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UPT Series Medical Reverse Osmosis Water Treatment System is intended to be used to remove organic and inorganic contaminants from a tap water supply to dilute a dialysate concentrate for hemodialysis treatments, as well as for use for dialyzer reprocessing and dialysis equipment disinfecting and rinsing.

This System is for multi patient use, such as for a dialysis clinic or hospital serving multiple patients with a Central Water Purification System.

The UPT Series Medical Reverse Osmosis Water Treatment System and its components consisting of; pretreatment, reverse osmosis, post-treatment, and the product water distribution components, are designed to remove microbiological, organic, and inorganic contaminants from the tap water to supply dialysis machines for the preparation of dialysate solutions for hemodialysis treatments.

Pretreatment components can include a tap water boosting system, blending valve, sediment filtration, carbon removal filters, water softeners, and all the necessary interconnecting plumbing. The purpose of this part of the system is to ensure that properly conditioned water is supplied to the reverse osmosis machine to ensure its safe and trouble-free operation.

After the tap water has been pre-treated, it then enters the R.O. (reverse osmosis), where total dissolved solids are removed to pertinent water quality standards. This is accomplished by utilizing a membrane separation process, whereby the incoming water is separated into a product stream, and a concentrate stream. The molecular weight cut-off determines what and how many contaminants are passed through into the product stream. R.O.s used for this application typically remove 95-99% of all total dissolved solids and bacteria.

The post treatment and product water distribution part of the system is in place to store, provide additional purification if needed, and deliver the purified water to wherever needed. These components can include items such as a storage tank, final filters (for bacteria and endotoxins), and delivery pumps and controls. Some systems can also utilize an ultraviolet light for additional disinfection properties if needed.

Here's an analysis of the provided text regarding acceptance criteria and study information for the UPT Series Medical RO Water Treatment System:

Summary of Acceptance Criteria and Study Details from the Provided Document K250514

Based on the provided document, the K250514 submission is for a modification to an existing device (UPT Series Medical Reverse Osmosis Water Treatment System, primary predicate K151637), specifically a clarification to its Indications for Use. Therefore, the document explicitly states that no new verification or validation performance testing was required or conducted for this update.

The conclusion section states: "Inclusive of this labeling update, the UPT Series Medical Reverse Osmosis Water Treatment System continues to meet all of its established acceptance criteria that were based upon performance of the primary predicate device." This means that the acceptance criteria and the studies proving the device meets them were originally established and performed for the primary predicate device (K151637). This current submission is a reaffirmation that the existing device still meets those established criteria despite the minor labeling change.

Therefore, the requested information cannot be fully populated from this document for the K250514 submission itself, as it refers back to the original predicate device's evaluation.

Detailed Response based on the provided K250514 document:

1. Table of Acceptance Criteria and Reported Device Performance:

   Acceptance Criterion	Reported Device Performance (for K250514)
   Water purification standards for hemodialysis (e.g., removal of microbiological, organic, and inorganic contaminants)	"The UPT Series Medical Reverse Osmosis Water Treatment System continues to meet all of its established acceptance criteria that were based upon performance of the primary predicate device."
   Safe and effective operation for hemodialysis treatments.	"This demonstrates that the device function is as safe, as effective, and performs as well as the primary predicate device."

   Explanation: The document does not list specific numerical or qualitative acceptance criteria beyond general statements that the system meets established standards for hemodialysis water purification. It refers to the performance established for its primary predicate device (K151637).

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 applicable. "No verification or validation performance testing was required for this labeling update."
   • Data Provenance: Not applicable for K250514. The original studies would have been associated with the primary predicate (K151637).

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 as no new performance testing was conducted for K250514.

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

   • Not applicable as no new performance testing was conducted for K250514.

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 device is a water treatment system, not an AI-assisted diagnostic tool for human readers.

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

   • Not applicable. This device is a water treatment system, not an algorithm. However, the system itself operates in a standalone capacity to purify water (without human cognitive input in its core function). The functional performance evaluation related to water quality would constitute its "standalone performance." The current submission states this performance was previously established for the predicate device.

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

   • For the original predicate device (K151637), the ground truth for its performance would likely have involved chemical and microbiological analytical testing of the treated water to ensure it met relevant AAMI standards (e.g., ANSI/AAMI RD52, ANSI/AAMI EQ82) for hemodialysis water quality. The document does not provide details on the specific "ground truth" methods used for the predicate.

