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The AmeriWater Ozone Disinfection System is an optional accessory for the AmeriWater Bicarb Solution Mix and Distribution System (SDS) cleared for market under K051031 and the AmeriWater Water Purification System (WPS) for Hemodialysis cleared for market under K991519. It is intended for use in hospitals and dialysis clinics for the disinfection of the AmeriWater SDS and WPS system. The disinfection process is completed during off-hours when the SDS or WPS are not being used for patient treatment. The AmeriWater Ozone Disinfection System provides dissolved aqueous ozone concentrations of at least 0.5 ppm with a contact time of at least 30 minutes for disinfection of the WPS and SDS systems (the entire disinfection process takes approximately 2 hours to complete and longer contact times may be necessary based on microbial loads). The Ozone Disinfection System is designed to produce water with a microbial count of 50 CFU/ml or less.

The AmeriWater Ozone Disinfection System is a compact portable device that connects to the AmeriWater Bicarb Solution Mix and Distribution System (SDS) and the AmeriWater Water Purification System (WPS) for Hemodialysis for disinfection of the systems. Microbial reduction is achieved by a combination of disinfection by ozone and by physical removal by draining, flushing, and refilling the system being disinfected with fresh water. The Heatsan system has been designed to be in compliance with the requirements of ANSI/AAMI/ISO 13959:2009 Water for hemodialysis and related therapies and ANSI/AAMI/ISO 26722:2009 Water treatment equipment for hemodialysis applications and related therapies.

The AmeriWater Ozone Disinfection System uses a high technology corona discharge process for producing ozone. Ozone is manufactured by drawing oxygen (O2) into the ozone generator and exposing it to multiple high voltage electrical discharges. This causes a percentage of the oxygen molecules to dissociate and reassemble as ozone (03). The ozone is drawn into the water by a venturi injector / mixer allowing the ozone to be injected into the water under a vacuum condition. The AmeriWater Ozone Disinfection System is a complete unit with ozone generator, venturi injector mixer, gas off chamber with excess ozone gas destruct, feed water flow meter, oxygen flow meter, and vacuum gauge.

The driving force of the AmeriWater Ozone Disinfection System is the distribution pump on the WPS water loop and the mix and distribution pumps on the SDS. A valve arrangement installed on the outlet of the WPS distribution pump and the SDS pumps allow for the diversion of purified water flow into the AmeriWater Ozone Disinfection System and back into the SDS or WPS storage tanks. The pumps force the purified water from the WPS storage tank into the Ozone Disinfection System, which enriches it with ozone and returns it to the WPS storage tank. Likewise, the purified water from the SDS mix and distribution tanks is pumped into the Ozone Disinfection System where it is enriched with ozone and returned to the tanks. When the water flow has been adjusted properly, a vacuum will draw oxygen (from a medical grade oxygen source) into the ozone generator and ozone will be created. The ozone generator has a vacuum switch and will not operate without an adequate vacuum from the venturi injector as indicated on the Ozone Disinfection System vacuum gauge.

The purified water from the WPS or SDS flows into the Ozone system through the feed flow meter and into a venturi injector creating a vacuum that draws the oxygen through the generator creating ozone in concentrations greater than 0.5 ppm. The ozone is then mixed in the ozone rich water enters the gas off tank to remove any excess, un-dissolved ozone gas. The water-ozone mixture enters and exits at the bottom of the gas off tank. The excess (un-dissolved) ozone will slowly displace the water in the tank and is vented at the top of the tank. The excess ozone gas then enters the ozone destruct chamber where it is destroyed while the ozone-rich water is directed back to the system being disinfected. Ozone concentrations are monitored using RPC Ozone Test strips, cleared for market under K132344.

The intended disinfection endpoint for the AmeriWater Ozone Disinfection System with the AmeriWater Water Disinfection System (WPS) and the AmeriWater Solution System (SDS) following disinfection and rinse is a total bacterial count less than or equal to 50 CFU/mL; when the system being disinfected is properly maintained (with bacterial counts

The AmeriWater Ozone Disinfection System is designed to disinfect the AmeriWater Bicarb Solution Mix and Distribution System (SDS) and the AmeriWater Water Purification System (WPS) for Hemodialysis. The overall goal is to produce water with a microbial count of 50 CFU/ml or less.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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The AmeriWater MRO Portable Reverse Osmosis Systems are water treatment systems intended for use in hemodialysis applications. They are designed to pre-treat and purify potable water for use in making dialysate for hemodialysis and to meet current AAMI and Federal (U.S.) standards. The AmeriWater Portable MROS model is intended for use in a hospital, clinic, dialysis center, or for home care for single patient use. The AmeriWater Portable MRO1 model is for treatment of up to two patients in a hospital, clinic, or dialysis centers.

