(278 days)
The EGIS Biliary Double Bare Stent is indicated for the palliation of malignant strictures in the biliary tree.
EGIS Biliary Double Bare Stent has straight and round cylinder form made of nitinol wire. The double bare type is composed of two structures, an inner stent and an outer stent, and has a double-layer form. Each stent has the same structure as the single bare type of the product. A double layer is formed by overlapping a separately manufactured inner stent and an outer stent, and both ends are physically fixed using medical sutures. No additional bonding material in this process. This manufacturing method also allows the product to have more conformability and a smaller cell size.
The provided FDA 510(k) clearance letter for the EGIS Biliary Double Bare Stent does not contain any information about a study involving acceptance criteria for device performance with respect to AI or human reader assistance.
The document primarily focuses on demonstrating the substantial equivalence of the EGIS Biliary Double Bare Stent to a predicate device (EGIS Biliary Single Bare Stent) through non-clinical bench testing and biocompatibility evaluation. The letter explicitly states: "Clinical testing was not required for this submission." This means no human-in-the-loop or standalone AI performance studies were conducted or reported in this clearance.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria based on the provided input. The information requested regarding AI performance, human reader studies, ground truth establishment, expert adjudication, and training/test set details is entirely absent from this 510(k) clearance letter, as it's not relevant to the type of device (a biliary stent) or the regulatory pathway chosen (510(k) based on substantial equivalence through non-clinical data).
If you have a document pertaining to an AI device or a study involving human reader performance, please provide that document, and I would be happy to analyze it according to your requested criteria.
§ 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.