8. The sample size for the training set:

   • Not applicable. This device is a water treatment system, not an AI/machine learning algorithm that requires a training set.

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

   • Not applicable. This device is a water treatment system, not an AI/machine learning algorithm.

In conclusion, K250514 is a submission for a minor labeling change to an already cleared device. It explicitly states that no new performance testing was required or conducted. All acceptance criteria and proof of meeting those criteria refer back to the studies performed for the original primary predicate device (K151637). To get detailed information about the original acceptance criteria and validation studies, one would need to consult the 510(k) submission for K151637.

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AquaBplus: The AquaBplus is a modular reverse osmosis unit intended for use with hemodialysis systems to remove organic and inorganic substances and microbial contaminants from the water used for treating hemodialysis patients or related therapies. This device is intended to be a component in a complete water purification system and is not a complete water treatment system. The reverse osmosis unit must be preceded by pre-treatment devices, and may need to be followed by post-treatment devices as well, to meet current AAMI /ANSI/ISO and Federal (U.S.) standards.

AquaB LITE: The AquaB LITE is a modular reverse osmosis unit intended for use with hemodialysis systems to remove organic and inorganic substances and microbial contaminants from the water used for treating hemodialysis patients or related therapies. This device is intended to be a component in a complete water purification system and is not a complete water treatment system. The reverse osmosis unit must be preceded by pre-treatment devices, and mav need to be followed by posttreatment devices as well, to meet current AAMI/ANSI/ISO and Federal (U.S.) standards.

The AquaBplus and AquaB LITE are reverse osmosis (RO) water purification systems that use pretreated soft water to produce dialysis water for hemodialysis (HD) devices and for the preparation of dialysis concentrates.

The AquaBplus system is a modular system consisting of a base module that can be used on its own or in conjunction with other modules. AquaBplus is the base module. AquaBplus B2 is a second RO unit that can be added to increase the quality of dialysis water. AquaBplus HF is a flow heater unit that can be added to provide heat disinfection for the RingMain. The AquaBplus HF module can also supply hot product water to connected HD devices.

The AquaB LITE system is a basic version of the AquaBplus system. Like the AquaBplus, it is a modular system consisting of a base module that can be used on its own or in conjunction with other modules. AquaB LITE is the base module and B2 LITE is a second RO unit that can be added to increase the quality of dialysis water. AquaBplus HF is a flow heater unit that can be added to provide heat disinfection for the RingMain. The AquaBplus HF module can also supply hot product water to connected HD devices.

This document is a 510(k) Premarket Notification letter for the AquaBplus and AquaB LITE water purification systems, which are used for hemodialysis. The document summarizes the device, its intended use, and the performance data that supports its substantial equivalence to a predicate device.

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

Important Note: The provided document is an FDA 510(k) clearance letter and its associated summary. This type of document focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed results from a clinical or AI-driven study with specific acceptance criteria in the manner an AI/ML medical device might. The "performance data" sections focus on safety, general functionality, and adherence to relevant standards rather than a comparative effectiveness study with human readers or standalone AI performance. Therefore, many of the requested points regarding AI/ML study design (e.g., sample size for test/training sets, expert ground truth, MRMC studies) are not applicable or detailed in this type of submission.

The "device" in this context is a water purification system, not an AI/ML algorithm for image analysis or diagnosis.

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

The document does not present a formal table of "acceptance criteria" and "reported device performance" in the way one might for an AI/ML diagnostic device (e.g., sensitivity, specificity, AUC thresholds). Instead, the performance data section outlines the types of tests conducted to demonstrate that the device functions as intended and meets relevant standards to be deemed substantially equivalent. The acceptance criteria are implicitly meeting the specified standards and ensuring safety and effectiveness compared to the predicate.