Osmosis is a natural process where two liquids of different concentration are separated by a semi-permeable membrane and the liquid moves from the lower concentration to the higher concentration in order to achieve chemical equilibrium. Reverse osmosis, the scientific concept used in the AmeriWater MRO Portable Reverse Osmosis System, is the opposite of osmosis. Liquid is forced from a region of higher solute concentration through a semi-permeable membrane to a region of lower solute concentration. This is achieved by applying a pressure in excess of the osmotic pressure. Osmotic pressure is the pressure which needs to be applied to a solution to prevent the inward flow of water across a semi-permeable membrane. The MRO system uses a submersible pump to apply the pressure required for reverse osmosis.

The semi-permeable membrane used in the MRO system is a thin film composite (TFC) membrane. A TFC membrane is essentially a molecular sieve constructed in the form two or more layered materials. The membranes are made out of polyamide, chosen for its permeability to water and relative impermeability to various dissolved impurities and unfilterable molecules.

The MRO Portable Reverse Osmosis System purifies tap water by applying pressure (greater than the osmotic pressure difference) to the feed water supply in order to reverse the water flow through the semi-permeable reverse osmosis membrane so that the water moves from a more concentrated solution to a less concentrated solution resulting in purified permeate flow. Basically, the tap water is supplied to the MRO pump where ist is pressurized and sent to the membrane splits the tap water into permeate, which has passed through the membrane, and the concentrate, which passes over the membrane and carries the contaminants to drain. The AmeriWater MRO Reverse Osmosis System produces water that meets ANSI/AAMI RD62 requirements for water used in hemodialysis applications. It provides quiet operation for bedside use and may be used for acute care cases, small dialysis wings in a hospital, or for home care. Materials that contact the product water include: ABS, Acrylic, Carbon, Nylon, PVC, Polyester, Polyethylene, Polypropylene, Stainless Steel, Tygon, EPDM, Viton, and Buna N.

Tap water enters the AmeriWater MRO Portable Reverse Osmosis System and passes through dual carbon block filters to remove chlorine, chloramines, and sediment which may damage the RO membranes. The dual chloramine removal carbon cartidges are a special blended carbon that salisfies AAMI and CMS requirements. Rated at 1 micron, the filters have a capacity of 8000 gallons with 3 PPM of chloramine at 9.5 pH. The submersible RO pump then pressurizes the feed water to pressures greater than the osmotic pressure. The pressurized feed water is sent through the RO membranes where contaminants are removed, and the feed water is split into permeate, or product water, and concentrate, or reject water. The purified permeate water passes through a Nephros Dsu filter capsule (K110285) to remove microbiological contaminants (down to 0.005 microns) and then is directed to the point of use. A portion of the reject water is returned to the RO pump to reduce waste, and the remainder is sent to drain. Optional antiscalant (K991519) may be included for use on un-softened water supplies to remove hardness minerals that may scale the membrane.

The AmeriWater MRO Portable Reverse Osmosis System includes safety features for the user and to protect patient safety. The safety features meet current and include product water conductivity monitor with audible alarm, a low -pressure cut-off switch to prevent damage to the RO pump in low pressure situations, and a divert to drain feature that prevents product water with conductivity above the alarm set point limit from being used for patient treatment. The MRO also includes a simple disinfection procedure using hydrogen peroxide/peroxyacetic acid (PAA).

This document describes the AmeriWater MRO Portable Reverse Osmosis System, a water purification system for hemodialysis. However, the provided text does not contain information about specific acceptance criteria, a study proving device performance against those criteria, or details regarding sample sizes, expert involvement, or comparative effectiveness studies (MRMC, standalone). It primarily functions as a 510(k) Summary and FDA clearance letter, focusing on device description, intended use, and substantial equivalence to predicate devices.

Therefore, many of the requested elements cannot be directly extracted from the provided text. I will address the points that can be gleaned from the document and explicitly state where information is missing.

