(90 days)
The Resilience Fully Covered Esophageal Stent System is intended for maintaining esophageal luminal patency in patients with esophageal strictures caused by intrinsic and/or extrinsic malignant tumors and for occlusion of esophageal fistulae.
The MERIT ENDOTEK® Resilience™ Fully Covered Esophageal Stent System is a through-the-scope system comprised of two components: the radiopaque self-expanding nitinol stent and the delivery system. The stent is completely covered with a biocompatible silicone membrane. Stent expansion results from the physical properties of the metal and the proprietary geometry. The stent is designed with unique geometrical features at the distal and proximal ends to anchor the stent and resist migration. The proximal and distal ends of the stent are threaded with suture intended for use in repositioning and removal of the stent.
The stents come in nine (9) sizes, comprising all combinations of three lengths (5cm, 6cm, and 7cm) and three midbody diameters (14mm, 17mm, and 20mm). The midbody lengths are 1cm, 2cm, and 3cm with the flared ends comprising the remaining length. The ends of the stents are larger in diameter than the midbody.
There is one 10.5Fr delivery system used to deploy all 9 stents.
The provided FDA 510(k) clearance letter and summary for the Resilience Fully Covered Esophageal Stent System describes non-clinical testing to demonstrate substantial equivalence to a predicate device. However, it does not include information about clinical studies involving human readers or AI algorithms. The clearance is based on the device itself (the stent system), not an AI algorithm performing diagnosis or analysis.
Therefore, many of the requested points, especially those pertaining to AI performance, human reader studies, and ground truth establishment for AI, cannot be answered from the provided text.
Here's an analysis based on the information provided, focusing on the device's non-clinical testing:
Acceptance Criteria and Reported Device Performance (Non-Clinical)
The study described is a series of non-clinical, in-vitro tests on the mechanical and material properties of the Resilience Fully Covered Esophageal Stent System and its delivery system.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Stent Verification Testing | |
| Dimensions & Condition (post-deployment & removal) | Passed predetermined specifications |
| Suture purse-stringing ability | Passed predetermined specifications |
| Stent spring-back after purse-stringing | Passed predetermined specifications |
| Repositioning with forceps | Passed predetermined specifications |
| Suture withstands forceps | Passed predetermined specifications |
| Removal force | Passed predetermined specifications |
| Flare retention force | Passed predetermined specifications |
| Radial pressure forces (compression/expansion) | Passed predetermined specifications |
| Tensile strength | Passed predetermined specifications |
| Food flow | Passed predetermined specifications |
| Post-Fatigue Stent Testing | |
| Condition (post-fatigue) | Passed predetermined specifications |
| Removal force (post-fatigue) | Passed predetermined specifications |
| Flare retention force (post-fatigue) | Passed predetermined specifications |
| Radial pressure forces (compression/expansion, post-fatigue) | Passed predetermined specifications |
| Tensile strength (post-fatigue) | Passed predetermined specifications |
| Delivery System Testing | |
| Guidewire compatibility | Passed predetermined specifications |
| Catheter working length | Passed predetermined specifications |
| Catheter outer diameters | Passed predetermined specifications |
| Safety functionality | Passed predetermined specifications |
| Stent deployment force | Passed predetermined specifications |
| Stent repositioning after partial deployment | Passed predetermined specifications |
| Stent expansion after deployment | Passed predetermined specifications |
| Deployment accuracy | Passed predetermined specifications |
| Delivery system condition (post-deployment & removal) | Passed predetermined specifications |
| Tip-to-guidewire lumen bond strength | Passed predetermined specifications |
| Outer sheath-to-connector bond strength | Passed predetermined specifications |
| Egress plug-to-guidewire lumen bond strength | Passed predetermined specifications |
| Material/Environmental Testing | |
| Corrosion testing | Met all predetermined corrosion performance requirements |
| MRI compatibility | MR conditional in accordance with FDA's guidance |
| Biocompatibility testing | Met requirements of FDA Final Guidance ISO 10993-1 |
| Overall Design Validation | All design validation requirements were met |
Information Not Found in the Provided Text:
Since this is a clearance for a medical device (esophageal stent) and not an AI/software device, the following points related to AI studies are not applicable or not present in the provided document.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- This device clearance is based on non-clinical, in-vitro testing. It does not utilize "test sets" in the context of clinical data for AI analysis. The "test sets" here refer to batches of manufactured stents and delivery systems for mechanical and material property evaluation. Specific sample sizes for each non-clinical test are not detailed in this summary, but the summary states "all of the above testing passed the predetermined specifications" and "All design validation requirements were met."
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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):
- Not applicable as this is not an AI/software clearance based on expert-labeled clinical data. Ground truth for non-clinical device testing is typically based on engineering specifications and direct physical measurements/observations.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable.
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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 is not an AI-assisted device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical testing, the "ground truth" or "reference standard" would be the pre-defined engineering specifications and performance criteria derived from established medical device standards and the predicate device's performance benchmarks. For biocompatibility, the ground truth is compliance with ISO 10993-1.
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The sample size for the training set:
- Not applicable, as this is not an AI/software device. There is no "training set" in the context of machine learning.
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How the ground truth for the training set was established:
- Not applicable.
§ 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.”