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The AmeriWater MediQA Reverse Osmosis System is one component of a water treatment system designed to pre-treat and purify potable water using reverse osmosis for making dialysate for hemodialysis applications. The device is intended to be a component in a complete water purification system, and is not a complete water treatment system. It must be preceded by pretreatment devices, and may need to be followed by post-treatment devices as well to meet current AAMI and Federal (U.S.) standards. The AmeriWater MediQA is intended for use in water rooms in a hospital, clinic, or dialysis center. The device includes an integrated heat sanitization process.

This Special 510(K) submission is for the addition of a new model to the AmeriWater MediQA Reverse Osmosis System product line originally cleared for market under 510(k) number K131904. The new model. MSP3HF is complementary to the rest of the product line and is not intended to replace or enhance features of any existing model.

The MSP3HF is a single pass reverse osmosis (RO) that uses pretreated soft water to produce water for hemodialysis applications. The system is capable of producing dialysis quality water at a flow rate up to 16.0 gallons per minute (gpm). The new model, like the predicate device, includes heat sanitization capabilities for the reverse osmosis system.

Model MSP3HF, is identical in design to the existing model MSP3 (K131904) with the exception of the RO pump. While model MSP3 includes a pump with a 20-stage impeller, the new model MSP3HF includes a pump with a 24-stage impeller (currently used on model MDP4). The increase in impeller stages results in the pump forcing more water through the existing membrane elements per unit time. Both the 20-stage pump and the 24-stage pump include the same pump motor. The increase in flow rate does not exceed the operating parameters of the membrane elements per the membrane manufacturer's specifications, and operating pressures remain the same as the predicate device. The increased flow rate does not change the product water quality (level of impurities), and the product water continues to meet all current AAMI/ISO and Federal requirements as confirmed by verification and validation testing. There are no changes to the software used in the device or to the water contacting materials. All software and materials used in the new model are identical to the predicate device.

The new model does not result in any changes to the heat sanitization process. The temperatures, contact times, and operating pressures remain the same as the predicate device. During the heat sanitization process, the heated water is recirculated through the MediQA system for the duration of the contact time. The flow path, operating pressure, water temperature, and contact time are identical between the predicate device and the new device during heat sanitization. There are no new issues regarding safety or effectiveness of the heat sanitization process.

The scientific concept for the operation of the AmeriWater MEDIQA Reverse Osmosis System is the principle of reverse osmosis. The MEDIQA system uses a pump (RO pump) to apply the pressure required for reverse osmosis. Pretreated soft water enters the MEDIQA through an inlet solenoid valve, filling the feed water tank. The RO pump forces water from the feed tank through the RO membrane elements. The water entering the RO membrane element exits the membrane element in two flow streams. The water forced through the RO membrane element is known as permeate water. It is purified water that meets all current AAMI/ISO and Federal requirements for water used in hemodialysis applications. The water rejected by the membrane contains an increased level of dissolved contaminants. It passes out of the RO module as the second flow stream called concentrate, and is sent to drain.

The built in heat sanitization feature provides heat sanitization of the reverse osmosis membranes and the MEDIQA system's pipe work. Heat sanitization can be activated manually using the HEATSAN buttons on the touch screen display or automatically if timer clock settings are implemented. The frequency of heat sanitization will depend upon usage and application demands. Monitoring of the system for bacterial content is required at regular intervals to determine the optimum frequency for heat sanitization.

This document describes the regulatory submission for the AmeriWater MediQA Reverse Osmosis System, Model MSP3HF. It is a Special 510(k) submission for the addition of a new model to an existing product line (K131904). The new model, MSP3HF, is largely identical to the predicate device, Model MSP3, with the primary difference being an upgrade to the RO pump to achieve a higher flow rate.

Here's an analysis of the acceptance criteria and supporting study details:

1. Table of Acceptance Criteria and Reported Device Performance

The submission doesn't explicitly list "acceptance criteria" in a tabulated format with pass/fail results for the new model MSP3HF in the same way one might expect for a novel device. Instead, it demonstrates substantial equivalence to a predicate device (MSP3) by showing that the new model meets the same performance standards and that the design change (pump upgrade) does not negatively impact safety or effectiveness. The implicit acceptance criteria are that the device continues to meet the requirements of relevant standards and functions as intended.

