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Ultraflex™ Esophageal NG Stent System (covered) is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors only, and occlusion of concurrent esophageal fistula.

The proposed Ultraflex Esophageal NG Stent System allows for the placement of a selfexpanding metallic stent within the esophagus. The systems consist of a flexible delivery catheter preloaded with an expandable stent. The stent is offered covered with either a proximal release or distal release delivery system. The stent may be placed fluoroscopically using radiopaque markers as a guide or endoscopically using the visual marker on the delivery catheter. The proposed device incorporates a material formulation change for the stent covering and covering adhesive material.

The provided text does not contain information about acceptance criteria and a study proving a device meets them in the context of an AI/ML-based medical device. Instead, the document describes a 510(k) summary for a medical device called the "Ultraflex™ Esophageal NG Stent System."

This submission is a Special 510(k) Premarket Notification for a device that is substantially equivalent to a previously cleared device. The key difference in the proposed device is a material formulation change for the stent covering and covering adhesive material.

Therefore, the "performance data" section focuses on in-vitro testing to demonstrate that this material change does not negatively impact the device's performance. There is no mention of an AI/ML component, diagnostic performance metrics (like sensitivity, specificity, accuracy), or any studies involving human readers or ground truth establishment relevant to AI.

Here's why the requested information cannot be extracted:

• No AI/ML Component: The device is a physical medical implant (stent) and does not involve artificial intelligence or machine learning for diagnostic or assistive purposes.
• Performance Data Type: The "Performance Data" mentioned (dimensional, tensile strength, integrity, exposure resistance, chemical analysis, and biocompatibility) are typical for material changes in medical devices, not for evaluating AI algorithms.
• Comparison to Predicate: The entire submission is built on demonstrating substantial equivalence to a legally marketed predicate device, primarily through in-vitro testing for the material change.

Therefore, I cannot provide the requested table and details because the provided input document describes a traditional medical device submission (a stent with a material change), not an AI/ML device.

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