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The AMERIWATER PURIFICATION SYSTEM FOR HEMODIALYSIS is intended to be used in hemodialysis to remove organic and inorganic substances and microbial contaminants from water. Purified (or treated) water will then be used to prepare and dilute dialysate concentrate to form dialysate and/or rinse dialyzers for multiple use and/or to prepare and dilute solutions for reprocessing procedures in multiple-use dialyzers.

The AmeriWater Purification System for Hemodialysis is a water purification system designed and maintained to produce water of quality that consistently meets or exceeds AAMI Standards for water used in Hemodialysis and/or Dialyzer reuse. The components may include all or some of the following: Tempering valve Temperature Gauge Backflow Preventor Pressure Gauges Booster Pump Multi Media Filtration Carbon Filtration Water Softener Automatic Lockout 5 micron prefilter Reverse Osmosis Float & Pressure Control Return Flow Diffuser Storage Vessel Repressurization Pump(s) Deionization Submicron Filtration Distribution System PVC Pipe & Fittings PVC ball valves PVC labcock valves System Alarms. System design is determined by the design team following collection of information from the Customer Survey of Requirements, and complete chemical analysis of the waters to be treated. The system is complete with monitors and audible & visual alarms with remote activation in the area of patient care to notify staff of problems if they occur.

The provided text describes a water purification system for hemodialysis and its FDA 510(k) submission, confirming its substantial equivalence to predicate devices. However, the documentation does not contain any information regarding specific acceptance criteria, device performance data beyond its intended use, or details about a study to prove its compliance.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, nor can I provide information on sample sizes, ground truth establishment, or multi-reader multi-case studies, as this information is not present in the provided text.

The available information only states that the device is "designed and maintained to produce water of quality that consistently meets or exceeds AAMI Standards for water used in Hemodialysis and/or Dialyzer reuse." This is a general statement of intent regarding compliance with AAMI standards, but does not provide specific numerical acceptance criteria or performance data for the AmeriWater system itself.

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