics and function.

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

• Type of ground truth: The "ground truth" for the described performance data is based on objective engineering and material science standards and measurements. For example, the expansion force would be measured against a specific target, and corrosion resistance would be evaluated against material science standards for bile compatibility. It is not based on expert consensus, pathology, or outcomes data, as these are not relevant to the described performance tests.

8. The sample size for the training set

• Sample size: Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

• Ground truth establishment: Not applicable. This device is not an AI/ML algorithm that requires a training set with established ground truth.

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