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The System 83 Revolve® Endoscope Washer/Disinfector is designed for the high-level disinfection of one or two flexible submersible endoscopes that are used in the gastrointestinal and pulmonary tracts. Flexible endoscopes that undergo bedside cleaning, are manually cleaned, and then exposed to the wash/disinfect cycle of the System 83 Revolve® may be high-level disinfected when the validated disinfection cycle of the System 83 Revolve® corresponds with the labeled contact conditions of the high-level disinfectant.

The System 83 Revolve® Endoscope Washer/Disinfector is an automated, computer controlled, electro-mechanical system intended to wash and high-level disinfect one or two submersible flexible endoscopes utilizing a detergent and FDA cleared high-level disinfectant validated by Wassenburg Medical.

The System 83 Revolve® utilizes a processing chamber and the perform washing, disinfection, rinsing, and alcohol flush of an endoscope to render a high-level disinfected endoscope. The System 83 Revolve® is capable of automated detergent dispensing and transfer of disinfectant solution between the reservoir and processing chamber. Following disinfection, the endoscopes and channels are automatically rinsed with potable water that is filtered through a water filtration system that contains a 0.1 micron bacteria filter and the rhannels are then flushed with air. A semi-automated air/alcohol flush must be completed at the end of the cycle. At completion, the operator prints out the endoscope reprocessing information with a printer.

Built-in sensors detect fluid levels, fluid flow, and the operating states of the components within System 83 Revolve". The system contains a Touchscreen (Graphical User Interface), a Barcode Scanner, an LED Indicator Strip that displays the process status, and a reprocessing chamber lid operation that is hands free.

The provided text is a 510(k) summary for a medical device (System 83 Revolve® Endoscope Washer/Disinfector), which is a premarket notification for a Class II medical device. This type of document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than detailed performance study results of an AI algorithm or a standalone diagnostic device.

Therefore, the information typically requested for AI-driven diagnostic devices (such as a table of acceptance criteria vs. reported device performance for an AI, sample sizes for training/test sets for AI, expert qualifications, ground truth establishment methods for AI, or MRMC studies for AI assistance) is not present in this document. This document is about an endoscope washer/disinfector, an electromechanical system, not an AI or diagnostic imaging device.

Based on the provided document, here's what can be extracted regarding acceptance criteria and performance:

The document describes the acceptance criteria and performance for the endoscope washer/disinfector itself, ensuring it functions correctly and is safe, rather than evaluating an AI's diagnostic performance.

1. A table of acceptance criteria and the reported device performance

The document provides two tables:

• Table 2. New Testing: This table outlines testing performed for the subject device to ensure it meets safety and software standards. These are not performance metrics like sensitivity/specificity but rather compliance with engineering and software standards.
• Table 3. Testing performed for Predicate Device: This table lists performance testing conducted on the predicate device, which the subject device aims to be substantially equivalent to. The results from the predicate device's testing are used to support the subject device's equivalence.

Table 2. New Testing (for Subject Device: System 83 Revolve® Endoscope Washer/Disinfector)

Table 3. Testing performed for Predicate Device (Used to support SE of Subject Device)

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