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The X-Suit NIR® Biliary Metallic Stent is indicated for palliation of malignant strictures in the biliary tre.

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This document is a 510(k) premarket notification letter from the FDA for a medical device called the X-Suit NIR® Biliary Metallic Stent. It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment. This type of FDA letter is an approval for market, not a study report.

Therefore, I cannot provide the requested information from the given text. The document states "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent...". This means the device was found to be substantially equivalent to a legally marketed predicate device, rather than having specific performance criteria and studies detailed in this letter.

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