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The SMARTTM ControlTM 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 SMARTTM ControlTM 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

There is no information in the provided text about a study proving the device meets specific acceptance criteria in terms of performance metrics (like sensitivity, specificity, accuracy) that would typically be associated with AI/software devices. The document is a 510(k) summary for a medical device (a biliary stent), not an AI algorithm.

Here's a breakdown based on the categories requested, highlighting the lack of information pertinent to AI device studies:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not explicitly stated as performance metrics. The submission is a 510(k) for a physical medical device (stent), not a software/AI device. The "acceptance criteria" here are implicitly related to demonstrating substantial equivalence to predicate devices, primarily through pre-clinical testing for biocompatibility and mechanical properties.
• Reported Device Performance: The document states, "The SMART™ Control™ Nitinol Stent Transhepatic Biliary System is substantially equivalent to the predicate devices. The equivalence was confirmed through pre-clinical testing." No quantitative performance metrics (e.g., accuracy, sensitivity, specificity) are reported, as these are not relevant for this type of device submission.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable. This is a 510(k) for a physical medical device, not a data-driven AI device. There is no mention of a "test set" in the context of data. Pre-clinical testing would involve physical samples of the device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. There is no "ground truth" establishment in the context of data for an AI device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This is for a physical medical device (stent), not an AI assistance tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• Not applicable. There is no algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not applicable.

8. The sample size for the training set

• Not applicable.

9. How the ground truth for the training set was established

• Not applicable.

Summary of what the document does indicate:

• Device Type: SMART™ Control™ Nitinol Stent Transhepatic Biliary System (a biliary stent).
• Purpose of Submission: 510(k) for demonstrating substantial equivalence to predicate devices.
• Method of Proving Equivalence: Pre-clinical testing (likely mechanical, material, and biocompatibility testing) confirmed the device is substantially equivalent to predicate devices.
• Key Finding from FDA: The device is substantially equivalent, but a specific warning regarding unestablished safety and effectiveness for vascular use, and clear labeling for biliary use, is required.

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