• ISO 23500-1 (Preparation and quality management of fluids for haemodialysis and related therapies – Part 1: General requirements)
• ISO 23500-2 (Preparation and quality management of fluids for haemodialysis and related therapies – Part 2: Water treatment equipment for haemodialysis applications and related therapies)
• ISO 23500-3 (Preparation and quality management of fluids for haemodialysis and related therapies – Part 3: Water for haemodialysis and related therapies) | "Testing to demonstrate that the device meets the... standards." (Implicitly, the device did meet them to receive clearance.) |
  | Software | Conformance with IEC 62304 Edition 1.1 (Medical device software – Software life cycle processes) | "Software verification within this submission is provided in accordance with IEC 62304..." (Implicitly met requirements). |
  | Disinfection Validation| Validation of chemical and heat disinfection labeling in accordance with FDA guidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff" (17 March 2015). (Acceptance: Disinfection processes are effective as labeled.) | "Validation of chemical and heat disinfection labeling..." (Implicitly, the validation was successful). |
  | Functional Verification| Complete system testing to verify the performance (e.g., conductivity and temperature) and functional (e.g., operating modes and generated alarms) requirements of the device. (Acceptance: Device operates as per design specifications for various parameters and modes.) | "Complete system testing to verify the performance... and functional... requirements of the device." (Implicitly, the device performed as required.) |
  | Packaging | Packaging and transport verification according to ASTM D4169-16. (Acceptance: Packaging adequately protects the device during transport.) | "Packaging and transport verification according to ASTM D4169-16." (Implicitly, the packaging was found adequate.) |
  | Biocompatibility | Testing conducted in accordance with ISO 10993-1:2020 and FDA guidance. Endpoints evaluated: Chemical Characterization, Toxicological Risk Assessment, Cytotoxicity, Sensitization, Irritation, Material-Mediated Pyrogenicity, Hemocompatibility. (Acceptance: Materials in contact with dialysis water are biologically safe.) | "Biocompatibility testing was conducted... The following endpoints were evaluated to support the biological safety..." (Implicitly, the testing supported biological safety.) |
  | Electrical Safety & EMC| Electrical safety testing in accordance with ANSI/AAMI ES 60601-1:2005. Electromagnetic compatibility (EMC) in accordance with IEC 60601-1-2 Edition 4.0. (Acceptance: Device meets electrical safety and EMC requirements.) | "Electrical safety testing was conducted... EMC was conducted..." (Implicitly, the testing demonstrated compliance.) |
  | Software V&V | System software verification testing to demonstrate effectiveness and confirm operation, in accordance with IEC 62304 and various FDA guidance documents on software functions, OTS software, and cybersecurity. (Acceptance: Software performs effectively and reliably, and meets regulatory guidelines for medical device software.) | "System software verification testing was performed to demonstrate the effectiveness of the software and to confirm the operation of the device." (Implicitly, positive results, leading to clearance.) |

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 applicable in the context of this device's testing. There is no "test set" of patient data or images as would be seen for an AI diagnostic algorithm. The testing described is hardware and software functional testing, validation against standards, and biocompatibility testing. These are typically performed on a limited number of physical units or material samples.
• Data Provenance: Not applicable. The "data" here refers to test results from engineering and laboratory evaluations, not patient data.

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. The ground truth for a water purification system is defined by engineering specifications, international standards (e.g., AAMI/ANSI/ISO), and validated chemical/microbiological testing methods, not by expert medical interpretation of images or patient outcomes.

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

• Not applicable. This concept pertains to resolving discrepancies in expert labeling of data for AI/ML models.

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 done. This type of study is specifically relevant for AI-assisted diagnostic tools that interact with human readers (e.g., radiologists interpreting images). The AquaBplus/AquaB LITE are water purification systems; they do not involve human diagnostic interpretation.

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

• Not applicable. This device is not an AI algorithm. Its "performance" is its ability to purify water according to specified parameters and standards, which is assessed through direct measurement and functional testing, not an isolated algorithm.

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

• The "ground truth" for this device's performance is established by:
  • International and Federal Standards: ISO 23500 series, AAMI/ANSI. These define the acceptable parameters for water quality for hemodialysis.
  • Engineering Specifications: Designed conductivity, temperature, flow rates, and failure modes.
  • Validated Test Methods: Biocompatibility tests (e.g., ISO 10993), disinfection validation protocols, electrical safety, and EMC standards.
  • Predicate Device Performance: The predicate device serves as a benchmark for substantial equivalence.

8. The sample size for the training set

• Not applicable. There is no "training set" as this device does not use machine learning.

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

• Not applicable. As there is no training set for an AI/ML model, there is no ground truth established for one.

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The AQUAbase nX is intended for use with hemodialysis systems to remove organic and inorganic substances and microbial contaminants from the water used for treating hemodialysis patients. The AQUAbase nX is to be used at dialysis clinics or hospitals.

