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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. 7 French stent delivery system profile; Stent material – Nickel Titanium alloy and tantalum micromarkers; Expanded stent diameters 12, and 14 mm; Stent lengths: 20, 30, 40, 60, and 80mm; Stent delivery system usable length 80 and 120 cm; Guidewire lumen 0.035" compatible; and Proximal Deployment handle

The provided text is a 510(k) summary for the SMART™ Control™ Nitinol Stent Transhepatic Biliary System. It does not describe a study involving device performance metrics, acceptance criteria, or ground truth establishment in the context of an AI/ML device.

Instead, it focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance. The document highlights the device's technical specifications, indications for use, and a comparison to existing, legally marketed stents.

Therefore, I cannot extract the requested information (acceptance criteria, reported performance, sample sizes, expert qualifications, adjudication methods, MRMC study details, standalone performance, training set information, or ground truth establishment methods) because this information is not present in the provided 510(k) summary.

The document only states:

• Study that proves the device meets acceptance criteria: "The equivalence was confirmed through pre-clinical testing." (Page 2, Summary of Substantial Equivalence). This refers to pre-clinical testing for biocompatibility and mechanical properties, not a clinical study involving specific performance metrics as might be seen for devices like diagnostic AI.

To elaborate on why each requested point cannot be answered:

1. A table of acceptance criteria and the reported device performance: Not present. The approval is based on substantial equivalence to predicate devices, not specific performance metrics against pre-defined acceptance criteria for a new type of device performance (e.g., diagnostic accuracy).
2. Sample size used for the test set and the data provenance: Not applicable to the presented pre-clinical testing for substantial equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for diagnostic performance is not established here.
4. Adjudication method: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No, this is not a diagnostic AI device, so MRMC studies are not relevant in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, this is a physical medical device (a stent), not an algorithm.
7. The type of ground truth used: For the pre-clinical testing mentioned, ground truth would relate to material properties, mechanical integrity, and biocompatibility, typically established through standardized in-vitro and in-vivo animal testing, not expert consensus on human data. Specifics are not provided beyond "pre-clinical testing."
8. The sample size for the training set: Not applicable; this is a physical device, not an AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

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