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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.

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