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The RAS Racks are used in the RAS Cycles of AMSCO 7052HP and 7053HP Single-Chamber Washer/Disinfectors for the effective cleaning, rinsing, drying and intermediate level disinfection of reusable da Vinci EndoWrist® X/Xi, S/Si, and Single-Site instruments and staplers.

The RAS Racks are designed to enable the mechanical cleaning, rinsing, and disinfection of up to twelve (12) robotic-assisted surgery instruments in a compatible washer-disinfector. Twelve soiled da Vinci Endowrist® X/Xi, S/Si, or Single-Site instruments and staplers, without prior manual cleaning, are loaded into the appropriate RAS Rack according to the provided instructions for use. The rack is placed in the AMSCO 7052HP or 7053HP Single-Chamber Washer/Disinfector, and the RAS Cycle is selected.

The RAS Cycle performs automated cleaning through a validated series of spraywashing, lumen flushing steps that use Prolystica Ultra Concentrate HP Enzymatic Cleaner alternately with Prolystica Ultra Concentrate HP Neutral Detergent in temperature-controlled solutions. When the series of automated prewash and washing stages are complete, a one-minute rinse occurs. Next the RAS Cycle completes a thermal rinse to achieve intermediate level disinfection of the load before drying it. Upon RAS Cycle completion, the devices are ready to be prepared and packed for steam sterilization.

I am sorry, but the provided text does not contain the acceptance criteria or a study proving that the device meets acceptance criteria. The document is an FDA 510(k) premarket notification for a medical device (STERIS RAS 12 Rack and RAS Cycle), which states that the proposed device is substantially equivalent to a legally marketed predicate device (K190081).

The document details the device's intended use, technological characteristics, and compares it to the predicate device. However, it explicitly states in "Summary of Non-Clinical Performance Testing" that "The purpose of this Special 510(k) is to update labeling based on a labeling revision being enacted by Intuitive Surgical to allow for automated cleaning and intermediate level disinfection... The RAS Racks and associated RAS Cycles were not altered in anyway." This implies that the performance testing was likely conducted for the predicate device (K190081) and is referenced, but the details of such a study are not present in this document.

Therefore, I cannot extract the requested information such as a table of acceptance criteria and reported performance, sample sizes, expert qualifications, adjudication methods, MRMC study details, standalone performance, type of ground truth, or training set details.

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