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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 6, 7, 8, 9, and10 mm; Stent lengths: 20, 30, 40, 60, 80, and 100 mm; Stent delivery system usable length 80 and 120 cm; and Guidewire lumen 0.035". Proximal Deployment Handle

The provided text is a 510(k) summary for a medical device (SMART™ Control™ Nitinol Stent Transhepatic Biliary System) and a letter from the FDA. It does not include information about acceptance criteria or a study proving device performance in the context of the requested details about AI/algorithm performance.

The document discusses:

• Device Name: SMART™ Control™ Nitinol Stent Transhepatic Biliary System
• Predicate Devices: SMART™ Control Nitinol Stent Transhepatic Biliary System (K021898 and K031777)
• Indications for Use: Palliation of malignant neoplasms in the biliary tree.
• Device Description: Stent material (Nickel Titanium alloy and tantalum micromarkers), stent dimensions (diameters, lengths), delivery system (French profile, usable length, guidewire lumen), and proximal deployment handle.
• Biocompatibility: Stated as biocompatible.
• Substantial Equivalence: Confirmed through pre-clinical testing, comparing it to predicate devices.
• FDA Communication: A letter affirming substantial equivalence but requiring specific warnings regarding use in the vascular system and prominent display of the biliary indication.

The document does not contain any information related to:

• Acceptance criteria in the context of an algorithm or AI.
• Reported device performance as would be detailed for an AI.
• Sample sizes for test sets, training sets, or data provenance for an AI study.
• Number of experts, their qualifications, or adjudication methods for ground truth establishment for an AI.
• MRMC comparative effectiveness studies or human reader improvement with AI.
• Standalone algorithm performance.
• Type of ground truth (e.g., pathology, outcomes data) for an AI.

Therefore, I cannot provide the requested table and study details as they pertain to AI/algorithm performance based on the given input. The "study" mentioned is "pre-clinical testing" used to establish substantial equivalence for a physical medical device, not an AI evaluation.

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