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The SureSave™ Self-Expandable Biliary Nitinol Stent and Precision™ Stent Delivery Catheter is indicated for palliative treatment of biliary strictures produced by malignant neoplasms.
The SureSave " Self-Expandable Biliary Nitinol Stent and Precision" Stent Delivery Catheter is intended for use in the palliation of malignant neoplasms in the biliary tree.

The SureSave™ Self-Expandable Biliary Nitinol Stent and Precision™ Stent Delivery Catheter is comprised of two components; the implantable SureSave™ metallic stent and the Precision™ delivery system. The stent, provided pre-mounted on the delivery system, is a woven wire is constructed from a biomedical superalloy wire, braided in a tubular mesh configuration. The design configuration results in a stent that is flexible, compliant, self-expanding and can withstand strong radial force. The delivery system consists of an inner and outer catheter. The exterior catheter serves to constrain the stent until retracted during delivery. Radiopaque marker bands situated on the interior and exterior tubes aid in imaging during deployment. The inner catheter contains a central lumen which will accommodate a 0.018" guidewire.

The provided text describes a 510(k) submission for a medical device called the SureSave™ Self-Expandable Biliary Nitinol Stent and Precision™ Stent Delivery Catheter. This document is a regulatory approval letter from the FDA, not a detailed study report. As such, it does not contain the acceptance criteria or the specifics of a study that proves the device meets those criteria, nor any of the detailed information about sample sizes, ground truth establishment, or expert involvement that you requested.

The information provided is primarily focused on establishing substantial equivalence to predicate devices for regulatory clearance, rather than a clinical trial demonstrating performance against specific, quantifiable acceptance criteria.

Therefore, I cannot fulfill most of your request from the given text.

However, I can extract the following limited information:

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

This information is not available in the provided document. The document states: "The SureSave™ Self-Expandable Biliary Nitinol Stent and Precision™ Stent Delivery Catheter is substantially equivalent to the predicate devices. The equivalence was confirmed through preclinical testing." It does not provide specific performance metrics or acceptance criteria for that preclinical testing.

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

This information is not available in the provided document. The document mentions "preclinical testing" but does not specify sample sizes or data provenance.

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):

This information is not available in the provided document.

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

This information is not available in the provided document.

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:

This information is not applicable/available. The device is a physical stent and delivery system, not an AI-assisted diagnostic tool for human readers.

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

This information is not applicable/available. The device is a physical stent and delivery system, not an algorithm.

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

This information is not available in the provided document beyond the general statement of "preclinical testing" for substantial equivalence.

8. The sample size for the training set:

This information is not applicable/not available. The device is a physical medical device, not a machine learning model that requires a training set.

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

This information is not applicable/not available. The device is a physical medical device, not a machine learning model.

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