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

The document does not specify a "test set" in the context of individual patient data or a specific number of devices tested for the new model MSP3HF.

• For the original predicate device (K131904): Non-clinical testing was conducted to verify and validate performance. The details of samples used for these initial tests are not provided in this summary.
• For the new model (MSP3HF): Verification and validation testing was conducted. This included "complete system testing" where the device's performance was observed under various conditions. The sample size for this testing is implicitly "one device" (the MSP3HF model) or a representative number of units for its functional verification. The data provenance is internal testing by AmeriWater, LLC.

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

This information is not applicable as this is a medical device (water purification system), not an AI/imaging device requiring expert interpretation for ground truth. Technical performance against established industry standards is the primary assessment.

4. Adjudication method for the test set

This information is not applicable for the same reason as point 3.

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 this is a medical device (water purification system), not an AI/imaging device.

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

This information is not applicable as this is a physical medical device, not a software algorithm. The device operates autonomously to purify water.

7. The type of ground truth used

The "ground truth" for this device's performance is established by its ability to meet the specified performance parameters outlined in ANSI/AAMI/ISO 23500-1:2019 (for water quality) and ANSI AAMI ISO 23500-2:2019 and ANSI AAMI ISO 23500-3:2019 (for equipment and water standards for hemodialysis). Additionally, microbiological testing for the predicate device proved the effectiveness of the heat sanitization function.

8. The sample size for the training set

This information is not applicable as this is a physical medical device, not an AI/machine learning model that requires a training set.

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

This information is not applicable for the same reason as point 8.

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The AmeriWater Centurion 1500+ 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 AAM and Federal (U.S.) standards. The device is intended to be a component in a complete water purification system, and is not a complete water treatment system. It must be preceded by pre-treatment devices, and may need to be followed by post-treatment devices as well to meet current AAM and Federal (U.S.) standards. The Centurion 1500+ Reverse Osmosis System is intended for use in a hospital, clinic, dialysis center, or for home care for single patient use. The device includes an integrated heat sanitization process.

The AmeriWater Centurion 1500+ 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 Centurion 1500+ Reverse Osmosis System is intended to be used in hospitals, clinics, dialysis centers, and for home care use. There is no direct contact between the patient and any part of the device invasive. Materials that contact that contact the product water include: Nylon, Polypropylene, Stainless Steel, EPDM, and Thin Film Composite Membrane (Polyamide). The Centurion 1500+ 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. The feed water enters the Centurion through an inlet solenoid valve filling the feed water tank. A high pressure pump forces water from the feed tank through the RO 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 Centurion 1500+ Reverse Osmosis System produces water that meets current AAMI and Federal (U.S.) standards for water used in hemodialysis applications. The AmeriWater Centurion 1500+ Reverse Osmosis System also includes a built in heat sanitization feature. Heat sanitization can be activated manually using the HEAT SANITIZATION function from the controller's main menu. The frequency of thermal sanitization will depend upon usage and application demands. Monitoring of the system for bacterial content should be conducted at regular intervals to determine the optimum frequency for thermal sanitization.

The provided text describes a medical device, the "AmeriWater Centurion 1500+ Reverse Osmosis System," and its performance relative to existing standards and predicate devices. However, it does not describe an AI/ML powered medical device, nor does it contain a study with acceptance criteria related to typical AI/ML performance metrics (like sensitivity, specificity, AUC).

The document is a 510(k) summary for a Class II medical device, which is a water purification system for hemodialysis. The "acceptance criteria" and "study" mentioned in the document relate to the device's ability to purify water to specific physical, chemical, and microbiological standards, and its safety.

Therefore, many of your requested points are not applicable to the provided document. I will extract the information that is present and indicate where the requested information is not available due to the nature of the document.