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the device "produces water that meets ANSI/AAMI RD62 requirements for water used in hemodialysis applications" and "meet current AAMI and Federal (U.S.) standards." It also mentions specific performance characteristics related to filtration and microbiological contaminants. However, it does not provide a table outlining specific acceptance criteria values (e.g., maximum allowable conductivity, minimum removal rates for specific contaminants) nor detailed reported device performance values against these criteria.

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided in the document. The text is a 510(k) summary, which generally focuses on substantial equivalence rather than detailed clinical or performance study results with specific sample sizes.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A MRMC comparative effectiveness study is not mentioned or implied in the document. The device is a water purification system, not an imaging or diagnostic AI requiring human reader interaction.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

While the device operates "standalone" in the sense that it performs water purification automatically, the document does not describe a specific "standalone study" with detailed results in the context of the prompt's likely interpretation (e.g., an AI algorithm's performance vs. a human's). The performance evaluation is implied to be against chemical and microbiological standards.

7. Type of Ground Truth Used

The ground truth for this device's performance would be:

• Chemical and microbiological analysis: Water quality measurements (e.g., conductivity, levels of specific contaminants, microbiological counts) compared against established standards like ANSI/AAMI RD62. This is implied by the statements that the device "produces water that meets ANSI/AAMI RD62 requirements" and "removes microbiological contaminants."

8. Sample Size for the Training Set

This information is not provided in the document. The device is a physical water purification system, not an AI model that typically requires a "training set" of data in the common sense. Its "training" would be its engineering design and manufacturing processes to achieve the desired water quality.

9. How the Ground Truth for the Training Set Was Established

As noted above, a "training set" in the context of an AI algorithm is not applicable here. The "ground truth" for the device's design would stem from the engineering specifications and regulatory requirements (like AAMI standards) for hemodialysis water quality. The design and construction of the system are based on established scientific principles of reverse osmosis, filtration, and disinfection to achieve these standards.

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The Aqua Pure DI exchange tanks are used according to current AAMI standards (RD 62) and are intended to supply dialysis grade water, for use in dialysis, concentrate preparation systems, dialyzer reuse systems and rinsing of sterilants. The exchange tanks can be used for either primary water purification or to supply emergency backup water purification for dialysis units. The D.I. exchange tanks for dialysis are only one part of a complete water treatment system and must be used in conjunction within a water treatment system with appropriate pre-treatment and post-treatment.

Aqua Pure's D.I. Exchange Tanks for Dialysis are FRP tanks filled with mixed bed resin. Widget connectors are used in conjunction with a machined PVC schedule 80 head, stand pipe, fill port, and distributor basket. Our tanks are designed to supply AAMI standard water for dialysis through ion exchange. The D.I. exchange tanks are based on the Ameriwater Dialysis Deionizer Exchange Tanks K991519.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Aqua Pure D.I. Exchange Tanks for Dialysis (K072158).

Summary of Findings:

The provided 510(k) relies on substantial equivalence to a predicate device (Ameriwater Dialysis Deionizer Exchange Tanks, K991519) rather than a direct performance study with acceptance criteria. This means the device is deemed acceptable because it is designed to be functionally identical to a previously approved device. Therefore, a traditional "study proving the device meets acceptance criteria" as might be seen for a novel device with new performance claims, is not present.

Acceptance Criteria and Reported Device Performance

Study Details (As Per 510(k) Substantial Equivalence Process):

Since this is a substantial equivalence submission, the "study" is effectively a comparative analysis against the predicate, not a performance study in the typical sense.

1. Sample size used for the test set and the data provenance: Not applicable. There was no "test set" of performance data in the traditional sense, as the claim is based on identical design and materials to a device already deemed safe and effective. The provenance is the design specifications of the new device compared to the predicate device.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for performance was not established via expert review of a test set. Equivalence was established by comparing design specifications and indications for use.
3. Adjudication method for the test set: Not applicable.
4. 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: Not applicable. This is a medical device (water purification tanks), not an AI diagnostic or assistance tool.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not an algorithm.
6. The type of ground truth used: The "ground truth" here is the established safety and effectiveness of the legally marketed predicate device (Ameriwater Dialysis Deionizer Exchange Tanks, K991519), based on its design, materials, and intended use as assessed by the FDA. The submission demonstrates that the new device shares this "ground truth" by being substantively the same.
7. The sample size for the training set: Not applicable.
8. How the ground truth for the training set was established: Not applicable.

