(206 days)
This device is used to maintain patency of malignant esophageal strictures and / or to seal tracheoesophageal fistulas.
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 are lasso loops at both the proximal and distal ends 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 wire guide and is constrained by an outer catheter. A pistol-grip delivery handle allows stent deployment or recapture.
The provided text is a 510(k) summary and an FDA clearance letter for a medical device called the Evolution™ Esophageal Stent System - Fully Covered. This type of document focuses on establishing substantial equivalence to a predicate device, rather than presenting a performance study with detailed acceptance criteria and a comprehensive report of device performance against those criteria in a clinical or simulated environment.
Therefore, the prompt's request for a table of acceptance criteria and reported device performance from a study proving the device meets the acceptance criteria cannot be fully satisfied with the provided information in the way it would for a performance study.
However, based on the text, we can infer some "acceptance criteria" through the regulatory requirements and testing mentioned:
Inferred Acceptance Criteria and Reported Device Performance (Based on 510(k) Summary):
| Acceptance Criteria Category/Type | Reported Device Performance/Evidence from 510(k) Summary |
|---|---|
| Substantial Equivalence: | The proposed device is substantially equivalent to the currently marketed device, the Evolution™ Esophageal Stent System, as cleared by K080359. |
| Biocompatibility: | Addressed through the Design Control Process, as per FDA guidance. (Specific results are not provided). |
| Sterility: | Addressed through the Design Control Process, as per FDA guidance. (Specific results are not provided). |
| Labeling Requirements: | Addressed through the Design Control Process, as per FDA guidance. (Specific details are not provided). |
| Deployment Testing: | Applied to the proposed device. (Specific results/metrics are not provided, but implies successful deployment). |
| Dimensional Testing: | Applied to the proposed device. (Specific results/metrics are not provided, but implies meeting design specifications). |
| Expansion Force Testing: | Applied to the proposed device. (Specific results/metrics are not provided, but implies meeting required expansion force). |
| Compression Force Testing: | Applied to the proposed device. (Specific results/metrics are not provided, but implies meeting required compression resistance). |
| Corrosion Testing: | Applied to the proposed device. (Specific results/metrics are not provided, but implies resistance to corrosion). |
| Tensile Strength Testing: | Applied to the proposed device. (Specific results/metrics are not provided, but implies structural integrity under tension). |
| Indications for Use: | Device is used to maintain patency of malignant esophageal strictures and / or to seal tracheoesophageal fistulas, which matches the predicate device. |
Study Information (Based on the Provided Text):
The provided text describes a 510(k) premarket notification, which establishes substantial equivalence to a previously cleared predicate device (K080359). It does not present a clinical performance study with human subjects, a test set, expert ground truth, or MRMC analysis in the way typically associated with AI/CADe devices.
Instead, the performance data cited refers to a series of benchtop tests and adherence to regulatory guidance for medical devices, particularly esophageal and tracheal prostheses.
Here's an analysis based on the information provided:
-
Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable in the context of a clinical test set with human data. The 'test set' here refers to physical stents and possibly components used in benchtop testing. The document does not specify the number of stents/components tested for each physical performance criterion (e.g., how many stents were subjected to expansion force testing).
- Data Provenance: The testing was likely conducted in a controlled laboratory environment by Cook Ireland Ltd., as part of their Design Control Process, in accordance with FDA guidance from 1998. The specific country of origin of the physical materials or test environment is not explicitly stated beyond "Cook Ireland Ltd."
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. For a 510(k) for a stent, "ground truth" is typically established by engineering specifications, material science principles, and adherence to recognized performance standards for medical devices, rather than expert clinical consensus on a "test set" of patient data. The "experts" would be the engineers and scientists conducting and reviewing the physical performance tests.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in image interpretation or clinical diagnosis scenarios, not for the physical performance testing of a medical device like a stent.
-
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:
- No. This is not an AI/CADe device. No MRMC study was conducted or is relevant for this type of medical device submission.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is not an algorithm-based device.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the physical tests (biocompatibility, sterility, deployment, dimensional, expansion force, compression force, corrosion, tensile strength), the "ground truth" or reference criteria would be engineering specifications, material standards, and regulatory performance requirements (e.g., ISO standards, ASTM standards, or internal validated Cook specifications) outlined in the FDA guidance document from 1998 for esophageal and tracheal prostheses.
-
The sample size for the training set:
- Not Applicable. This is not a machine learning or AI device that requires a training set.
-
How the ground truth for the training set was established:
- Not Applicable. This is not a machine learning or AI device.
§ 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.”