(137 days)
The Ultraflex Esophageal NG Stent is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors only. The Ultraflex Esophageal NG Covered Stent System is also indicated for occlusion of concurrent esophageal fistula.
The WallFlex Esophageal Partially Covered and Fully Covered Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic malignant tumors, and occlusion of concurrent esophageal fistulas.
The Ultraflex Esophageal NG Stent System allows placement of a self-expanding metallic stent within the esophagus. The systems consist of a flexible delivery system preloaded with an expandable with or without a cover. The WallFlex Esophageal Stent System consists of a self-expanding esophageal metal stent and a delivery system.
The provided text is an FDA 510(k) clearance letter and a 510(k) summary for Boston Scientific's Ultraflex Esophageal NG Stent System and WallFlex Esophageal Stent System. This document explicitly states that the proposed devices are identical to their legally marketed predicate devices in design, material, chemical composition, fundamental technology, principle of operation, sterilization, packaging, shelf-life, and manufacturing process.
Therefore, the submission does not describe a study involving acceptance criteria and device performance based on a test set, expert ground truth, or AI assistance. The clearance is based on the substantial equivalence of the new devices to existing, already cleared devices.
Here's why the requested information cannot be extracted from this document:
- No new performance data is presented. The core argument for clearance is "identity" to predicates, not "improved performance" or meeting specific performance thresholds through new testing against a defined ground truth.
- The document states, "The testing performed on the proposed Ultraflex Esophageal Stent System and WallFlex Esophageal Stent System demonstrates the devices are substantially equivalent." This testing would likely be engineering or bench performance tests (e.g., stent radial force, deployment accuracy, material compatibility) to demonstrate the identity and safety of the new devices, not clinical performance against a diagnostic task or a clinical outcome. These tests are not detailed in the provided summary.
- The context is a 510(k) premarket notification for a Class II device. For such devices, especially those claiming identity to predicates with established performance, a comparative effectiveness study involving human readers with and without AI assistance is generally not required or performed.
- AI/Machine Learning is not mentioned. The document describes physical medical devices (stents), not AI-powered diagnostic or therapeutic tools.
In summary, the provided text does not contain the information requested regarding acceptance criteria, study design (test set, ground truth, experts, adjudication, MRMC, standalone), or training set details because the basis for clearance is substantial equivalence (identity) to existing devices, not a new performance claim for an AI/ML-driven device or a device requiring new clinical performance validation in the way described in your prompt.
§ 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.”