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Virginia Water Systems' Water Purification for Hemodialysis is intended to remove organic, inorganic, and microbial contaminants from water used to make dialysate and reprocess dialyzers as well as rinsing and disinfection of the dialysis equipment. When used as a medical device, Federal law restricts this device to sale by or on the order of a physician.

Virginia Water Systems' Water Purification for Hemodialysis is complete water treatment system used in the production of ultrapure water used in hemodialysis facilities. The components consist of the following: Blend Valve, Inlet Booster Pump, Multimedia Filter, Softener, Carbon Tanks, Reverse Osmosis Unit, Water Storage Tank, Repressure Pumps, Deionizer, Ultraviolet Light, Submicron Filter, Hollow Fiber Filter.

The provided document is a 510(k) summary for the Virginia Water Systems' Water Purification for Hemodialysis. It outlines the device description, intended use, and claims substantial equivalence to predicate devices. However, it does not contain information related to specific acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, adjudication methods, multi-reader multi-case studies, or standalone algorithm performance in the sense typically associated with AI/ML-driven medical devices.

The document is for a physical water purification system, not a software algorithm, and therefore the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" as defined in the prompt (e.g., related to sensitivity, specificity, PPA, NPA, expert adjudication, training/test sets, etc.) are not applicable here.

Instead, for this type of medical device, "acceptance criteria" would refer to its ability to meet water quality standards (e.g., AAMI standards for hemodialysis water) and "proof" would be through engineering specifications, performance testing of the physical components, and comparison to existing predicate devices. The document explicitly states:

"Virginia Water systems claims equivalence in terms of technological characteristics, including design, material, chemical composition, and energy source as the predicate devices."

Therefore, I cannot extract the requested information because it is not present in the provided text.

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