The AQUAbase nX is a reverse osmosis unit intended to be a component in a complete water purification system, and is not a complete water treatment system. This reverse osmosis unit must be preceded by pre-treatment devices. Whether a particular device is included in an individual water treatment system will be dictated by local conditions. The reverse osmosis unit may need to be followed by post-treatment devices as well.

The AQUAbase nX is designed to meet current AAMI/ISO and Federal (U.S.) standards.

The AQUAbase nX is a single stage reverse osmosis system. A graphical touchscreen allows access and monitoring of all operating parameters at any time. Customized parameters make a high water vield possible, even under poor raw water conditions. Raw water consumption is based solely on the end user's permeate needs. The touchscreen makes it possible for the user to monitor all production parameters as well as design every system function, including disinfection mode, individually and reproducibly.

The AQUAbase nX works on the reverse osmosis principle. Reverse osmosis describes the process of pressure-operated cross-filtration. Water flows at high pressure tangentially over a semipermeable membrane. As is the case with normal filtration, the system is cleaned by allowing one component (water) of the mixture to be separated to pass through the membrane with almost no hindrance, while other components (dissolved and undissolved water contents) are held back to a greater or lesser extent and leave the filtration unit in the concentrate flow. This is a purely physical separation process in the molecular range which does not change the components being separated either chemically, biologically or thermally.

The provided document is a 510(k) summary for the AQUAbase nX, a water purification system for hemodialysis. It details the device's characteristics, intended use, and comparison to a predicate device, along with performance data.

However, the information provided does not contain the details required to describe the acceptance criteria and study that proves the device meets the acceptance criteria in the context of an AI-powered medical device.

The document discusses "performance data" which includes:

• Biocompatibility testing (ISO 10993-1)
• Electrical safety and electromagnetic compatibility (EMC) testing (IEC 60601-1, IEC 60601-1-2)
• Software verification and validation testing (FDA Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" as well as the draft FDA guidance recently issued)
• Additional performance bench testing (ISO 23500-3 for performance, chemical and heat disinfection testing, bacterial count and endotoxins)

These are standard engineering and medical device performance tests. There is no mention of an AI algorithm, a test set for AI, ground truth establishment by experts, MRMC studies, or standalone AI performance.

Therefore, I cannot fulfill the request as the provided text does not contain any information about an AI component or a study proving an AI device meets acceptance criteria. The device described is a physical water purification system, not an AI-powered diagnostic or assistive tool.

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The RenaPure filter is a bacterial and endotoxin retentive filter intended for use in a centralized loop as the final step of a water purification cascade to provide standard dialysis water to machine servicing multiple patients. This filter is not intended to service as the sole means of water purification and therefore must be used in conjunction with other water treatment equipment.

The RenaPure filter is a 20" cartridge style filter in a polypropylene casing that contains dual-layered, 0.22 micron polyethersulfone (PES) pleated membranes which are separated by polypropylene screen layers. The PES membrane is charge modified with a positive charge coating, similar to the predicate device, that aids in removal of endotoxin by charge attraction. Filter configurations are based on an industry standard 222 header design with silicone O-rings at the open end of the filter and flat or fin end caps at the closed end. The filter cartridge is installed in a durable filter housing and operates in a dead-end mode. The filter is designed to remove bacteria and endotoxin from water used in hemodialysis with similar water flow characteristics as the predicate device. The filter provided non-sterile.

The provided text describes the regulatory clearance of the RenaPure Endotoxin Retentive Filter and includes a summary of non-clinical performance assessment, but it does not contain information about:

• Acceptance criteria expressed as specific quantitative thresholds for device performance.
• A comparative study with human readers (MRMC study) or effect sizes of AI assistance.
• Standalone algorithm performance.
• Sample sizes for test sets or training sets in the context of an AI/algorithm study.
• Data provenance, number of experts for ground truth, or adjudication methods for an AI/algorithm study.
• Ground truth type for training data.

The document focuses on the physical and functional performance of a medical device (a filter) through bench testing and biocompatibility assessment, not on the performance of a diagnostic AI algorithm.

Therefore, I cannot fulfill your request as the necessary information regarding acceptance criteria, study details, and AI performance metrics (including expert involvement, sample sizes, and ground truth establishment) is not present in the provided text.

