(362 days)
For use in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors.
The Esophageal TTS Stent consists of an implantable metallic stent and a flexible introducer system. The stent is a flexible, expandable tubular device made of Nitinol wire and are either fully silicone covered or partially silicone covered (the body is covered but both heads remains uncovered). This device also includes a disposable introducer. Upon deployment, the stent imparts an outward radial force on the luminal surface esophagus to establish patency.
The provided text describes the regulatory clearance for the Esophageal TTS Stent but does not contain information about a study proving the device meets acceptance criteria in the context of AI/ML or diagnostic performance metrics.
The document is a 510(k) summary for a medical device (an esophageal stent), which focuses on demonstrating substantial equivalence to a predicate device based on engineering and mechanical performance tests, rather than clinical efficacy studies with human subjects that would typically involve acceptance criteria for diagnostic accuracy, sensitivity, or specificity.
Therefore, most of the requested information cannot be extracted from this document, as it pertains to a different type of device evaluation (e.g., AI/ML-driven diagnostic tools).
Information Based on the Provided Text:
Here's what can be inferred or directly stated from the document, acknowledging that most of the requested fields are not applicable to this type of device clearance:
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A table of acceptance criteria and the reported device performance
Acceptance Criteria (Type of Test) Reported Device Performance (Summary) Expansion Force Testing Demonstrated safety and effectiveness. Compression Force Testing Demonstrated safety and effectiveness. Dimensional Testing Demonstrated safety and effectiveness. Deployment Testing Demonstrated safety and effectiveness. Deployment Force Testing Demonstrated safety and effectiveness. Tensile Strength Testing Demonstrated safety and effectiveness. Packaging Adhesive Strength Testing Demonstrated safety and effectiveness. MR Compatibility Demonstrated safety and effectiveness. Overall Conclusion "The performance testing showed that the Esophageal TTS Stent with a larger body diameter of 20mm is as safe, as effective, and performs as well as or better than the predicate device." -
Sample sized 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 performance data section refers to engineering tests on the device, not a human reader or image-based test set.
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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)
- This information is not provided and is not applicable to the type of device (a medical implant) and the type of testing described (engineering performance tests).
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not provided and is not applicable to the type of testing described.
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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
- No, an MRMC study was not done. This document describes the clearance of an esophageal stent, not an AI/ML diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- This is not applicable as the device is a physical medical implant, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the engineering performance tests would be the established engineering specifications and physical properties benchmarks. This is not explicitly detailed in the document beyond stating that "Performance Data" was collected per FDA "Guidance for Industry - Guidance for the Content of Premarket Notifications for Esophageal and Tracheal Prostheses."
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The sample size for the training set
- This is not applicable as the document describes the clearance of a physical medical device, not an AI/ML algorithm that requires a training set.
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How the ground truth for the training set was established
- This is not applicable as the document describes the clearance of a physical medical 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.”