Here's the breakdown based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document states: "The AmeriWater Centurion 1500+ Reverse Osmosis System produces water that meets current AAMI and Federal (U.S.) standards for water used in hemodialysis applications." and "Results of performance testing indicate that the device produces water that meets current AAM and Federal (U.S.) standards. Microbiological testing results show evidence that the heat sanitization function is effective in the reduction of bacteria. Clinical studies show evidence that the device, when used in accordance with the instructions for use, will produce water that meets current AAMI and Federal (U.S.) standards for hemodialysis."

The table provided in the document compares the new device with predicate devices across several specifications, which could be interpreted as performance metrics. The implicit acceptance criteria are that the device meets AAMI and Federal (U.S.) standards for water used in hemodialysis applications. The table below presents the comparative performance aspects mentioned.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not explicitly stated for specific tests (e.g., how many water samples, how many bacteria cultures). The text refers to "Non-clinical testing" and "Microbiological testing" and "Clinical studies" generally.
• Data Provenance: Not specified.
• Retrospective/Prospective: Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable: This document concerns a physical device that purifies water, not an AI/ML algorithm that interprets medical images or data requiring expert human-established ground truth. Water quality standards (AAMI, Federal U.S. standards) are objective chemical and microbiological measurements, not expert consensus opinions.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable: Adjudication methods like 2+1 or 3+1 are typically used for reconciling disagreements among human experts in cases where subjective interpretation is involved, common in image review. This is not relevant for objective water quality testing.

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

• Not Applicable: This is not an AI/ML device, so no MRMC study, human reader improvement, or AI assistance is relevant.

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

• Not Applicable: This is not an AI/ML algorithm. The device operates as a standalone water purification system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Ground Truth Type: Physical and chemical measurements against established AAMI and Federal (U.S.) standards for water used in hemodialysis. This includes specific limits for various contaminants (e.g., total dissolved salts, bacteria count) and functional parameters (e.g., permeate flow rates).

8. The sample size for the training set

• Not Applicable: This is not an AI/ML device that requires a "training set." The device is engineered and then tested against established physical standards.

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

• Not Applicable: No training set or associated ground truth as this is not an AI/ML device.

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The AmeriWater MediQA Reverse Osmosis System is one component of a water treatment system designed to pre-treat and purify potable water using reverse osmosis for making dialysate for hemodialysis applications. The device is intended to be a component in a complete water purification system, and is not a complete water treatment system. It must be preceded by pre-treatment devices, and may need to be followed by post-treatment devices as well to meet current AAMI and Federal (U.S.) standards. The AmeriWater MediQA is intended for use in water rooms in a hospital, clinic, or dialysis center. The device includes an integrated heat sanitization process.

Reverse osmosis, the scientific concept used in the AmeriWater MEDIQA Reverse Osmosis System, is the opposite of osmosis. The MEDIQA system uses a pump to apply the pressure required for reverse osmosis. Potable tap water enters the MEDIQA through an inlet solenoid valve filling the feed water tank. A high pressure pump forces water from the feed tank through the RQ modules, each module containing a high performance membrane. The water entering the RO module is split into two flows. The water which passes through the membrane is known as permeate and is purified water. The water rejected by the membrane contains an increased level of dissolved contaminants. It passes out of the RO module as the second flow stream called concentrate, and is sent to drain.

The MEDIQA is available as a single pass or a double pass reverse osmosis (RO) unit. In a double pass (two RO stages) system, permeate from the first stage is pressurized by a second high pressure oump and fed to the second stage RO module set. Permeate from the second stage RO module set is fed via a manifold to the distribution loop. Unused permeate returning from the distribution loop is fed back into the feed tank. The concentrate from the first stage is sent to drain while the concentrate from the second stage is returned to the feed water tank for reprocessing. The feed and permeate water flows are monitored at various points in the process to verify temperature, conductivity, and flow. This data is displayed on a touch screen panel to give instant feedback of water quality and process activity. The MEDIQA system is controlled and operated by a touch screen mounted on the machine.

The AmeriWater MEDIQA Reverse Osmosis System also includes a built in heat sanitization feature to enable a heat sanitization of the reverse osmosis membranes and its pipe work. Heat sanitization can be activated manually using the HEATSAN buttons on the touch screen display or automatically if timer clock settings are implemented. The frequency of heat sanitization will depend upon usage and application demands. Monitoring of the system for bacterial content should be conducted at regular intervals to determine the optimum frequency for heat sanitization.