The "Performance (bench) testing" section within the "Non-clinical Performance Assessment" is the closest to describing a study, but it lacks the specific details requested concerning acceptance criteria, ground truth, and expert involvement usually associated with AI algorithm evaluation.

What the document does state about performance assessment:

• Study type: Non-clinical bench testing.
• Tests performed:
  • Flow/Pressure Drop measurements
  • Endotoxin Retention
  • Bacterial Retention
  • Compatibility to Hot Water and Chemical Disinfections
  • Housing Fit tests
  • Compatibility with Deionized water
• Results: "Testing demonstrated that the RenaPure filter met the intended design requirements and will operate as a drop-in replacement to the predicate device."
• Biocompatibility: A series of biocompatibility tests, including exhaustive extraction and toxicological risk assessment, were performed. "All biocompatibility testing passed and the risk of any toxic leachates from the RenaPure filter were considered negligible."
• Ground Truth: For these physical device tests, the "ground truth" would be established by the physical measurements and chemical analyses themselves, validated against engineering specifications and regulatory standards. There are no "experts" in the sense of clinical readers establishing ground truth for perception tasks.

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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 AquaA water purification system is a modular reverse osmosis unit intended for use with hemodialysis systems to remove organic and inorganic substances and microbial contaminants from the water used for treating hemodialysis patients or related therapies. This device is intended to be a component in a complete water purification system, and is not a complete water treatment system. The reverse osmosis unit must be preceded by pre-treatment devices, and may need to be followed by post-treatment devices as well, to meet current AAMI/ANSI/ISO and Federal (U.S.) standards.

The AquaA system is a reverse osmosis (RO) water purification system that uses pretreated soft water to produce dialysis water for hemodialysis (HD) devices and for the preparation of dialysis concentrates. The AquaA system is a modular system consisting of a base module that can be used on its own or in conjunction with other modules. AquaA is the base module. AquaA2 is a second RO unit that can be added to increase the quality of dialysis water. AquaHT is a flow heater unit that can be added to provide heat disinfection for the RO system including membranes and ring main. The AquaHT module can also supply hot product water to connected HD devices. AquaUF is an ultrafiltration module for the AquaA system intended to improve dialysis water quality by retaining constituents such as endotoxins and bacteria.

This document describes the regulatory submission for the AquaA water purification system, not a study proving it meets specific acceptance criteria based on performance metrics such as accuracy, sensitivity, or specificity. The submission focuses on demonstrating substantial equivalence to a predicate device, AquaBplus (K133829), rather than presenting a performance study with detailed acceptance criteria and reported device performance in the typical sense for an AI/CADe device.

Therefore, many of the requested sections about specific acceptance criteria, sample sizes, expert adjudication, MRMC studies, or standalone performance are not applicable based on the provided text.

Here's an attempt to answer the questions based only on the provided text, while also noting when the information is not present:

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

The document does not provide a table of quantitative acceptance criteria (e.g., accuracy, sensitivity, specificity) with corresponding reported device performance values. Instead, the "acceptance criteria" are implied by the conformity to various standards and the successful verification of functional requirements and safety.

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

This information is not provided in the document. The testing described (functional verification, electrical safety, biocompatibility, etc.) appears to be device-centric testing rather than testing on a dataset with "test sets" in the context of AI/CADe. There are no mentions of specific patient data or provenance.

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 applicable and not provided. The AquaA is a water purification system, not a diagnostic device that relies on expert interpretation for ground truth.

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

This information is not applicable and not provided.

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 such study was mentioned or conducted. This is not an AI/CADe device.

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

This is not an AI/CADe device, so standalone algorithm performance is not applicable. The device's "performance" is its ability to purify water according to standards, which is inherent in its operation, not an algorithm's output.

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

The concept of "ground truth" as typically used in AI/CADe evaluations (e.g., for diagnostic accuracy) is not applicable here. The "truth" or verification for this device is based on:

• Conformity to established international and national standards (e.g., ISO, AAMI, ASTM).
• Results from various engineering and safety tests (functional, electrical safety, EMC, biocompatibility).
• Risk management evaluations.

8. The sample size for the training set

This is not an AI/CADe device, so the concept of a "training set" is not applicable.

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

Not applicable.

