(74 days)
The WallFlex™ Biliary RX Stent System Uncovered, WallFlex™ Biliary RX Stent System Partially Covered, and WallFlex™ Biliary RX Stent System Fully Covered are indicated for use in the palliative treatment of biliary strictures produced by malignant neoplasms.
The WallFlex™ Biliary RX Stent System Uncovered, WallFlex™ Biliary RX Stent System Partially Covered, and WallFlex 114 Biliary RX Stent System Fully Covered consist of a flexible delivery system preloaded with a self-expanding biliary metal stent.
The stent is offered uncovered or covered. The covered stents are offered as fully covered, or partially covered with a Permalume™ stent covering. The stent wires have a radiopaque core to improve radiopacity.
The stent is preloaded onto the delivery system. which has radiopaque marker bands used to aid in imaging during deployment of the stent. The delivery system accommodates a 0.035 in (0.89 mm) guidewire.
The provided text is a 510(k) summary for the WallFlex™ Biliary RX Stent System, which is a medical device. This document does not describe the acceptance criteria and a study proving a device meets those criteria in the context of an Artificial Intelligence (AI) or software-as-a-medical-device (SaMD) study.
Instead, this document focuses on the substantial equivalence of the WallFlex™ Biliary RX Stent System to its predicate devices for a specific labeling claim regarding MR Conditional safety and compatibility. The performance data mentioned is for in-vitro testing on the biliary metal stent, which is typical for hardware medical devices, not AI/SaMD.
Therefore, I cannot extract the requested information (acceptance criteria, device performance, sample sizes for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or ground truth types) because the provided text does not describe an AI/SaMD study. It's a regulatory submission for a physical medical device.
§ 876.5010 Biliary catheter and accessories.
(a)
Identification. A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.(b)
Classification. Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.