(30 days)
Ultraflex™ Esophageal NG Stent System (covered) is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors only, and occlusion of concurrent esophageal fistula.
The proposed Ultraflex Esophageal NG Stent System allows for the placement of a selfexpanding metallic stent within the esophagus. The systems consist of a flexible delivery catheter preloaded with an expandable stent. The stent is offered covered with either a proximal release or distal release delivery system. The stent may be placed fluoroscopically using radiopaque markers as a guide or endoscopically using the visual marker on the delivery catheter. The proposed device incorporates a material formulation change for the stent covering and covering adhesive material.
The provided text does not contain information about acceptance criteria and a study proving a device meets them in the context of an AI/ML-based medical device. Instead, the document describes a 510(k) summary for a medical device called the "Ultraflex™ Esophageal NG Stent System."
This submission is a Special 510(k) Premarket Notification for a device that is substantially equivalent to a previously cleared device. The key difference in the proposed device is a material formulation change for the stent covering and covering adhesive material.
Therefore, the "performance data" section focuses on in-vitro testing to demonstrate that this material change does not negatively impact the device's performance. There is no mention of an AI/ML component, diagnostic performance metrics (like sensitivity, specificity, accuracy), or any studies involving human readers or ground truth establishment relevant to AI.
Here's why the requested information cannot be extracted:
- No AI/ML Component: The device is a physical medical implant (stent) and does not involve artificial intelligence or machine learning for diagnostic or assistive purposes.
- Performance Data Type: The "Performance Data" mentioned (dimensional, tensile strength, integrity, exposure resistance, chemical analysis, and biocompatibility) are typical for material changes in medical devices, not for evaluating AI algorithms.
- Comparison to Predicate: The entire submission is built on demonstrating substantial equivalence to a legally marketed predicate device, primarily through in-vitro testing for the material change.
Therefore, I cannot provide the requested table and details because the provided input document describes a traditional medical device submission (a stent with a material change), not an AI/ML 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.”