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This device is used in palliation of malignant neoplasms in the biliary tree.

Stent Description: This flexible, self-expanding stent is constructed of nitinol wire with a radiopaque core. Both ends of the stent have an increased diameter called flanges intended to provide resistance to migration. The total length of the stent in its collapsed state is indicated by radiopaque markers on the inner catheter assembly. The stent is provided in either of two body diameters 8mm or 10mm and in the following lengths 4, 6, 8 or 10cm.

Stent Delivery System Description: The stent is mounted on an inner catheter, which accepts a 0.035" wire guide and is constrained by an outer sheath. A pistol-grip delivery handle allows stent deployment or recapture. The introducer sheath diameter is 8.5Fr and the working length is 200cm.

The provided text describes the Cook Ireland Evolution® Biliary Stent System. Here's an analysis of the provided information concerning acceptance criteria and supporting studies, formatted as per your request:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document refers to "Performance (bench) testing" which was "successfully completed." However, it does not specify the sample size used for the test sets for any of the individual bench tests (deployment, expansion force, etc.).

The data provenance is laboratory bench testing, presumably conducted by or for Cook Ireland Ltd. The country of origin for the data is not explicitly stated beyond Cook Ireland Ltd.'s address in Limerick, Ireland. The study is a retrospective evaluation of device characteristics against pre-defined engineering and regulatory standards, rather than a prospective clinical trial.

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

This information is not provided in the document. Bench testing typically relies on engineers and technicians to execute tests and interpret results against established specifications, rather than clinical experts establishing a "ground truth" in the same way it would be done for diagnostic AI.

4. Adjudication Method for the Test Set

This information is not provided. Bench testing is usually less about adjudication and more about objective measurements against pre-defined pass/fail criteria.

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, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This device is a physical medical device (a stent and its delivery system), not an AI algorithm. Therefore, the concept of human readers improving with or without AI assistance is not applicable.

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

No, a standalone performance study in the context of an algorithm or AI was not done. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

For the bench testing, the "ground truth" was established by predetermined technical specifications, engineering standards (e.g., ASTM standards), and regulatory guidance (FDA's Guidance for the Content of Premarket Notifications for Metal Expandable Biliary Stents). The device's performance was measured against these objective, quantitative criteria.

8. The Sample Size for the Training Set

This information is not applicable/not provided. There is no mention of a "training set" as this is a physical medical device and not an AI/machine learning model.

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

This information is not applicable/not provided for the same reason as point 8.

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The WallFlex™ Biliary RX Stent System Uncovered, WallFlex™ Biliary RX Stent System Partially Covered, and WallFlex™ Biliary RX Stent System Fully Covered are indicated for use in the palliative treatment of biliary strictures produced by malignant neoplasms.

The WallFlex™ Biliary RX Stent System Uncovered, WallFlex™ Biliary RX Stent System Partially Covered, and WallFlex 114 Biliary RX Stent System Fully Covered consist of a flexible delivery system preloaded with a self-expanding biliary metal stent.

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.

The provided text is a 510(k) summary for the WallFlex™ Biliary RX Stent System, which is a medical device. This document does not describe the acceptance criteria and a study proving a device meets those criteria in the context of an Artificial Intelligence (AI) or software-as-a-medical-device (SaMD) study.

Instead, this document focuses on the substantial equivalence of the WallFlex™ Biliary RX Stent System to its predicate devices for a specific labeling claim regarding MR Conditional safety and compatibility. The performance data mentioned is for in-vitro testing on the biliary metal stent, which is typical for hardware medical devices, not AI/SaMD.

Therefore, I cannot extract the requested information (acceptance criteria, device performance, sample sizes for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or ground truth types) because the provided text does not describe an AI/SaMD study. It's a regulatory submission for a physical medical device.

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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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