FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

Stent Description: This flexible, self-expanding stent is constructed of nitinol wire with a silicone cover. The total length of the stent is indicated by radiopaque markers on the inner catheter, indicating the actual length of the stent at nominal stent diameter. There is a lasso at the proximal end of the stent whose purpose is to reposition the stent as needed.

Introducer System Description: The stent is mounted on an inner catheter, which accepts a 0.035 inch guidewire and is constrained by an outer catheter. A pistol-grip delivery handle allows stent deployment or rccapture.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not contain a table of acceptance criteria or quantitative device performance metrics that would typically be found in a study. The document is a 510(k) summary and FDA clearance letter, which focuses on demonstrating substantial equivalence to already marketed devices.

Instead of performance metrics against acceptance criteria, the document states:

"Non clinical testing was carried out to determine the equivalence of the Evolution™ Esophageal Stent System to the predicate devices and to verify the safety and effectiveness of the device."
"The following is a summary of the testing carried out: deployment force testing, expansion force testing, compression force testing, dimensional testing, corrosion testing and tensile strength testing."

2. Sample size used for the test set and the data provenance

The document describes non-clinical testing on the device itself (stent and introducer system components) rather than testing on patients or human subjects. Therefore, the concept of a "test set" in the context of patient data (e.g., medical images for an AI device) or data provenance (country of origin, retrospective/prospective) is not applicable here. The testing involved various engineering and materials science tests on the device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This section is not applicable as the testing described is non-clinical (device characteristic testing) and does not involve expert interpretation or establishment of ground truth in a clinical sense.

4. Adjudication method for the test set

This section is not applicable as the testing involved non-clinical, objective measurements of device characteristics, not clinical assessments 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

There is no mention of an MRMC comparative effectiveness study, human readers, or AI assistance. This document describes the clearance of a physical medical device (an esophageal stent), not an AI/software device.

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

This section is not applicable as the device is a physical medical implant (an esophageal stent), not an algorithm or AI system.

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

For the non-clinical tests conducted, the "ground truth" would be the physical properties and performance characteristics of the device measured against predetermined specifications or industry standards for similar devices. This is not clinical ground truth in the sense of expert consensus or pathology.

8. The sample size for the training set

This section is not applicable. The device is a physical stent and does not involve a training set for an algorithm.

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

This section is not applicable. The device is a physical stent and does not involve a training set for an algorithm.

Summary of what the document does tell us:

The document describes the Cook Ireland Ltd. Evolution™ Esophageal Stent System. It is a flexible, self-expanding nitinol stent with a silicone cover, designed to maintain patency of malignant esophageal strictures and/or seal tracheoesophageal fistulas.

The basis for its 510(k) clearance (K080359) by the FDA in 2008 was its substantial equivalence to several legally marketed predicate devices:

Esophageal Z Stent with Dua Anti-Reflux Valve (K011591)
Wallstent II Esophageal Prosthesis (K940395)
Ultraflex™ Esophageal NG Stent System (K032930)

To demonstrate this equivalence and verify safety and effectiveness, Cook Ireland Ltd. performed non-clinical testing, including:

Deployment force testing
Expansion force testing
Compression force testing
Dimensional testing
Corrosion testing
Tensile strength testing

The specific numerical results of these tests and the acceptance criteria they had to meet are not detailed in this summary document, but the FDA's clearance indicates that these tests were sufficient to demonstrate substantial equivalence.

Summary

Regulation Number and Section

§ 878.3610 Esophageal prosthesis.

(a)
Identification. An esophageal prosthesis is a rigid, flexible, or expandable tubular device made of a plastic, metal, or polymeric material that is intended to be implanted to restore the structure and/or function of the esophagus. The metal esophageal prosthesis may be uncovered or covered with a polymeric material. This device may also include a device delivery system.(b)
Classification. Class II. The special control for this device is FDA's “Guidance for the Content of Premarket Notification Submissions for Esophageal and Tracheal Prostheses.”