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The WallFlex Biliary Transhepatic Stent System is indicated for use in the palliative treatment of biliary strictures produced by malignant neoplasms.

The WallFlex™ Biliary Transhepatic Stent System is comprised of two components: the implantable WallFlex Biliary Transhepatic stent and the delivery system.

The stent is offered uncovered or covered. The covered stents are offered as fully covered, or partially covered with a Permalume™ stent covering. The stent wires have a radiopaque core to improve radiopacity.

The stent is preloaded onto the delivery system, which has radiopaque marker bands used to aid in imaging during deployment of the stent. The delivery system accommodates a 0.035 in (0.89 mm) guidewire.

Here's an analysis of the provided text regarding the WallFlex™ Biliary Transhepatic Stent System, focusing on acceptance criteria and supporting studies:

Acceptance Criteria and Device Performance for WallFlex™ Biliary Transhepatic Stent System

This device appears to be a medical stent system, and as such, the "acceptance criteria" and "device performance" are primarily focused on the physical and biological characteristics of the device itself, rather than diagnostic accuracy or algorithmic performance usually seen in AI/software devices. The study conducted is a demonstration of substantial equivalence to existing predicate devices through a combination of biocompatibility and performance bench testing.

1. Table of Acceptance Criteria and Reported Device Performance

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

Due to the nature of the device (a physical medical stent system) and the type of evaluation performed (bench testing for substantial equivalence), the concept of "test set sample size" and "data provenance" (country, retrospective/prospective) in the context of data-driven AI models does not directly apply here.

• The "test set" for biocompatibility comprised samples of the delivery system and relied on the stent component being identical to previously cleared devices. The exact number of samples for each biocompatibility test is not specified in the summary but would be standard for EN ISO 10993-1:2009.
• The "test set" for performance testing involved physical samples of the WallFlex™ Biliary Transhepatic Stent System. The exact number of units tested for each performance metric (deployment, reconstrainment, etc.) is not specified, but the summary states "comparative performance testing was successfully completed."
• There is no mention of country of origin for data or retrospective/prospective study design as this was a benchtop engineering and materials performance study.

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

This information is not applicable to this type of device submission. Ground truth, in the context of medical AI/software devices, refers to the definitive determination of a condition or diagnosis, often established by expert consensus or histological examination. For a physical stent system, the "truth" is whether the device meets its engineering and material specifications, which is determined by objective physical and chemical testing rather than expert interpretation of medical data.

4. Adjudication Method for the Test Set

Not applicable. The evaluation was based on objective physical and chemical testing, not subjective interpretation requiring adjudication of agreement between experts.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is not an AI/software diagnostic device, thus an MRMC study comparing human readers with and without AI assistance is irrelevant.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This is a physical medical device, not an algorithm.

7. Type of Ground Truth Used

The "ground truth" for this device's evaluation was based on:

• Established Biocompatibility Standards: EN ISO 10993-1:2009 for the delivery system materials.
• Engineering and Design Specifications: For the performance characteristics (deployment, reconstrainment, guidewire passage, trackability/pushability). The success of these tests is determined by adherence to predefined, objective performance criteria.
• Identity to Predicate Device Materials: For the stent component's biocompatibility, the ground truth was "identity to the current WallFlex Biliary RX Stent."

8. Sample Size for the Training Set

Not applicable. There is no training set in the context of an AI/machine learning model for this physical medical device. The "training" for such devices involves design, manufacturing, and R&D processes, not data-driven model training.

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

Not applicable, as there is no training set as understood in AI/ML contexts.

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