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The Flexible Video-Choledo-Cysto-Ureteroscope System is indicated for endoscopic examination in the urinary tract and can be used percutaneously to examine the interior of the kidney, and using additional accessories, to perform various diagnostic and therapeutic procedures. The Flexible Video-Choledo-Cysto-Ureteroscope System is also indicated for the examination of bile ducts surgically, and using additional accessories, to perform various diagnostic and therapeutic procedures during cholecystectomy.

Imaging Processor System (Including Light Source) is composed of lighting system, image processing board. The lighting system provides the light source for the endoscope probe at the back end. The image processing board receives electronic signals from the front-end camera module and processes them, and finally transmits them to the display through the video interface. Flexible Video-Choledo-Cysto-Ureteroscope is a kind of medical electronic optical instrument, also known as optical camera, which can enter into the human bladder, ureter, 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. The product is equipped with tiny size digital imaging parts -- photoelectric sensors "CMOS", on which the objects in human cavity will be transferred though lens optical system, and converts light signals into electrical signals. The electrical signal will be transferred to Imaging Processor System (Including Light Source) and display images on it's monitor output for doctor observation and diagnosis.

This document is a 510(k) premarket notification for a new medical device, the Flexible Video-Choledo-Cysto-Ureteroscope System (PL-2100). This type of submission relies on demonstrating "substantial equivalence" to a predicate device, meaning it's as safe and effective as a device already legally marketed. Therefore, the "study" referred to is primarily a non-clinical performance evaluation comparing the proposed device to a predicate device, rather than a clinical trial or AI-specific validation study typically associated with AI/ML devices.

Here's an analysis of the provided information concerning acceptance criteria and the "study":

1. Table of Acceptance Criteria and Reported Device Performance:

The document provides a comparative table between the proposed device (PL-2100) and its primary predicate device (Flexible Video-Choledo-Cysto-Ureteroscope System, K211686, Model: PL-1000). The "acceptance criteria" are implied by the predicate device's characteristics, and the "reported device performance" are the proposed device's characteristics. The goal is to show they are "Same" or "Similar" in ways that don't raise new questions of safety or effectiveness.

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