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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 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 Heatsan is an optional accessory for water treatment systems intended for use in hemodialysis applications. The Heatsan is designed to heat water received from the water purification system, and circulate the heated water around the distribution loop at a controlled sanitizing temperature (minimum temperature of 185°F) for a programmed length of time (minimum hold time of 2 hours) to provide heat disinfection of the water distribution loop. The AmeriWater Heatsan is intended for use in hospitals, clinics, or dialysis centers to provide heat disinfection resulting in total viable microbial counts below 50 CFU/ml.

The AmeriWater Heatsan is intended for use in hospitals, clinics, or dialysis centers to provide heat disinfection resulting in total viable microbial counts below 50 CFU/ml. It is an integrated hot water disinfection unit that incorporates equipment to heat water received from a direct feed Water Purification System , and circulate around a distribution loop at a controlled sanitizing temperature of 185°F) for a specified length of time (minimum hold time of 2 hours). 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//SO 26722:2009 Water treatment equipment for hemodialysis applications and related therapies. The operation of the Heatsan unit is controlled entirely through the touch screen panel located on the front of the main control box. The touch screen displays systems performance data and the status of the device. The Heatsan unit incorporates monitoring devices and will report alarms and warnings messages via the user display. The Heatsan is used only during non-treatment hours when there are no patients being dialyzed. There is no patient contact with the device.

The unit can be configured to disinfect up to two distribution loops, either individually or together. The user can set for each day of the week which loop is to be disinfected and in what configuration. The Heatsan has been designed to provide up to 100 gallons of hot water for the purpose of sanitizing connected dialysis equipment. The number of machines that can be disinfected at any one time will be dependent on the requirement of those machines regarding the amount of water each machine needs for disinfection, the time taken to perform heat disinfection and the flow at which they require the hot water. When in "Dual" mode, sanitizing two distribution loops, the unit can potentially supply up to 200 gallons of water so that 100 gallons of water will be available for each distribution loop. Following disinfection of the first loop the unit will refill and reheat to disinfection temperature then proceed automatically to disinfect the second distribution loop.

The system allows the user to input the specific requirements of the dialysis machines to be disinfected, the days requiring heat disinfection and the times which heat disinfection can occur. If the system detects that any of the entered user values cannot be achieved by the Heatsan unit will raise an "Incorrect number" alarm warning the user that the parameters loaded cannot be achieved.

The Heatsan operation stages include Pre-heat. Heating, Hold, Water draw off, and Cool down. The typical stage duration times for disinfection are as follows: Pre-heat 120 minutes, Hold* 120 minutes, Water draw off 60 minutes, Cool down 60 minutes.

Here's an analysis of the provided text regarding the acceptance criteria and study for the AmeriWater Heatsan device, formatted to address your questions:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Microbiological Testing: "A total of three test runs were conducted with each organism." (This means 3 runs for Burkholderia cepacia and 3 runs for Mycobacterium abscessus).
• Data Provenance: Not explicitly stated as country of origin, but the testing was conducted to verify and validate the efficacy of the system in the reduction of bacteria in a water distribution system, simulating worst-case conditions. The study does not specify if it was retrospective or prospective but describes experimental runs, suggesting a prospective experimental design in a laboratory setting.

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

• This information is not provided in the document. The ground truth for microbiological effectiveness appears to be based on direct measurement of microbial reduction, not expert interpretation.

4. Adjudication Method for the Test Set

• This information is not applicable as the ground truth was established through direct microbiological measurement rather than expert review 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

• No, an MRMC comparative effectiveness study was not performed. This device is an automated heat sanitization system for water distribution loops, 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

• Yes, the microbiological performance study describes a standalone performance of the device (heat sanitization system). The system operates automatically to disinfect the water distribution loop.

7. The Type of Ground Truth Used

• For the microbiological performance, the ground truth was based on direct microbiological measurement of bacterial reduction (log reduction) in a water distribution system following an inoculation procedure.
• For biocompatibility, the ground truth was based on analytical testing for conductivity and total organic carbon (TOC) levels.
• For electrical safety, the ground truth was compliance with IEC 61010 standards verified by an ETL listing.
• For software, the ground truth was that the software performs as intended based on validation.

8. The Sample Size for the Training Set

• This device is a hardware system with software control for automated disinfection. It does not rely on a "training set" in the context of machine learning or AI algorithms that learn from data. Therefore, this information is not applicable.

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

• As mentioned above, there is no "training set" for this type of device. The system's operation is based on pre-programmed parameters and physical processes (heating, circulation), not learned patterns from a data set.

