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The Cook Zilver® 635" Biliary Stent is indicated for use in palliation of malignant neoplasms in the biliary tree.
The Zilver® 635" Biliary Stent System is intended for palliation of malignant strictures in the biliary tree.

The Zilver® 635" Biliary Stent is a self-expanding, nitinol stent designed for excellent radial strength and optimal longitudinal flexibility. Constructed from a series of interconnected Z-shaped segments, the stent conforms to the shape of the biliary system and provides circumferential scaffolding throughout the stent's length. Gold radiopaque marker at the distal end of the delivery system, allow precise positioning of the stent's interconnected Z-shaped segments also keep foreshortening to a minimum.

The Zilver® 635" Biliary Stent comes preloaded in a 6 French delivery system. The stent is deployed with the use of a simple hand held device. The stent is available in unrestrained outer diameters of 4, 5, 6, 7, 8, 9 and 10 mm and in lengths of 20, 30, 40, 50, 60 and 80 mm. The 100, 120, and 140 mm length stents are an addition to this product line.

The provided text is a 510(k) summary for a medical device (Zilver® 635™ Biliary Stent System), not an AI/ML device. Therefore, it does not contain information related to acceptance criteria, device performance metrics (like sensitivity, specificity, AUC), sample sizes for test/training sets, expert qualifications, or ground truth establishment relevant to an AI/ML study.

The document discusses the substantial equivalence of the Zilver® 635™ Biliary Stent to predicate devices based on intended use, materials, and technological characteristics. It also details physical tests performed on the device to ensure reliable design and performance.

Here's an attempt to answer the questions based on the physical device testing mentioned, acknowledging that it's not an AI/ML study:

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

The document does not explicitly list quantitative acceptance criteria in a table format. It states that the device was subjected to tests "to assure reliable design and performance under the specified testing parameters." The "results of these 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." This implies that the device met the unstated acceptance criteria for each test.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample sizes (number of stents) used for each physical test. It only mentions "The Zilver® 635" Biliary Stent was subjected to the following tests..." This is typical for physical device testing where a sufficient number of units are tested to demonstrate consistency and compliance.

The data provenance is internal to Cook Incorporated, likely conducted in their facilities in the USA. These would be prospective physical tests, not data from patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This question is not applicable to the provided document. Ground truth, in the context of AI/ML, refers to labels derived from expert review of patient data. Here, the "ground truth" would be the engineering specifications and performance requirements for the physical stent, established by Cook's engineering and quality teams, not by medical experts reviewing patient data.

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

Not applicable. Adjudication methods are used in clinical studies or expert review of data. These were physical engineering tests, where results are measured against predefined specifications, not adjudicated by a panel.

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

Not applicable. This is not an AI/ML device, and no MRMC study was conducted.

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

Not applicable. This is not an AI/ML device.

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

The "ground truth" for these physical tests would be the engineering specifications and performance requirements set for the device. For example, a stent must deploy within a certain profile, have a specific radial force, and maintain integrity. These are not derived from expert consensus on medical images, pathology, or patient outcomes, but from design documents and industry standards for medical devices.

8. The sample size for the training set

Not applicable. There is no AI/ML model, and thus no training set.

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

Not applicable. There is no AI/ML model, and thus no ground truth for a training set.

In summary: The provided 510(k) summary is for a physical medical device (a stent) and details physical performance tests against design specifications, not an AI/ML system's diagnostic or predictive performance. Therefore, most of the requested information regarding AI/ML study design and metrics is not present in the document.

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The Cook Zilver® 635™ Biliary Stent is indicated for use in palliation of malignant neoplasms in the biliary tree.

The Zilver® 635™ Biliary Stent is a self-expanding, nitinol stent designed for excellent radial strength and optimal longitudinal flexibility. Constructed from a series of interconnected Z-shaped segments, 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® 635™ Biliary Stent, along with one radiopaque marker at the distal end of the delivery system, allow precise positioning of the stent. The stent's interconnected Z-shaped segments also keep foreshortening to a minimum. The Zilver® 635" Biliary Stent comes preloaded in a 6 French delivery system. The stent is deployed with the use of a simple hand held device. The stent is available in unrestrained outer diameters of 4, 5, 6, 7, 8, 9 and 10 mm and in lengths of 20, 30, 40, 50, 60 mm. The 80 mm length stent is an addition to this product line.

This is a
510(k) premarket notification for a medical device, not an AI/ML device. The provided text is a summary of the device, its predicate devices, and the tests performed to assure its design and performance. There is no mention of acceptance criteria related to AI/ML performance metrics, studies involving human readers, or ground truth establishment for AI model training. Therefore, I cannot generate the requested information about acceptance criteria and study details for an AI/ML device.

The document discusses "Test Data" for the Zilver® 635™ Biliary Stent, which includes:

• Deployment
  • Profile
  • Deployment Accuracy
  • Stent length and Change due to Deployment
  • Stent Diameter
  • Uniformity of Expansion
  • Stent Integrity

However, these are performance tests for a physical medical device (a biliary stent), not a study assessing the performance of an AI/ML algorithm.

Ask a specific question about this device