Search Results

The Flexible Video-Choledochoscope is indicated for use in diagnostic and therapeutic applications during endoscopic procedures in the pancreatico-biliary system including the hepatic ducts.

Flexible Video-Choledochoscope is a kind of medical instrument, also known as optical camera, which can enter into the human biliary and pancreatic duct for observation and diagnosis. The operator delivers the optical camera system to the site of diagnosis and treatment by means of a mechanical part with a flexible insertion tube and a system of bends. This device must be used with a duodenoscope. The product is equipped with tiny size digital imaging parts -- photoelective sensors "CMOS", on which the objects in human cavity will be transferred though lens optical system, and converts light signals. The electrical signal will be transferred to Imaging Processor System (Including Light Source) and display images on its monitor output for doctor observation and diagnosis.

I am sorry, but the provided text does not contain information about the acceptance criteria and the study that proves the device meets those criteria. The document is an FDA 510(k) clearance letter for a Flexible Video-Choledochoscope, which asserts substantial equivalence to a predicate device based on technical and performance characteristics.

Specifically, the document mentions:

• No Clinical Study is included in this submission. (Section 5.9 Clinical Test Data)
• Non-clinical Performance Data: "The following performance tests were conducted to substantial equivalence: mechanical performance: duodenosoone compatibility testing and flexible surgical instrument compatibility testing and comparison performance testing." (Section 5.8 Non-clinical Performance Data)

Therefore, I cannot provide the detailed information requested in your prompt regarding acceptance criteria, device performance, sample sizes, ground truth establishment, or any comparative effectiveness studies.

Ask a specific question about this device