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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 Alarm Panel is intended for use in hospitals and dialysis clinics as an optional component in the AmeriWater Water Purification System (WPS) for hemodialysis applications. The AmeriWater Alarm Panel is intended to notify the operator of conditions that exist with the Water Purification System requiring the operator's attention. The AmeriWater WPS is intended to remove organic and inorganic substances and microbial contaminants from water. The 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 dilute solutions for reprocessing procedures in multiple-use dialyzers. The Alarm Panels are designed to meet current AAMI and Federal (U.S.) standards.

The AmeriWater Alarm Panel is designed to let technicians and nurses know when something is not functioning properly with the water equipment. The Alarm Panels warn the user by illuminating an alarm light and sounding an audible alarm, indicating that some limit has been exceeded. This submission is for a design change to the existing AmeriWater Alarm Panel cleared for market use in the AmeriWater Water Purification System (WPS) for hemodialysis applications (K991519). The AmeriWater Alarm Panel design has been upgraded from a panel with switches operating relays, to a digital panel operated by a microprocessor. All of the Alarm Panels are provided with an LCD display that will indicate the status of the water system. The nurse's station remote will correspond to what is indicated on the alarm panel. The selection of possible water properties to be monitored has been chosen during the original purchase of this equipment. The properties that this system can monitor include Low Resistivity, High Conductivity, R/O Alarm, Low Storage Tank, and Low Bicarb. There are also 5 additional dry contact inputs provided.

The AmeriWater Alarm Panel (K121022) is a Class II medical device intended to notify operators of conditions within the AmeriWater Water Purification System (WPS) for hemodialysis applications. It is an upgrade from a relay-based system to a microprocessor-controlled digital panel with an LCD display.

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes the device's functions and how it meets AAMI and Federal (U.S.) standards. However, it does not provide specific quantitative acceptance criteria or detailed numerical performance metrics in a tabular format. Instead, it offers a general statement of successful performance based on functional verification.

The table below summarizes the listed functionalities of the K121022 AmeriWater Alarm Panel compared to the predicate device (K991519) and the reported performance.

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

• Test Set Sample Size: "Each of the test units was bench tested." "100% of distributed product will be subjected to performance testing prior to shipment." While the exact number of units bench tested for this submission is not explicitly stated as a single number, it indicates that
  • performance testing was conducted on "initial production units representing the approved final design."
  • all possible features were tested on these units.
  • 100% of distributed product will undergo similar performance testing.
• Data Provenance: The testing was conducted in-house by AmeriWater as part of their design verification and validation process for a design change to an existing device. It is therefore prospective for the new design. The document does not specify a country of origin for the data other than the company being based in the USA.

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

• The document does not mention the use of external experts or a formal "ground truth" establishment by experts for the performance testing.
• The testing was focused on verifying the device's functional operation against its design specifications and AAMI requirements. This suggests that internally defined technical specifications and AAMI standards served as the "ground truth" or reference for performance.

4. Adjudication method for the test set:

• No adjudication method (e.g., 2+1, 3+1) is mentioned as the testing performed was functional verification against design specifications and AAMI standards, not subjective assessment requiring multiple adjudicators.

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:

• No MRMC comparative effectiveness study was done for this device. This device is an alarm panel for a water purification system, not an imaging or diagnostic AI-assisted device that would involve human "readers" or AI assistance in interpretation.

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

• This device is not an AI algorithm. It is a microprocessor-controlled alarm panel. The "standalone" performance in this context refers to the device's ability to accurately detect and signal conditions according to its programming and sensor inputs, which was verified through bench testing. The software validation was conducted for a moderate level of concern, indicating the algorithm (control logic) was tested without human intervention in its core alarm triggering functionalities.

7. The type of ground truth used:

• The ground truth used was based on:
  • Design Specifications: The intended operational parameters and alarm thresholds defined during the design phase of the AmeriWater Alarm Panel.
  • AAMI Standards: Compliance with current AAMI (Association for the Advancement of Medical Instrumentation) standards for water purification systems for hemodialysis.
  • Known Standards for Sensor Accuracy: For conductivity and resistivity monitors, comparison to "a known standard over the operation ranges expected" served as the ground truth for their accuracy.

8. The sample size for the training set:

• This device is a hardware device with embedded software (microprocessor-controlled). It does not employ machine learning or AI algorithms that require a "training set" in the conventional sense of data-driven model learning. The software was developed and validated, not "trained."

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

• As there is no conventionally defined "training set" for this device, the concept of establishing ground truth for it does not apply in the context of machine learning. The software's logic and parameters are based on engineering design, AAMI standards, and the requirements for monitoring water quality in hemodialysis systems.

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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 AmeriWater Solution Mix and Distribution System for Hemodialysis is intended to be used in a hemodialysis facility to mix and deliver, to the point(s) of use, bicarbonate and acid solutions necessary for hemodialysis. Federal law restricts this device to sale by or on the order of a physician for use in hemodialysis applications.

