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The ACMI Electronic Video CystoNephroscope (ECN) System is a flexible endoscopic surgical video system consisting of an endoscope, CMOS video sensor and light source mounted in the endoscope, and a Controller unit. This system is intended for use to examine body cavities, hollow organs and canals in the body, in the urinary tract, and can be used percutaneously to examine the interior of the kidney; and, using additional accessories, can be used to perform various diagnostic and therapeutic procedures

The ECN Video Cystonephroscope is a flexible endoscope that incorporates video sensor technology to capture the endoscopic image, replacing the fiber optic image bundle typically used in most endoscopes. The ECN Video Cystonephroscope can be introduced either through the urethra into the bladder or through a percutaneous tract into the abdominal cavity or kidney

This 510(k) premarket notification for the ACMI ECN Video Cystonephroscope does not contain the detailed information required to answer the questions about acceptance criteria and a study that proves the device meets those criteria.

The document is a submission to the FDA for substantial equivalence to legally marketed predicate devices, not a report on a clinical or performance study with defined acceptance criteria. It primarily focuses on comparing the new device's technological characteristics and intended use to existing devices.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, ground truth establishment, expert qualifications, or MRMC studies.

Here's why the information is missing:

• 510(k) Premarket Notification: This type of submission aims to demonstrate that a new device is as safe and effective as a legally marketed predicate device, primarily through comparison of technological characteristics and intended use. It often does not require new clinical trials or performance studies with specific statistical endpoints like those requested in your prompt, unless there are significant differences from the predicate that raise new questions of safety or effectiveness.
• Focus on Substantial Equivalence: The document explicitly states its purpose is to show "Technological Characteristics and Substantial Equivalence." It lists predicate devices and highlights how the ECN Flexible Video Cystonephroscope utilizes existing flexible endoscope technology, video sensor technology (CMOS), and video processing technology found in those predicates.
• Lack of Performance Data: The provided text does not include any performance metrics, success criteria, or results from a study designed to quantify the device's accuracy, sensitivity, specificity, or inter-reader agreement.

In summary, the provided document is a regulatory filing for market clearance based on substantial equivalence, not a detailed performance study with acceptance criteria.

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