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The Cook ® Zilver™ Biliary Stent is indicated for use in palliation of malignant neoplasms in the biliary tree.

The Cook® Zilver™ Biliary Stent is a self-expanding, nitonol stent designed for superior radial strength and optimal longitudinal flexibility. Constructed from a series of interconnected Z-shaped seqments, the stent conforms to the shape of the biliary system and provides circumferential scaffolding throughout the stent's length. Gold radiopaque markers on each end of the Zilver™ Biliary Stent, along with radiopaque markers on the delivery system, allow precise positioning of the stent. The stent's interconnected Z-shaped segments also keep foreshortening to a minimum.

The Zilver™ Biliary Stent comes preloaded in a 7.0 Fr. (OD) sheath delivery system. The stent is deployed with the use of a simple hand held device. The stent is being made available in unrestrained outer diameters of 12 and 14mm's and in the lengths of 25, 30, 40, 50, 60 and 80mm's

Here's an analysis of the provided text regarding the acceptance criteria and study for the Cook® Zilver™ Biliary Stent:

1. Table of Acceptance Criteria and Reported Device Performance:

The document provides a list of tests conducted but does not explicitly state specific acceptance criteria (e.g., "stent must deploy within X seconds" or "radial force must be Y Newtons") or quantitative reported device performance values. Instead, it broadly states that the tests provide "reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a biliary stent."

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

• Sample Size: The document does not specify the sample size used for any of the tests.
• Data Provenance: The document does not provide information on the country of origin of the data or whether the tests were retrospective or prospective. Given the nature of a 510(k) summary, these are likely in-house laboratory and engineering tests rather than clinical studies with human patient data.

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 the type of testing described in the document. The tests performed are engineering and design verification tests, not clinical studies requiring expert consensus on ground truth. Ground truth in this context would be physical measurements and engineering specifications.

4. Adjudication Method for the Test Set:

This information is not applicable as there is no mention of a human-reviewed test set or "adjudication" in the clinical sense. The tests are physical and analytical.

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:

This is not applicable. The device described is a medical stent, not an AI or imaging diagnostic device that would involve human readers or AI assistance.

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

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

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for the tests described would be the engineering specifications and design requirements for the stent. For example, the specified diameter of the stent, its intended deployment accuracy, and its required structural integrity. The tests verify that the physical device meets these predefined engineering standards.

8. The Sample Size for the Training Set:

This is not applicable as there is no "training set" in the context of this physical device's testing. Training sets are relevant for machine learning models.

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

This is not applicable for the reasons stated above.

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The Wilson-Cook Modified Zilver Biliary Stent is indicated for use in palliation of malignant neoplasms in the biliary tree.
Used to maintain patency of malignant biliary strictures.
The Wilson-Cook Zilver Biliary Stent is indicated for use in the palliation of malignant neoplasms in the biliary tree.

The Wilson-Cook Modified Zilver Biliary Stent is indicated for use in palliation of malignant neoplasms in the biliary tree. This device and its introduction system are supplied sterile and intended for single use only.
The modification of the Zilver Biliary Stent includes a change to the introduction system only. The stent itself is identical to the predicate Cook Zilver Biliary Stent (K010242) in configuration and materials of construction, and the intended use for both the predicate and modified device are also the same. However, since the predicate introduction system is utilized for percutaneous biliary stent placement and the modified Wilson-Cook Metal Biliary Stent introduction system is used for endoscopic placement, the introduction system of the modified device is longer (200 cm) than that of the predicate device (80 cm).
These devices also operate in the same manner; the main difference being the method utilized in order to gain access to the placement site. The predicate device is used for percutaneous placement, while the modified Wilson-Cook Biliary Stent is placed endoscopically.

The document provided is a 510(k) summary for the Wilson-Cook Modified Zilver Biliary Stent. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, this document does not contain the detailed information necessary to fully address all aspects of your request regarding acceptance criteria and the study that proves the device meets those criteria.

Specifically, the document states:

• "All results obtained during our Design Verification met our predetermined acceptance criteria for this product line." (Page 2, "Design Control/Risk Analysis/Design Verification" section).
• It also mentions "dimensional and functional testing to ensure the performance and design integrity of this product line."

However, the document DOES NOT provide:

• The actual acceptance criteria themselves (the specific numerical or qualitative targets).
• The detailed results of these tests.
• Information about sample sizes, data provenance, ground truth establishment, expert qualifications, or adjudication methods for these tests.
• Any information regarding a multi-reader multi-case (MRMC) comparative effectiveness study or a standalone algorithm performance study, as this is a medical device, not an AI/software device.

Given the information provided in the 510(k) summary:

1. A table of acceptance criteria and the reported device performance:

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

• Sample Size for Test Set: Not specified in the document.
• Data Provenance: Not specified in the document. The tests seem to be internal design verification and functional testing conducted by the manufacturer, Wilson-Cook Medical Inc.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This type of information is generally not applicable to a physical medical device's design verification and functional testing, which relies on engineering specifications and laboratory measurements, not expert review of images or data. Therefore, this information is not present in the document.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not applicable as this is a physical medical device, not an AI/software device requiring human adjudication for test set ground truth.

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. This is a physical medical device (biliary stent and introducer), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study related to AI assistance is not applicable and was not performed.

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

• No. This is a physical medical device. This type of study is not applicable.

7. The type of ground truth used:

• For the device's design verification and functional testing, the "ground truth" would be established by the engineering specifications and performance requirements defined by the manufacturer based on regulatory standards, industry best practices, and the intended use of the device. Biocompatibility was established through "history of use in similar patient-contacting medical devices and as applicable biocompatibility test results."

8. The sample size for the training set:

• Not applicable. This is a physical medical device, not a machine learning algorithm.

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

• Not applicable. This is a physical medical device, not a machine learning algorithm.

In summary, the provided 510(k) indicates that design verification and functional testing were performed and met pre-determined acceptance criteria. However, it does not detail those criteria or the specifics of the testing as would be expected for an AI/software device. The questions related to experts, adjudication, MRMC studies, and training/test sets for AI are not applicable to this type of medical device submission.

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