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Precise™ Nitinol Stent Transhepatic Biliary System (6F) is indicated for The use in the palliation of malignant neoplasms in the biliary tree.

The device description of the proposed Precise™ Nitinol Stent Transhepatic Biliary System (6F) is as follows.
• 5 / 6 French stent delivery system profile;
• Stent material – Nickel Titanium alloy;
• Expanded stent diameters 8, 9, and 10 mm;
• Stent lengths: 20, 30, and 40 mm;
• Stent delivery system usable length 135 cm; and
• Guidewire lumen 0.018".

The provided text is a 510(k) summary for a medical device called "Precise™ Nitinol Stent Transhepatic Biliary System (6F)". This document focuses on demonstrating substantial equivalence to a predicate device through preclinical testing and does not contain information regarding clinical studies, acceptance criteria, or performance metrics in the way typically required for AI/ML device evaluations.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving the device meets them from the given text.

The document primarily covers:

• Device Name: Precise™ Nitinol Stent Transhepatic Biliary System (6F)
• Predicate Device: Precise™ Nitinol Stent Transhepatic Biliary System (510(k) # K010445)
• Classification: Class II
• Indications for Use: Palliation of malignant neoplasms in the biliary tree.
• Device Description: Stent delivery system profile, stent material, expanded stent diameters, stent lengths, usable length, and guidewire lumen.
• Biocompatibility: Stated that all materials are biocompatible.
• Substantial Equivalence: Stated that equivalence was confirmed through "pre-clinical testing."

There is no mention of:

• Acceptance criteria for device performance.
• Any clinical study or performance study on humans or with AI/ML components.
• Sample sizes for test sets or training sets.
• Data provenance, expert ground truth, adjudication methods, or MRMC studies.
• Ground truth types.

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