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Niti-S Esophageal Non-covered Stent & Introducer is intended for maintaining luminal patency in esophageal structures caused by intrinsic and/or extrinsic malignant tumors.

Niti-S Esophageal Non-covered Stent & Introducer is a rigid, flexible, and expandable tubular device made of a self-expanding Nickel Titanium alloy (Nitinol) wire that is intended to be implanted to restore the structure and/or function of the esophagus. This device also includes a device delivery system for deployment. Upon deployment, the stent imparts an outward radial force on the luminal surface of the lumen to establish patency.

The provided 510(k) summary for the Niti-S Esophageal Non-covered Stent & Introducer does not contain information related to acceptance criteria, device performance, or any clinical studies (such as MRMC or standalone studies) that would typically be used to demonstrate these.

The document is a submission for a medical device's 510(k) clearance, which primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device. This process often relies on non-clinical (bench) testing, material comparisons, and design similarities rather than extensive clinical performance studies with specific acceptance criteria that would assess accuracy, sensitivity, or specificity.

Therefore, I cannot provide the requested information. The document explicitly states:

• "The Niti-S Esophageal Non-covered Stent & Introducer has the similar device characteristics as the predicate device. Material, design and use concepts are similar."
• "The Niti-S Esophageal Non-covered Stent & Introducer has been subjected to extensive safety, performance, and validations prior to release. Safety and performance tests have been further performed to ensure the devices comply with applicable industry and US regulations."

These statements indicate that tests were performed, but the results, specific acceptance criteria, or details of any clinical studies comparing performance against established metrics or human readers are not included in this summary. The 510(k) concludes with a statement of "substantial equivalence" to the predicate device, which is the primary finding required by the FDA for this type of submission.

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