The provided text describes the AmeriWater MediQA Reverse Osmosis System, a water purification system for hemodialysis. The document is a 510(k) summary for premarket notification to the FDA.

Here's an analysis of the provided information, focusing on acceptance criteria and study details:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in a table format with specific quantifiable targets for the performance parameters. Instead, it describes the intended performance in comparison to standards and the predicate device.

However, based on the "Summary of Performance Testing" and the "Statement of Substantial Equivalence," we can infer the following performance goals and reported outcomes:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state the specific "sample size" for physical units of the device tested, nor does it detail the specific "country of origin of the data" or whether the studies were "retrospective or prospective."

It refers to "Non-clinical testing" and "Clinical studies."

• Non-clinical testing: This likely involved laboratory testing of the device performance, including the RO function and heat sanitization efficacy.
• Clinical studies: These "show evidence that the device, when used in accordance with the instructions for use, will produce water that meets current AAMI and Federal (U.S.) standards for hemodialysis." This suggests human use or simulation to verify the output water quality under real-world conditions, but no details on patient numbers or study design are provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. The document describes tests against established standards (AAMI and Federal (U.S.) standards for water quality) rather than relying on expert consensus for a ground truth in the typical sense of medical imaging or diagnostic studies. The evaluation of microbial reduction, for example, would likely follow standardized microbiology testing protocols.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable and not mentioned in the document. The device's performance is measured against objective physical, chemical, and microbiological standards, not subject to human interpretation requiring 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 is not applicable and not mentioned. The device is a water purification system, not an AI-powered diagnostic or assistive tool for human readers.

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

This is not applicable and not mentioned. The device performs a physical process (reverse osmosis and heat sanitization), and its performance is evaluated by measuring the quality of the water it produces, not by an algorithm's output.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the device's performance is defined by established regulatory and industry standards:

• Current AAMI (Association for the Advancement of Medical Instrumentation) standards for hemodialysis water quality.
• Federal (U.S.) standards for hemodialysis water quality.
• Microbiological testing protocols to determine bacterial reduction efficacy of heat sanitization.
• Biocompatibility, software validation, and electrical safety standards relevant to medical devices.

8. The sample size for the training set

This is not applicable and not mentioned. The AmeriWater MediQA Reverse Osmosis System is a physical medical device, not an AI/machine learning algorithm that requires a "training set."

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

This is not applicable as there is no training set for this type of device.

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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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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 USFilter/lonpure Med-RO™ Reverse Osmosis System is intended to supply water for use in the preparation of dialysate for hemodialysis patients and for other hemodialysis-related procedures such as cleaning, rinsing of equipment, and reprocessing of dialyzers. The water produced will meet the minimum water quality requirements as specified by ANSI/AAMI American National Standard for Water Treatment Equipment for Hemodialysis Applications RD 62:2001[RD-5: 1992 if Treatment Equipment for Temodiarysle Applications RD & LES T.(RE ST 1000 in conjunction with other components of a water treatment system as necessary with compatible input and output water requirements.

The Med-RO™ Reverse Osmosis System is a machine used to purify water.

The provided text describes a 510(k) submission for a medical device called the "Med-RO™ Reverse Osmosis System." This submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with acceptance criteria and performance metrics in the way one might find for a diagnostic or therapeutic device.

Here's an analysis of the provided text in relation to your request:

Acceptance Criteria and Reported Device Performance

The concept of "acceptance criteria" and "reported device performance" as typically seen in clinical trials for diagnostic algorithms is not explicitly present in this document. The submission is for a water purification system used in hemodialysis. For such devices, acceptance criteria would likely relate to specific water quality parameters (e.g., conductivity, levels of specific contaminants) and performance would be measured against those parameters.