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The U9000 Plus Ultrafilter is indication of incoming water for dialysis fluid as well as purification of dialysis fluid to obtain standard dialysis fluid in accordance with international standards requirements and local regulations. The risk of exposure to bacteria and endotoxins can thereby be minimized. The U9000 Plus Ultrafilter is intended to be used in conjunction with a water treatment system.

WARNING! The U9000 Plus Ultrafilter can only be used with AK98 dialysis machines equipped with holder for an ultrafilter.

The Ultrafilter product family (U9000 Plus, and its predicate device U9000) are ultrafilters intended for water filtration (removal of pyrogens and microorganisms), and filtration of dialysis fluid. The risk of exposure to bacteria and endotoxins can thereby be minimized.

The U9000 Plus is intended to be used in conjunction with an upstream water treatment system. The Ultrafilter U9000 Plus can only be used with AK98 machines equipped with a dedicated holder. This places the U9000 Plus ultrafilter in the pre-dialyzer flow-path to filter the fluid before it reaches the dialyzer.

U9000 Plus Ultrafilter is intended to be used as a required component of the AK 98 Hemodialysis System, to minimize the risk of exposure to bacteria and endotoxins.

After installation, U9000 Plus Ultrafilter becomes an integral part of the dialysis fluid flow path of the dialysis machine; all machine processes that involve the Ultrafilter (e.g., dialysis fluid preparation, disinfection, rinsing) are controlled by the dialysis machine.

The provided document is a 510(k) premarket notification for a medical device (U9000 Plus Ultrafilter) and does not contain the specific information typically found in a study proving a device meets acceptance criteria for an AI/ML or diagnostic imaging device.

This document describes a water purification system for hemodialysis and its substantial equivalence to a predicate device. The "performance testing" mentioned refers to engineering and chemical tests for water filtration, not diagnostic performance with human readers or AI.

Therefore, I cannot extract the requested information (Acceptance Criteria Table, Sample Size, Expert Ground Truth, MRMC, Standalone Performance, Training Set details) as it is not present in the provided text.

The "discussion of nonclinical tests" section lists typical engineering and material compatibility tests for a water filter:

• Biocompatibility
• Pressure drop
• Retention capacity for Bacteria and Endotoxin
• Ultrafiltration rate
• Dialysis fluid composition
• Filter and membrane integrity
• Chemical evaluation

These tests are to confirm the device's physical and functional performance for water purification, not diagnostic accuracy or AI performance.

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The EON Portable Reverse Osmosis Water Purification System is intended to be used as a dialysis accessory to produce water through reverse osmosis for use with hemodialysis equipment. EON can be connected to hemodialysis equipment used in hospitals, clinics and in home environments, in conjunction with the appropriate pre and post treatment units, as part of a water treatment system designed to meet current AAMI and Federal (U.S.) standards.

EON has optional heat disinfection cycles intended to disinfect the reverse osmosis (RO) machine and product loop, and connection tubing to the hemodialysis machine. EON's heat disinfect the connection tubing (heat forward cycle) is intended to be used only with hemodialysis machines which contain their own heat disinfection cycles and hence are able to tolerate high temperatures. EON is not intended to heat disinfect the hemodialysis machine.

The device is a portable water purification system which uses reverse osmosis to remove contaminants from water that is used to dilute dialysis concentrate to form dialysate for use in hemodialysis equipment. Feed water enters the unit and is directed through a pump into a RO membrane. The pump applies a high hydrostatic pressure that forces water from the concentrated (feed) side to the dilute (product) side of the RO membrane. As water flows across the membrane purified water is produced. Both subject and predicate devices are designed to maintain low microbiological levels in the flow pathway by using optional cycles which perform heat disinfection on the entire RO machine and loop. The subject device also has an optional Heat Forward cycle which is intended to heat disinfect the connection tubing to the hemodialysis machine.

The EON is capable of generating purified water that meets AAMI water quality requirements for hemodialysis. It must be used with appropriate pre and post treatment units, including at a minimum carbon adsorption media pretreatment in order to remove chlorine/chloramines. Additional pre and post treatment requirements may vary and are dependent on the quality of the local feed water supply and individual facility requirements.

