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The Niti-S Biliary Speed D Stent is indicated for the palliation of malignant strictures in the biliary tree.

The Niti-S Biliary Speed D Stent consists of an implantable metallic stent and a disposable, flexible Stent Delivery System for placement of the stent is a flexible and expandable tubular device made of Nitinol wire. Two Nitinol wires are woven in a hook-type design. The stent design is identical to the predicate device cleared in K073667. The Stent Delivery System is a disposable system for the delivery and deployment of the stent at the target position.

The provided text is an FDA 510(k) clearance letter and summary for a medical device called the "Niti-S Biliary Speed D Stent." This document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than performing a de novo clinical study to establish performance against acceptance criteria for a novel AI/software medical device.

Therefore, the information required to populate a table of acceptance criteria and a detailed study proving device performance (especially for an AI/software product, as implied by questions like sample size for training data, expert consensus, MRMC studies, etc.) is not present in this document.

Specifically, the document states:

• "Software Verification and Validation Testing: Not applicable. The subject device contains no software of any type." (Page 8)
• "Animal Testing: Not applicable. Animal studies are not necessary to establish the substantial equivalence of this device." (Page 9)
• "Clinical Data: Not applicable. Clinical studies are not necessary to establish the substantial equivalence of this device." (Page 9)

The 510(k) pathway for this device relies primarily on:

• Identical Indications for Use
• Highly similar technological characteristics to a predicate device (Niti-S Biliary Stent, K073667).
• Non-clinical bench testing to confirm physical characteristics and performance (e.g., integrity, radial force, material properties) and biocompatibility testing for material changes in the delivery system.
• Sterilization and Shelf Life testing.

As such, I cannot provide the requested information about acceptance criteria and study details for an AI/software medical device based on this document. The document describes a physical medical device (stent and delivery system), not an AI or software product.

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