(207 days)
The ANGIODYNAMICS ANGIOSTENT Biliary Stent System is indicated for palliative treatment of malignant strictures in the biliary tree.
Not Found
The provided document, a 510(k) premarket notification letter from the FDA for the AngioDynamics AngioStent Biliary Stent System, does not contain the information requested in your prompt regarding acceptance criteria, device performance results, or details of a study proving the device meets acceptance criteria.
This letter is a regulatory document confirming that the device is substantially equivalent to a legally marketed predicate device and can proceed to market, provided certain labeling limitations are met. It discusses regulatory classifications, general controls, and labeling requirements.
Therefore, I cannot populate the requested table or answer the specific questions about sample sizes, ground truth, expert qualifications, adjudication methods, MRMC studies, or standalone performance based on this document. The document's purpose is to grant market clearance, not to present a detailed study report.
§ 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.