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The Single Use Cleaning Adapter is intended to be used only to pre-clean an endoscope's air/water channel post-procedure, and not to be used during a patient procedure.

This device is intended as part of the pre-cleaning process, to help clear the air/water channel of Olympus GI endoscopes post procedure.

The Defendo Single Use Cleaning Adapter for Olympus Endoscopes is a single use, sterile disposable valve that fits onto the air/water cylinder of Olympus endoscopes (that do not contain a balloon channel). It allows air and water to be flushed through the endoscope's air/water channels after an endoscopic procedure is completed to remove debris. The adapter is not intended to be used with patients and a warning tag comes with the device providing this information. The materials of the valve are nonpatient contacting. The adapter is used post-procedure to pre-clean the endoscope before it goes through high-level disinfection and/or sterilization. The adapter is attached to the air/water channel of an endoscope. When the adapter is attached to the endoscope, air can flow down the channel of the endoscope. If water is desired to flow down the channel, the device is depressed. When released, air will once again flow down the endoscope channel. The Defendo Single Use Cleaning Adapter for Olympus Endoscopes assembly consists of a cap, a spring, a spring cup, an overmolded boot, the cleaning valve stem, the valve stem backflow umbrella valve, and valve stem sealing gaskets and a warning label.

The provided document is a 510(k) premarket notification from STERIS Corporation to the FDA for a medical device called "Defendo Single Use Cleaning Adapter for Olympus Endoscopes." However, this document does not contain information about an AI/ML-driven device or studies related to AI/ML performance.

The listed tests (Button cycling/leak test, Fluid Flow Path, Air Flow Rate, CO2 Flow Rate, Water Flow Rate, Backpressure Hold Test, Valve to Port Attachment Force, Valve to Port Removal Force, Valve Depression Force, Cap breakage strength, Sterile Barrier: Visual Inspection, Sterile Barrier: Dye Penetration) are all related to the mechanical and physical performance of a cleaning adapter, not to the performance of an AI algorithm.

Therefore, I cannot extract the information requested about acceptance criteria and studies proving the device meets criteria in the context of an AI/ML device. The document describes a physical medical device (a cleaning adapter) and its non-clinical performance testing.

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