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The ev3 ParaMount™ Mini Stent and Delivery System is intended as a palliative treatment for malignant neoplasms in the biliary tree.

The ParaMount™ Mini Stent is a balloon expandable stainless steel stent with an open lattice design. The stent is electropolished. The device is provided premounted on a balloon delivery catheter. Upon balloon inflation the crimped stent expands to conform to the duct inner luminal surface and retains the expanded state upon balloon deflation.

This document describes the regulatory approval for a medical device (a biliary stent) and does not contain information about an AI/ML device or its performance characteristics. Therefore, I cannot extract the requested information regarding acceptance criteria, study details, expert qualifications, or ground truth for an AI/ML system.

The provided text pertains to a Premarket Notification (510(k)) Summary for a traditional medical device, specifically the "ParaMount™ Mini Stent and Delivery System (Biliary Indication)". The summary states that the device was modified to provide increased radiopacity and that "Performance testing (bench) further supports a substantial equivalence claim."

The substantial equivalence claim is based on:

• Identical intended use
• Identical materials
• Identical technological characteristics
• Identical performance to a legally marketed predicate device.

The study mentioned is "Performance testing (bench)", which refers to non-clinical, laboratory-based tests. Such tests are common for physical devices to evaluate aspects like mechanical strength, durability, patency, and in this case, radiopacity.

Here's why the requested information cannot be provided from this text:

• AI/ML Device: The device described is a physical stent, not an AI/ML algorithm.
• Acceptance Criteria & Performance Table: While the device has performance characteristics, these are for a physical object (e.g., radiopacity, expansion diameter, material properties) and not reported in the format of AI metrics like sensitivity, specificity, or AUC against a ground truth. The "acceptance criteria" here refer to meeting the predicate device's performance in bench tests and demonstrating increased radiopacity.
• Sample Size (Test Set/Training Set), Data Provenance, Experts, Adjudication, MRMC, Standalone Performance, Ground Truth Type (for AI/ML): These concepts are entirely specific to clinical studies or validation of AI/ML systems and are not relevant or described for a physical medical device like a stent undergoing 510(k) clearance based on substantial equivalence and bench testing.

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