Conclusion:

The Aqua Pure D.I. Exchange Tanks for Dialysis gained 510(k) clearance by demonstrating substantial equivalence to a legally marketed predicate device. This means the FDA determined that the new device has the same intended use and the same technological characteristics (or different characteristics that do not raise new questions of safety and effectiveness) as the predicate device. Therefore, no new performance studies, clinical trials, or expert adjudications were required from the applicant to prove that the device meets specific performance acceptance criteria. The "study" was a detailed comparison of its components, materials, and intended use against the predicate device, which the FDA found to be sufficiently similar to allow market entry.

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The AmeriWater Portable RO+ Model MROS09 is a stand-alone water treatment system for use in hemodialysis applications. It is designed to pretreat and purify potable water for use in making dialysate for hemodialysis. The AmeriWater Portable RO+ with Onboard Pretreatment System is intended to be used in hospitals, clinics, home-care, and dialysis centers. It provides quiet operation for bedside use and may be used for acute care cases, small dialysis wings in hospitals, or to handle extra patients at dialysis centers.

The AmeriWater Portable RO+ Model MROS09 is a portable, stand-alone water treatment system for use in hemodialysis applications. It is designed to pre-treat and purify potable water for use in making dialysate for hemodialysis. The water treatment components for the AmeriWater Portable RO+ Model MROS09 consist of a temperature-blending valve, two backwashing carbon filters, regenerating water softener with brine tank, a micron prefilter, and a reverse osmosis membrane. The components are conveniently packaged in ABS cabinets designed to fit in a standard washing machine pan. All components are constructed of materials that meet FDA and/or NSF standards.

The provided text describes the AmeriWater Portable RO+ Model MROS09, a water purification system for hemodialysis. However, it does not contain information about specific acceptance criteria and a study proving the device meets those criteria in the way typically expected for a medical device efficacy trial (e.g., performance metrics like sensitivity, specificity, or adverse event rates). Instead, the document focuses on demonstrating substantial equivalence to existing devices.

Here's an analysis based on the information provided and addressing your specific points:

1. Table of Acceptance Criteria and Reported Device Performance

No explicit table of acceptance criteria with corresponding performance data (e.g., sensitivity, specificity, accuracy, or similar quantitative metrics) is provided in this 510(k) summary. The primary performance claim is that the device "is designed to produce water that meets or exceeds ANSI/AAMI RD62 requirements." And "Contaminants are removed from the water at a rejection rate greater than or equal to 94% to achieve product water that meets or exceeds ANSI/AAMI RD62 standards."

2. Sample Size for Test Set and Data Provenance

The document does not describe a "test set" in the context of an efficacy study as one might expect for a diagnostic or AI device. Instead, the "testing" described is related to the design and performance specifications of the component parts and the overall system's ability to meet industry standards. There is no explicit mention of a sample size (e.g., number of patients, water samples evaluated over a period) for a clinical or in-use performance test to confirm the acceptance criteria for the entire device.

The data provenance for the claims is largely implied to be based on the design specifications and testing performed by AmeriWater to ensure compliance with ANSI/AAMI RD62 standards and internal design parameters, as well as the proven performance of the predicate devices. This would be considered retrospective in the sense that it relies on established designs and standards, not a new prospective clinical trial. There's no country of origin of data explicitly stated, but it's an FDA submission, implying compliance for the US market.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided. The "ground truth" for this type of device is defined by engineering specifications and compliance with recognized industry standards (ANSI/AAMI RD62). It does not involve expert medical readers establishing ground truth for diagnostic decisions.

4. Adjudication Method for the Test Set

This is not applicable as there is no "test set" in the context of expert review or diagnostic assessment. Performance is measured against engineering specifications and documented compliance with standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done or is mentioned. This type of study is typically performed for diagnostic devices where human interpretation is involved, often comparing human performance with and without AI assistance. This device is a water purification system, not a diagnostic tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This concept is not applicable here. The device is a physical water purification system, not an algorithm. Its performance is measured by the quality of the water it produces, not by an algorithm's output.

7. Type of Ground Truth Used

The "ground truth" for this device's performance is established by engineering/design specifications and compliance with recognized industry standards, specifically ANSI/AAMI RD62 for water quality in hemodialysis. This also includes the proven performance of the predicate devices (K924695 and K991519) on which the new design's components are based.

8. Sample Size for the Training Set

This is not applicable. The device is a physical system, not an AI or machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This is not applicable for the same reason as above.

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