(35 days)
The WallFlex Esophageal Fully Covered Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistula.
The proposed WallFlex Esophageal Fully Covered Stent System consists of a selfexpanding metal stent and a delivery system. The proposed stent is manufactured from a metallic radiopaque material that is formed into a cylindrical mesh. It is fully covered with a silicone polymer. A suture is threaded through the proximal end of the stent and is intended to aid in removal during the initial stent placement procedure, to be used in the event of incorrect placement. The delivery system is a coaxial tube design. The exterior tube is used to constrain the stent before deployment and reconstrain the stent, if desired, after partial deployment. The exterior tube has a clear section so that the contrained stent is visible. The interior tube has a single central lumen to accommodate a 0.038" guidewire.
The provided document describes the WallFlex Esophageal Fully Covered Stent System and its substantial equivalence to predicate devices. It does not contain information about specific acceptance criteria, a study proving the device meets those criteria, or details regarding a study involving AI, human readers, or ground truth establishment.
The document states:
- "In-vitro testing has been performed and all components, subassemblies, and/or full devices met the required specifications for the completed tests." This indicates that performance data exists, but the specific acceptance criteria and the detailed results of these tests are not provided in this summary.
Therefore, I cannot populate the table or answer the specific questions related to acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, as these details are not present in the provided text.
The document primarily focuses on establishing substantial equivalence based on design, materials, and manufacturing processes, rather than presenting a detailed clinical performance study with specific metrics.
§ 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.”