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The SMART™ Control™ Nitinol Stent Transhepatic Biliary System is intended for use in the palliation of malignant neoplasms in the biliary tree.

The device description of the proposed SMART™ Control™ Nitinol Stent Transhepatic Biliary System is as follows.
• 6 French stent delivery system profile;
• Stent material – Nickel Titanium alloy and tantalum micromarkers;
• Expanded stent diameters 9 and 10 mm;
• Stent lengths: 80 mm;
• Stent delivery system usable length 80 and 120 cm;
• Guidewire lumen 0.035";

The provided text describes a medical device, the SMART™ Control™ Nitinol Stent Transhepatic Biliary System, and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets specific acceptance criteria.

The document is a 510(k) summary and the FDA's response letter, which focuses on regulatory approval based on demonstrating substantial equivalence to existing legally marketed devices. This regulatory pathway typically relies on comparison to predicate devices, and often involves pre-clinical testing, rather than extensive clinical studies with specific performance acceptance criteria as would be seen for new clinical efficacy claims or performance validation.

Here's a breakdown of why this information is missing based on the input provided:

• No specific acceptance criteria are listed. The document states "Performance standards have not been established by the FDA under section 514 of the Food, Drug and Cosmetic Act."
• No detailed study is described that measures performance against acceptance criteria. The document states, "The equivalence was confirmed through pre-clinical testing," but does not detail the methodology, sample sizes, ground truth establishment, or specific results of this testing.

Therefore, I cannot fulfill your request for a table of acceptance criteria, device performance, study details (sample sizes, provenance, expert involvement, adjudication, MRMC, standalone performance, ground truth types), or training set information as this information is not present in the provided text.

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