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For use in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors.

The Esophageal TTS Stent consists of an implantable metallic stent and a flexible introducer system. The stent is a flexible, expandable tubular device made of Nitinol wire and covered with silicone. This device also includes a disposable introducer. Upon deployment, the stent imparts an outward radial force on the luminal surface esophagus to establish patency.

This document describes the premarket notification (510(k)) for the Taewoong Medical Esophageal TTS Stent. However, it does not contain information about the acceptance criteria and a study proving the device meets those criteria in the context of an AI/ML powered medical device. The information provided is for a traditional medical device (esophageal stent).

Therefore, I cannot fulfill your request as it pertains to AI/ML device performance and testing. The document focuses on the substantial equivalence of the Esophageal TTS Stent to previously cleared predicate devices based on physical and mechanical properties, not on an algorithm's performance.

Here's why I cannot provide the requested information from the given text:

• No AI/ML Component: The device described, the Esophageal TTS Stent, is an implantable metallic stent. It does not appear to have any artificial intelligence or machine learning components.
• Performance Data Type: The "Performance Data" section lists physical and mechanical tests like Deployment Testing, Expansion Force Testing, Compression Force Testing, Dimensional Testing, Tensile Strength Testing, Packaging Adhesive Testing, and MR Compatibility. These are standard tests for physical medical devices and do not involve evaluating an algorithm's accuracy, sensitivity, or specificity.
• Absence of Specific Metrics: There are no mentions of metrics like sensitivity, specificity, AUC, F1-score, or any other performance indicators typically associated with AI/ML devices.
• No Reference to Ground Truth or Expert Adjudication: The concept of "ground truth," expert consensus, or adjudication methods is irrelevant for the type of device and testing described in this document.

In summary, the provided text describes a medical device clearance process for a physical esophageal stent and does not contain the information requested about acceptance criteria and studies for an AI/ML-powered device.

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