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The Amerilyater MROZ Reverse Osmosis System is a water treatment device intended for use in hemodialysis applications. It is intended to be used as a component in the AmeriWater Water Purification System (K991519), and is intended to purify potable water for use in making dialysate for hemodialysis and to meet current AAMI and Federal (U.S.) standards. The AmeriWater MROZ is intended for use in water rooms in a hospital, clinic, or dialysis center. The device is intended to be a component in a complete water purfication system, and is not a complete water treatment system. It must be preceeded by pro-treatment devices, and may need to be followed by post-treatment devices as well to meet current AAM and Federal (U.S.) standards.

Model MRO3Z is a 3 membrane system designed to supply 6,600 gallons per day (gpd) of product water. Model MRO4Z is a 4 membrane system designed to supply 8,800 gpd of product water. Model MRO5Z Is a 5 membrane system designed to supply 11,000 gpd of product water. Model MRO6Z is a 6 membrane systems designed to supply 13,200 gpd of product water. Model MRO7Z is a 7 membrane system designed to supply 15,400 gpd of product water. Model MRO8Z is an 8 membrane system designed to supply 17,600 gpd of product water. Each model is available in a 208V, 230V, or 460V variant and includes a divert- to-drain feature to prevent patient exposure to unsafe product water. Each model includes temperature compensated online monitors that display conductivity and percent rejection. The conductivity monitor activates an audible and visual alarm when the product water conductivity exceeds a preset alarm limit.

The AmeriWater MROZ Reverse Osmosis System is a water treatment system intended for use in hemodialysis applications. The system is designed to remove organic and inorganic substances and contaminants from potable water. The purified (or treated) water will then be used to prepare and dilute dialysate concentrate to form dialysate. The AmeriWater MROZ Reverse Osmosis System is intended to be used in water rooms located in hospitals, clinics, and dialysis centers. There is no direct contact between the patient and any part of the device invasive. Materials that contact that contact the product water include: ABS, Acrylic, Nylon, PVC, Polyethylene, Polypropylene, Stainless Steel, Tygon, and Thin Film Composite Membrane (polyimide). The MROZ Reverse Osmosis System purifies water by applying pressure (greater than the osmotic pressure difference) to the feed water to reverse the water flow through a semi-permeable membrane so that the water moves from a more concentrated solution to a less concentrated solution resulting in purified permeate flow. Basically, the feed water is supplied to the membrane where it is split into permeate which has passed through the membrane and the concentrate which passes over the membrane and carries the contaminants to drain. The AmeriWater MROZ Reverse Osmosis System produces water that meets current AAMI and Federal (U.S.) standards for water used in hemodialysis applications.

This document describes the AmeriWater MROZ Reverse Osmosis System, a water treatment device intended for use in hemodialysis applications.

1. Table of Acceptance Criteria and Reported Device Performance

The device is intended to produce water that meets current AAMI and Federal (U.S.) standards for water used in hemodialysis. While specific numerical acceptance criteria for each contaminant level are not explicitly listed in this summary, the general performance criteria are:

2. Sample size used for the test set and the data provenance

The document states, "Non-clinical testing was conducted to verify and validate the performance of the reverse osmosis function." However, specific sample sizes for the test set and data provenance (e.g., country of origin, retrospective or prospective) are not provided in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This document describes a medical device for water purification, not an AI or diagnostic system that requires expert interpretation for ground truth. Therefore, this information is not applicable and not provided in the document. The "ground truth" for this device's performance would be the objective measurements of water quality parameters against established AAMI and Federal U.S. standards.

4. Adjudication method for the test set

This information is not applicable as the document describes objective performance testing of a physical device against established standards, not a diagnostic task requiring expert adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable as the device is a water purification system, not a diagnostic imaging or AI-assisted system that involves human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

This information is not applicable as the device is a water purification system and does not involve an algorithm with standalone performance in the context of AI.

7. The type of ground truth used

The ground truth for this device's performance is based on established objective physical and chemical measurements of water quality parameters as defined by current AAMI and Federal (U.S.) standards for water used in hemodialysis applications.

8. The sample size for the training set

This information is not applicable as the device is a physical water purification system and does not involve a "training set" in the context of machine learning or AI models. The design and performance are based on engineering principles and established water purification technologies.

9. How the ground truth for the training set was established

This information is not applicable for the reasons stated in point 8.

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