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The AQUAbase nX is intended for use with hemodialysis systems to remove organic and inorganic substances and microbial contaminants from the water used for treating hemodialysis patients. The AQUAbase nX is to be used at dialysis clinics or hospitals.

The AQUAbase nX is a reverse osmosis unit intended to be a component in a complete water purification system, and is not a complete water treatment system. This reverse osmosis unit must be preceded by pre-treatment devices. Whether a particular device is included in an individual water treatment system will be dictated by local conditions. The reverse osmosis unit may need to be followed by post-treatment devices as well.

The AQUAbase nX is designed to meet current AAMI/ISO and Federal (U.S.) standards.

The AQUAbase nX is a single stage reverse osmosis system. A graphical touchscreen allows access and monitoring of all operating parameters at any time. Customized parameters make a high water vield possible, even under poor raw water conditions. Raw water consumption is based solely on the end user's permeate needs. The touchscreen makes it possible for the user to monitor all production parameters as well as design every system function, including disinfection mode, individually and reproducibly.

The AQUAbase nX works on the reverse osmosis principle. Reverse osmosis describes the process of pressure-operated cross-filtration. Water flows at high pressure tangentially over a semipermeable membrane. As is the case with normal filtration, the system is cleaned by allowing one component (water) of the mixture to be separated to pass through the membrane with almost no hindrance, while other components (dissolved and undissolved water contents) are held back to a greater or lesser extent and leave the filtration unit in the concentrate flow. This is a purely physical separation process in the molecular range which does not change the components being separated either chemically, biologically or thermally.

The provided document is a 510(k) summary for the AQUAbase nX, a water purification system for hemodialysis. It details the device's characteristics, intended use, and comparison to a predicate device, along with performance data.

However, the information provided does not contain the details required to describe the acceptance criteria and study that proves the device meets the acceptance criteria in the context of an AI-powered medical device.

The document discusses "performance data" which includes:

• Biocompatibility testing (ISO 10993-1)
• Electrical safety and electromagnetic compatibility (EMC) testing (IEC 60601-1, IEC 60601-1-2)
• Software verification and validation testing (FDA Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" as well as the draft FDA guidance recently issued)
• Additional performance bench testing (ISO 23500-3 for performance, chemical and heat disinfection testing, bacterial count and endotoxins)

These are standard engineering and medical device performance tests. There is no mention of an AI algorithm, a test set for AI, ground truth establishment by experts, MRMC studies, or standalone AI performance.

Therefore, I cannot fulfill the request as the provided text does not contain any information about an AI component or a study proving an AI device meets acceptance criteria. The device described is a physical water purification system, not an AI-powered diagnostic or assistive tool.

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