Search Results

This instrument has been designed to be used with an Olympus endoscope I mis instrument mas count in the biliary and pancreatic ducts, although it is not designed for the deep insertion into the pancreatic duct.

The subject device is a cannula which has a bending function (angle wire), to be used in accordance with Intended Use of the Device. This bending function enables the subject device to be manipulated in 2 directions and leads to easier insertion into the biliary and pancreatic ducts.

This document is a 510(k) premarket notification for a medical device called the "DISPOSABLE BENDING CANNULA PR-233Q." It focuses on demonstrating substantial equivalence to predicate devices, and therefore, it does not contain acceptance criteria, a study proving device meets acceptance criteria, or information regarding AI performance metrics.

The document describes the device, its intended use, and provides a comparison to predicate devices, focusing on the lack of significant changes that would affect safety or effectiveness.

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, ground truth, expert qualifications, or AI performance. The document's purpose is to obtain FDA clearance based on substantial equivalence, not to present a detailed performance study with specific metrics.

Ask a specific question about this device