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The balloon-expandable PERFLEX Stainless Steel Stent; .
A delivery balloon catheter (either the Cordis PowerFlex or OPTA 5 Balloon . Catheter, depending on the stent size); and,
. An insertion tool.

The Cordis PERFLEX Stainless Steel Stent and Delivery System features a balloonexpandable, stainless steel, welded wire stent that is delivered by a balloon catheter. The stent is provided premounted upon its associated balloon catheter. The Cordis PowerFlex and OPTA 5 Balloon Catheters are used for the delivery of the PERFLEX Stainless Steel Stents. The Cordis PERFLEX Stainless Steel Stent and Delivery System is advanced over a guidewire through a sheath lumen to an obstruction site in the biliary tree where the balloon is inflated to expand the stent. The balloon is then deflated and removed.

Also included with the Cordis PERFLEX Stainless Steel Stent and Delivery System is a stainless steel insertion tool that can be placed within the hemostatic valve of a commercially available introducer sheath to protect the stent / balloon catheter assembly during its insertion. Once the stent/balloon assembly passes through the valve, the insertion tool is removed.

The Cordis PERFLEX Stainless Steel Stent and Delivery System is provided sterile and is intended for single use only.

AI/ML Overview

This document, a 510(k) summary for the Cordis PERFLEX Stainless Steel Stent and Delivery System, focuses on demonstrating substantial equivalence to previously cleared devices rather than establishing novel safety and effectiveness criteria through a new clinical study with acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, specific study design, and performance metrics is not present in this submission.

Here's a breakdown of what can be extracted and what is not applicable:

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

This information is not provided in the document. The 510(k) summary for the Cordis PERFLEX Stainless Steel Stent and Delivery System states: "The safety and effectiveness of the Cordis PERFLEX Stainless Steel Stent and Delivery System have been demonstrated via data collected from nonclinical tests and analyses." It does not provide specific acceptance criteria or reported device performance metrics from a clinical study. The submission focuses on demonstrating substantial equivalence to predicate devices, implying that the established safety and effectiveness of those predicates are sufficient.

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 provided in the document. The submission references "nonclinical tests and analyses," which are typically bench tests or animal studies, not human clinical trials. Thus, there is no "test set" in the context of human data.

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 provided in the document. As there is no human "test set" or clinical study with ground truth established by experts, this is not applicable.

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

This information is not provided in the document. Not applicable as there is no human test set requiring adjudication.

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 provided in the document. MRMC studies are typically for AI/diagnostic imaging devices. This device is a medical implant (stent), and its approval process does not involve MRMC studies or AI assistance.

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

This information is not provided in the document. This is not an AI algorithm but a physical medical device; therefore, "standalone algorithm performance" is not applicable.

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

This information is not provided in the document beyond the mention of "nonclinical tests and analyses." For a physical device like a stent, ground truth in nonclinical tests would likely involve engineering specifications, materials testing results, and potentially animal model outcomes demonstrating mechanical integrity, patency, and biocompatibility, as compared to predicate devices.

8. The sample size for the training set

This information is not provided in the document. There is no mention of a "training set" in the context of machine learning or AI. For nonclinical tests, the "sample size" would refer to the number of devices tested, but this detail is not given.

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

This information is not provided in the document. Not applicable, as there is no training set in the context of AI. For nonclinical tests, the "ground truth" would be established by validated measurement techniques and adherence to engineering standards.

Summary of the Document's Approach to Demonstrating Safety and Effectiveness:

The document leverages the concept of substantial equivalence to predicate devices. This means that instead of conducting a new clinical study with specific acceptance criteria, and reporting performance against those criteria, the manufacturer is arguing that their new device is fundamentally similar in design, materials, components, method of delivery, and intended use to devices already cleared by the FDA. The "performance data" mentioned refers to nonclinical tests that confirm the new device's characteristics align with those of the predicate devices and meet established engineering and biocompatibility standards. The FDA's clearance (K980653) confirms that they found the device to be substantially equivalent.

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