AmeriWater Bicarb Mix and Distribution System, Models 00BC55-55, 00BC100-100, and 00BC100-200 (Dual Tanks): The AmeriWater Bicarb Mix and Distribution System for Hemodialysis is intended to be used in a hemodialysis facility to mix and deliver, to the point(s) of use, bicarbonate solutions necessary for hemodialysis. Federal law restricts this device to sale by or on the order of a physician for use in hemodialysis applications.

AmeriWater Solution Mixing System, Model 00BC100 (Single Tank): The AmeriWater Solution Mixing System is intended to be used in a hemodialysis facility to mix and deliver, to the point(s) of use, bicarbonate solutions necessary for hemodialysis. Federal law restricts this device to sale by or on the order of a physician for use in hemodialysis applications.

AmeriWater Acid Concentrate Distribution System, Models 00AS130, 00AS300, and 00AS500: The AmeriWater Acid Concentrate Distribution System is intended to be used in a hemodialysis facility to store and deliver, to the point(s) of use, acid concentrate solutions necessary for hemodialysis. Federal law restricts this device to sale by or on the order of a physician for use in hemodialysis applications.

AmeriWater Wallboxes for Dialysis: The AmeriWater Wallbox for Dialysis is intended to be used in a hemodialysis facility as the point of connection for purified water, bicarbonate, and acid solution, for use in hemodialysis applications. Federal law restricts this device to sale by or on the order of a physician for use in hemodialysis applications.

The AmeriWater Bicarb Mix and Distribution System utilizes purified water from the dialysis facility's water purification system to mix bicarbonate solution and to distribute the solution to the point(s) of use. The system features automatic fill and mix, high vortex pumped mixing action, lightly pressurized distribution, and efficient disinfection. A single tank version, the AmeriWater Solution Mixing System, is also available to mix solutions from concentrate.

The AmeriWater Acid Concentrate Distribution System is used to store and distribute the acid concentrate(s) required for hemodialysis to the point(s) of use. Solution stored in and distributed by the Acid Concentrate Distribution System is mixed prior to being transferred to the system. Lightly pressurized distribution and recirculation provides steady, consistent delivery.

AmeriWater Wall Boxes are recessed boxes located at the point(s) of use that are intended to provide acid, bicarb, and/or water connections for the dialysis machine fittings used in the hemodialysis facility. Wall boxes are available in several configurations. Wall dialysis machine fittings are professionally installed by AmeriWater.

I am sorry, but the provided text describes a medical device, the "AmeriWater Solution Mix and Distribution System for Hemodialysis," and its regulatory clearance (510(k) K051031). It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment. This document is a regulatory submission for substantial equivalence, not a scientific study report.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as that information is not present in the provided text.

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The AmeriWater Purification System for Hemodialysis is used 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 dialyzers. AmeriWater does not recommend nor endorse any other use for water treated with AmeriWater systems. AmeriWater further does not endorse any specific hemodialysis or reprocessing procedures or equipment.

The AmeriWater Purification System for Hemodialysis may include pretreatment components, reverse osmosis and/or deionization, post-treatment components, and a distribution system. All or some of the following components may be included in an AmeriWater Purification System for Hemodialysis based on the customer's needs: Tempering Valve, Float and Pressure Control, Temperature Gauge, Return Flow Diffuser, Backflow Preventor, Booster Pump(s), Multimedia Filter, Water Softener, Carbon Filtration, Micron Prefilter, Chemical Feed System, Reverse Osmosis, Pressure Gauges, Storage Vessel, Deionization, Submicron Filter, Distribution System, Distribution Pump(s), PVC Pipe and Fittings, PVC Ball Valves, PVC Labcock Valves, Automatic Lockout, and System Alarms.

System design is determined by the customer's needs and the water conditions at their facility. Components for the water system are selected based on a survey of the customer's requirements and a complete chemical analysis of the water to be treated. The system is complete with monitors and audible/visible alarms with remote activation in the area of patient care to notify staff of problems if they occur.

The AmeriWater Chemical Feed System is a pretreatment device that is designed to deliver chemicals to the city tap water in order to adjust various chemistries in the water. The chemical feed system is located at the front-end of a water treatment system and may be used for pH adjustment, or to mitigate certain water contaminants to help improve the performance of the complete water system.

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves a device meets specific acceptance criteria.

The document is a 510(k) summary for the AmeriWater Purification System for Hemodialysis. It describes the device, its intended use, and lists components that can be included. It also details the specific components for which this 510(k) submission (K021560) is seeking clearance, primarily the AmeriWater Chemical Feed System and the combination of various previously cleared Reverse Osmosis (RO) units with the AmeriWater system.

The core of the document is the FDA's determination of substantial equivalence (K021560) to legally marketed predicate devices, which allows the device to be marketed. This is a regulatory clearance process, not a report on a performance study with acceptance criteria.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, ground truth, or details about a comparative effectiveness study.

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