The EON system is designed to maintain low microbiological levels in the flow pathway through regular heat disinfection and chemical sanitization. Notable components and features of the EON include:

• RO membrane .
• System pump .
• Water quality monitoring system .
• Operating panel and programmable logic controller (OPLC) .
• Heat disinfection and chemical sanitization capability .
• Audible and visual alarms .
• Automatic divert to drain mode upon start-up and anytime product water . TDS is above the quality set-point
• System control via a touch-screen user interface .
• Heat forward cycle intended to heat disinfect connection tubing from the . Portable Reverse Osmosis Water Purification System to the hemodialysis machine.

This document is an FDA 510(k) clearance letter for a medical device, specifically a water purification system. As such, it describes the device itself and its comparison to predicate devices, but it does not contain detailed information about acceptance criteria or a study proving the device meets those criteria in the context of an Artificial Intelligence/Machine Learning (AI/ML) enabled device.

The provided text focuses on:

• Device Name: EON Portable Reverse Osmosis Water Purification System
• Indication for Use: To produce water through reverse osmosis for use with hemodialysis equipment, and optional heat disinfection cycles.
• Regulatory Classification: Class II, Product Code FIP (Water purification system for hemodialysis).
• Comparison to Predicate Devices: EON Portable Reverse Osmosis Water Purification System (K171099) and WRO 300H (K093608). The key difference is the membrane used and minor component changes.
• Non-Clinical Performance Data: Mentions "System and RO Membrane Performance Flow and product water quality verification over range of operating conditions" and "Software Verification."

Therefore, I cannot provide the requested information about acceptance criteria and a study proving the device meets those criteria as it pertains to an AI/ML device. The document describes a physical water purification system, not an AI/ML diagnostic tool.

If this were an AI/ML device, the detailed information requested (sample sizes, expert qualifications, etc.) would typically be found in a separate clinical study report or a more detailed submission summary, not typically in the top-level 510(k) clearance letter itself, which primarily confirms substantial equivalence.

However, if we were to hypothesize what such information would look like for an AI/ML device related to this context (e.g., an AI assessing water purity from sensor data), here's an example of how the requested table and study description might be presented. This is purely illustrative and not based on the provided document.

Hypothetical AI/ML Device for Water Purity Assessment in Hemodialysis

Let's imagine a hypothetical AI/ML device that analyzes sensor data from the EON Portable Reverse Osmosis Water Purification System to predict water purity levels and flag potential issues (e.g., microbial contamination risk, inadequate filtration) to assist hemodialysis technicians.

1. Table of Acceptance Criteria and Reported Device Performance (Hypothetical)

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The Mar Cor Purification Millenium HX Portable Reverse Osmosis Water Purification System is intended to be used as a dialysis accessory to produce water through reverse osmosis for use with hemodialysis equipment.

The Millenium HX can be connected to hemodialysis equipment used in home environments, in conjunction with the appropriate pre and post treatment units, as a part of a water treatment system designed to meet current AAMI and Federal (U.S) standards.

The device is a portable water purification system that uses reverse osmosis to remove contaminants from water that is used to dilute dialysis concentrate to form dialysate for use in hemodialysis equipment. Feed water enters the unit and is directed through a pump into a RO membrane. The pump applies a high hydrostatic pressure that forces water from the concentrated (feed) side to the dilute (product) side of the RO membrane. As water flow across the membrane all types of water contaminants except dissolved gasses are removed and the purified product water is then supplied to hemodialysis equipment.

The Millenium HX is capable of generating purified water that meets AAMI water quality requirements for hemodialysis at a minimum of 1.4 liters/min. It must be used with appropriate pre and post treatment units, including at a minimum carbon adsorption media pretreatment in order to remove chlorine/chloramines. Additional pre and post treatment requirements may vary and are dependent on the quality of the local feed water supply and individual facility requirements.

The Millenium HX system is designed to maintain low microbiological levels in the flow pathway through regular heat disinfection and chemical sanitization. Notable components and features of the Millenium HX include:

• RO membrane .
• System pump .
• Water quality monitoring system .
• Operating panel and programmable logic controller (OPLC) .
• Heat disinfection and chemical sanitization capability .
• Audible and visual alarms .
• Automatic divert to drain mode upon start-up and anytime product water TDS is above . the quality set-point
• System control via a touch-screen user interface .

Let's analyze the provided document to extract the information required to describe the acceptance criteria and the study proving the device meets those criteria.

Based on the provided text, the device is a medical water purification system, not an AI/ML diagnostic or assistive device. Therefore, many of the typical criteria and study elements associated with AI/ML device approval (such as MRMC studies, ground truth establishment for images, expert adjudication, training/test set sample sizes, and specifics on expert qualifications) are not applicable to this document.