The closest the document comes to this is in the "Indications For Use" section, which states: "The water produced will meet the minimum water quality requirements as specified by ANSI/AAMI American National Standard for Water Treatment Equipment for Hemodialysis Applications RD 62:2001 [RD-5: 1992 if Treatment Equipment for Temodiarysle Applications RD & LES T.(RE ST 1000 in conjunction with other components of a water treatment system as necessary with compatible input and output water requirements."

Therefore, the acceptance criteria for this device are implicitly tied to the ANSI/AAMI standards for water quality in hemodialysis. The document does not report specific measurements of water quality from the Med-RO™ system in a table format. It states that non-clinical tests were performed and that "Based on the testing performed as well as the information provided, there are no changes in the performance, safety or effectiveness of the modified device." This implies that the device meets the functional requirements for water purification, and thus, by extension, the ANSI/AAMI standards, but no concrete data is presented here.

Table of Acceptance Criteria and Reported Device Performance:

Study Information as per Request:

1. A table of acceptance criteria and the reported device performance
   (See table above. Specific numerical data is not provided in the document.)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • N/A. The document explicitly states "Discussion of Clinical Test Performed: N/A." This indicates that no clinical test set was used for evaluating the device's performance in humans. The testing mentioned is "non-clinical." The submission is based on engineering design and performance verification, demonstrating that the modified device performs equivalently to the predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

   • N/A. There was no clinical test set, and therefore no ground truth established by medical experts in this context. The "ground truth" for a water purification system would be the objective measurement of water quality against established engineering and medical standards (like ANSI/AAMI), not expert consensus on medical images or diagnoses.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

   • N/A. No clinical test set.

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

   • N/A. This device is a water purification system, not an AI-assisted diagnostic or therapeutic tool for human readers.

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

   • N/A. This is not an algorithm. The "standalone" performance here would refer to the Med-RO™ system's ability to purify water independently. The submission indicates non-clinical testing was done to verify this, but details of those tests are not provided in this summary.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

   • The "ground truth" for this device's performance would be the direct measurement of water quality parameters (e.g., conductivity, total dissolved solids, specific ion concentrations, microbiological counts) against the specifications set by the ANSI/AAMI American National Standard for Water Treatment Equipment for Hemodialysis Applications RD 62:2001 (or RD-5:1992).

8. The sample size for the training set

   • N/A. This is not an AI/ML device that requires a training set.

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

   • N/A. Not an AI/ML device.

Summary of the Study (as described in the document):

The submission describes a non-clinical study (or more accurately, a comparison based on non-clinical testing and engineering assessment) to demonstrate substantial equivalence of the Med-RO™ Reverse Osmosis System to a previously cleared predicate device (USFitter/lonpure, Inc. M-Series Reverse Osmosis Water Purification System).

The primary "study" performed was an engineering assessment and non-clinical testing to ensure that modifications to the device "will not negatively affect performance, safety, or effectiveness." The core argument for substantial equivalence is that the new device "contains the same fundamental scientific technology as the predicated device."

The study did not involve human subjects or clinical data in the manner often seen for diagnostic or therapeutic devices. Its "acceptance criteria" are implied to be adherence to the performance and safety characteristics of the predicate device and the relevant ANSI/AAMI water quality standards for hemodialysis. The document explicitly states "Discussion of Clinical Test Performed: N/A."

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A ZyzaTech Portable, V, Z or T Series Reverse Osmosis System and its pretreatment and product water distribution components is intended for use with a hemodialysis system to remove organic and inorganic substances and microbial contaminants from water that is used to dilute dialysis concentrate to form dialysate, and to produce purified water for other purposes such as dialyzer reprocessing and equipment rinse and disinfection.

The ZyzaTech series RO systems purify feed water through reverse osmosis which is the opposite of osmosis. Osmosis is the natural process wherein concentrated and dilute solutions, separated by a semipermeable membrane, flow to equalize concentrations. Solvent will flow from the dilute to the concentrated side of the membrane creating equal levels of concentration. Reverse osmosis is the application of high hydrostatic pressure on the concentrated solution; the direction of flow is reversed so that high solute concentrations flow across a semi-permeable membrane and become dilute concentrations. This results in two streams of water; one that is purer than the feed water, and the other that is higher in concentrates than the feed water. The pure flow is product water. The high concentrate flow is waste water.

