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The NIR Biliary Stent is indicated for use in the treatment of biliary strictures produced by malignant neoplasms.

The proposed NIR™ Biliary Stent is a balloon expandable stent designed to be used with a balloon dilatation catheter. The delivery catheter facilitates transhepatic access to the biliary tree and the stent is designed to maintain luminal patency of biliary strictures produced by malignant neoplasms.

The provided text describes a medical device, the NIR™ Biliary Stent, and its FDA clearance (K973174). However, it does not contain information related to acceptance criteria, device performance metrics, or a study evaluating the device against such criteria.

The document details:

• The device's name and manufacturer.
• Its classification and predicate devices.
• A brief description of its intended use (maintaining luminal patency of biliary strictures produced by malignant neoplasms).
• A general statement about safety and performance, mentioning "Functional and integrity bench testing and Biocompatibility testing" were performed and supported substantial equivalence.

Therefore, I cannot fulfill your request for information regarding acceptance criteria and a study proving the device meets them from the provided text. The document states that "data supported the substantial equivalence of the NIRTM Biliary Stent to the predicate devices," but it does not elaborate on what that data was, what the acceptance criteria were, or the specifics of any studies.

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