The document describes the Millenium HX Portable Reverse Osmosis Water Purification System, which is a water purification system for hemodialysis. The FDA's review focuses on its substantial equivalence to predicate devices based on its function, intended use, technology, and performance data related to water quality.

Here's how we can address the request based on the provided text:

Description of Acceptance Criteria and Study for Millenium HX Portable Reverse Osmosis Water Purification System

The Millenium HX Portable Reverse Osmosis Water Purification System is intended to produce purified water for hemodialysis equipment. The FDA cleared this device based on its substantial equivalence to previously cleared predicate devices (Millenium HX Portable Reverse Osmosis Water Purification System, 510(k) K110578 and WRO 300H, 510(k) K093608). The acceptance criteria primarily revolve around the device's ability to consistently produce water meeting the specified quality standards for hemodialysis, demonstrated through non-clinical performance testing.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a water purification system, the "performance" is about water quality parameters, flow rates, and functional consistency. The document refers to meeting AAMI (Association for the Advancement of Medical Instrumentation) and Federal (U.S.) standards for water quality for hemodialysis. Specific numerical acceptance criteria for all parameters are not explicitly detailed in the provided summary but are implied by adherence to these standards.

Note: Specific numerical limits for contaminants (e.g., maximum allowable levels of ions, endotoxins, bacteria) that are part of AAMI and Federal standards are not provided in this summary but would be the detailed acceptance criteria for such a device.

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

• Sample Size for Test Set: The document describes "non-clinical performance data" including "System and RO Membrane Performance - Flow and product water quality verification over range of operating conditions" and "Software Verification." It does not specify a "sample size" in terms of patient data or a number of independent test cases in the way an AI/ML model would use them. Instead, it refers to testing of the physical system under various conditions. The sample size would relate to the number of tests performed on the physical system (e.g., number of runs, duration of tests, various inlet water conditions). This information is not detailed in the provided summaries.
• Data Provenance: This refers to laboratory/bench testing of the device itself rather than patient data. The testing was conducted by Cantel (Mar Cor Purification, Inc.). The document does not specify the country of origin for the raw input water used in testing, but it's presumed to be part of the manufacturer's internal testing process. The study is inherently prospective in the sense that new testing was conducted specifically for this submission to verify performance metrics.

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

• Not Applicable: For a physical water purification device, "ground truth" is established by objective measurements using calibrated laboratory equipment to determine water quality parameters (e.g., conductivity meters for TDS, chemical assays for specific ions, microbiological cultures for bacterial counts). It doesn't involve human experts interpreting data to establish a "ground truth" for a diagnostic label. The "experts" involved would be those performing and analyzing the physical and chemical tests, presumably qualified laboratory technicians and engineers, but their number and specific qualifications are not detailed here.

4. Adjudication Method for the Test Set

• Not Applicable: There is no interpretation or classification that would require adjudication. Performance is measured against predefined objective physical and chemical standards (AAMI and Federal regulations).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No: An MRMC study is relevant for diagnostic or assistive AI technologies where human reader performance is being evaluated with and without AI assistance. This device is a water purification system, not a diagnostic tool.

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

• Not Applicable (in the AI/ML sense): The device (Millenium HX) is the "standalone" entity here in that its performance as a water purification system is evaluated directly. There is no separate "algorithm" to be evaluated independently of the device's function. The device's "performance" characteristics (flow, water quality, safety features) are tested and verified.

7. The Type of Ground Truth Used

• Objective Measurement/Reference Standards: The ground truth for the performance of this device is established by physical, chemical, and microbiological measurements of the purified water, compared against pre-defined regulatory and industry standards (AAMI and Federal [U.S.] standards) for water quality suitable for hemodialysis. This would involve laboratory testing to confirm levels of contaminants, conductivity, flow rates, and microbiological purity.

8. The Sample Size for the Training Set

• Not Applicable: This is not an AI/ML device that requires a "training set" of data to learn from. Its operation is based on physical principles (reverse osmosis) and engineered design.

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

• Not Applicable: Since there is no training set for an AI/ML model, this question is not relevant. The "development" and "validation" of such a device are based on engineering principles, materials science, and testing against known physical and chemical standards.

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