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The Cordis S.M.A.R.T.™ Nitinol Stent Transhepatic Biliary System - 40 cm is intended for use in the palliation of malignant neoplasms in the biliary tree.

7 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, 40, 60, and 80 mm; ● Stent delivery system usable length 40 cm; and . Guidewire lumen 0.035".

The provided text describes a 510(k) submission for the Cordis S.M.A.R.T.™ Nitinol Stent Transhepatic Biliary System - 40 cm. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical trials to establish de novo performance or acceptance criteria.

Therefore, the document does NOT contain information on:

• Acceptance criteria and reported device performance in a table format, as this is typically established through clinical performance studies.
• Sample size and data provenance for a test set.
• Number of experts and their qualifications for establishing ground truth.
• Adjudication method.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness study or its effect size.
• Standalone algorithm performance.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

Instead, the document states:

1. Acceptance Criteria and Study:

• Acceptance Criteria: Not explicitly stated as a set of performance metrics. The underlying "acceptance criteria" for a 510(k) submission is demonstrating substantial equivalence to a predicate device.
• Study Proving Equivalence: The document states, "The Cordis SMART™ Nitinol Stent Transhepatic Biliary System - 40 cm is substantially equivalent to the predicate device. The equivalence was confirmed through pre-clinical testing."

Summary of Device Performance (as demonstrated by substantial equivalence):

The device is considered to perform equivalently to the predicate device Cordis SMART™ Nitinol Stent Transhepatic Biliary System (510(k) # K001843 - July 18, 2000) for its intended use.

Detailed Breakdown of what is NOT available from the provided text:

Due to the nature of a 510(k) submission, particularly for a Biliary Stent, the provided text focuses on demonstrating substantial equivalence, not on establishing novel performance metrics through a clinical study with detailed acceptance criteria and expert-adjudicated ground truth.

1. A table of acceptance criteria and the reported device performance: Not provided. The submission relies on pre-clinical testing to confirm substantial equivalence to a predicate device, rather than establishing new performance metrics.
2. Sample size used for the test set and the data provenance: Not applicable or provided, as there is no mention of a clinical test set in the context of efficacy or diagnostic performance. The substantial equivalence was confirmed via pre-clinical testing, which would involve laboratory or bench tests, not patient data in the sense of a clinical test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable or provided. Ground truth in this context (for a medical device like a stent) would typically refer to outcomes in clinical trials, which are not detailed here. The "ground truth" for the 510(k) is the established safety and effectiveness of the predicate device.
4. Adjudication method for the test set: Not applicable or provided.
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 device is a stent, not an AI-powered diagnostic tool requiring human reader studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a stent, not a software algorithm.
7. The type of ground truth used: For a device like a stent, "ground truth" for regulatory purposes typically relates to objective measures of safety (e.g., biocompatibility, mechanical integrity) and performance (e.g., ability to expand and maintain patency). These were assessed via pre-clinical testing for substantial equivalence. The "intended use" (palliation of malignant neoplasms in the biliary tree) implies clinical outcomes, but no clinical study results are presented here.
8. The sample size for the training set: Not applicable. There is no mention of an algorithm or training set.
9. How the ground truth for the training set was established: Not applicable.

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