The purpose of a pretreatment section of the system is to remove chlorine/chloramines and to condition the feed water supplying the RO unit. Conditioning the feed water can include: boosting the pressure, tempering, removal of particulates and, often, membrane scaling factors, along with volatile inorganic and organic solutes. The pretreatment section can include: feed water booster pumps, a temperature blend valve, chemical feed unit, cartidge filters, multi-media (sediment) filters, water softeners, dealkalizers and carbon filtration tanks.

The RO unit removes dissolved inorganic solutes with a molecular weight greater than 300, bacteria, viruses, endotoxins and particles. The primary elements of a RO unit are: a prefilter, RO pump and RO membranes housed in pressure vessels.

The purpose of a product water distribution section of a system is to deliver product water that meets AAMI standards to the points of use. Additional post-treatment measures are intended to control or eliminate bacteria prior to the points of use, especially in an indirect feed type of system. The product water distribution section can include: a storage tank, distribution repressurization pumps, distribution loop, UV irradiators, ultra and sub-micron filters.

Depending upon the series and model, ZyzaTech water purification systems produce typically from 250 gpd to 42,000 gpd of product water with a range of 17-75 percent recovery rate. Rejection of total dissolved solids (TDS) and monovalent and polyvalent ions is in the range of 95-99% depending upon feed water characteristics. Bacteria and pyrogens are rejected 99%. Organic size cut-off is a molecular weight greater than 300 Dalton.

ZyzaTech's water purification systems produce product water that meets the requirements of the voluntary standard issued by the American National Standard Institute and the Association for the Advancement of Medical Instrumentation: ANSI/AAMI RD5-1992, Hemodialysis Systems.

The provided text describes a 510(k) summary for the ZyzaTech Water Purification Systems, which are intended for use with hemodialysis systems. While the document outlines the device's function, intended use, and general performance claims, it does not contain the detailed study information typically found when evaluating acceptance criteria against specific scientific studies.

The document claims the device meets the voluntary standard ANSI/AAMI RD5-1992, Hemodialysis Systems, but it does not provide the specific acceptance criteria from that standard nor a detailed study report demonstrating compliance.

Therefore, much of the requested information cannot be extracted from the provided text. I will complete what is available and note what is missing.

Acceptance Criteria and Device Performance

The document states that ZyzaTech's water purification systems produce product water that meets the requirements of the voluntary standard ANSI/AAMI RD5-1992, Hemodialysis Systems. While the specific numerical acceptance criteria from that standard are not provided in the input text, the document does report general performance characteristics of the ZyzaTech systems.

Study Details (Information Not Available in the Provided Text)

The provided text is a 510(k) summary, which typically summarizes the equivalence to predicate devices rather than providing full study protocols and results for device performance against specific acceptance criteria. Therefore, the detailed study information requested below is not available within the input.

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Not provided. The document states general performance characteristics ("typically," "range of," "depending upon") but does not detail specific test sets or studies performed to arrive at these numbers.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • Not applicable/Not provided. This type of information is relevant for studies involving human interpretation (e.g., medical imaging diagnostics). For a water purification system's performance, ground truth would typically be established through analytical laboratory methods, not expert consensus on interpretations.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable/Not provided. As above, this is typical for studies involving human reviewers and diagnostic interpretations.

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/Not provided. This is a water purification system, not an AI-assisted diagnostic tool.

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

   • Not applicable/Not provided. This device is a physical water purification system, not an algorithm. Its performance is inherent to its mechanical and chemical processes, not an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • For water purification systems, ground truth is typically established by chemical and microbiological laboratory analysis of water samples before and after purification against established standards (e.g., AAMI RD5-1992 chemical limits, bacterial counts). However, the specific methodology is not detailed in the provided document.

7. The sample size for the training set:

   • Not applicable/Not provided. The device is a physical system, not a machine learning algorithm that requires a "training set." Its effectiveness is based on engineering design and physical principles.

8. How the ground truth for the training set was established:

   • Not applicable/Not provided. See the explanation for point 7.

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