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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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The BioPure HX2 Reverse Osmosis water purification system is designed to purify pre-treated water using reverse osmosis for making dialysate for hemodialysis applications. The device is intended to be a component in a complete water purification 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. BioPure HX2 is intended for use in water rooms in a hospital, clinic, or dialysis center. The device includes an integrated heat disinfection process.

The BioPure HX2 is available two different double pass configurations that supply 5 gallons per minute (gpm) and 11 gpm. Version HX2P-05 is a double pass triple membrane RO that produces up to 5 gpm of product water. Version HX2P-11 is a double pass six membrane RO that produces up to 11 gpm of product water.

The device is a 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. The key feature of BioPure HX2 RO system is that it consists of two trains (1st and 2nd pass) of membrane elements. Feed water enters the unit and is directed through a pump into the 1st pass 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. The product water is then pumped directly through the 2nd pass membrane elements to further improve water quality of the final product water. 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 BioPure HX2 is capable of generating purified water that meets AAMI water quality requirements for hemodialysis at a minimum of 3 US gallons/minute (11.30 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 BioPure HX2 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 BioPure HX2 include:

• Break Tank
• Immersion Heater
• 1st Pass RO Booster Pump
• 1st Pass RO membrane
• 2nd Pass RO Booster Pump
• 2nd Pass RO membrane
• Particle and Pyrogen Filter (Optional)
• Piping
• Water quality monitoring system
• Programmable logic controller (PLC)
• Heat disinfection and chemical sanitization capability
• Audible and visual alarms
• Automatic divert to drain mode upon start-up and anytime product quality parameters are not met.
• System control via a touch-screen user interface

The BioPure HX2 Reverse Osmosis Water Purification System is intended to purify pre-treated water for use in hemodialysis applications. The device is evaluated primarily against the requirements listed in FDA's Guidance for the Content of Premarket Notifications for Water Purification Components and Systems for Hemodialysis (May 1997) and the FDA recognized consensus standards - ISO 26722:2009 Water treatment equipment for hemodialysis applications and related therapies and ISO 13959:2009 Water for hemodialysis and related therapies.

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not explicitly present a table of acceptance criteria with corresponding performance data in a structured format as requested. Instead, it lists the types of performance data provided to the FDA to support substantial equivalence. Based on the descriptive information, the key performance criterion is the ability to generate purified water meeting AAMI water quality requirements at a minimum flow rate.

2. Sample Size for Test Set and Data Provenance:

The document does not specify the sample sizes used for individual test sets for each type of validation (e.g., System and RO Membrane Performance, Heat Disinfection Process Validation). The data provenance is not explicitly stated as retrospective or prospective, nor does it mention the country of origin of the data. However, as this is a 510(k) submission to the US FDA, the testing would generally be expected to follow US regulatory guidelines and standards.

3. Number of Experts and Qualifications for Ground Truth:

This device is a water purification system, not a diagnostic device requiring expert interpretation of medical images or data. Therefore, the concept of "experts used to establish the ground truth" in the traditional sense of clinical diagnosis is not applicable. The "ground truth" for this device is based on objective chemical and physical measurements to confirm water quality parameters and system performance against established standards (AAMI, ISO). Validation of these measurements would be conducted by qualified engineers and technicians with expertise in water purification systems and relevant analytical techniques.

4. Adjudication Method:

Given that the ground truth is established through objective measurements and validated processes against predefined standards, an adjudication method (such as 2+1 or 3+1 used in medical image interpretation) is not relevant. Performance is determined by direct measurement against quantitative acceptance criteria.

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

An MRMC study is not applicable to a water purification system. MRMC studies are typically used to evaluate the diagnostic performance of medical imaging devices or AI algorithms where human readers interpret medical cases. This device's function is to purify water, not to assist human readers in making diagnoses.

6. Standalone Performance:

Yes, the testing described for the BioPure HX2 involves evaluating its standalone performance as a water purification unit. The listed data types such as "System and RO Membrane Performance", "Heat Disinfection Process Validation", and "Chemical Sanitization Validation" are all assessments of the device's inherent capabilities and performance without human-in-the-loop directly influencing the water purification process itself. While human operators manage the system, the performance metrics relate to the automated and technical functions of the device.

7. Type of Ground Truth Used:

The ground truth used for this device is based on objective measurements and established scientific/engineering standards.

• AAMI Water Quality Requirements: These are standards for the chemical and microbiological purity of water used for hemodialysis.
• ISO 26722:2009 and ISO 13959:2009: These are international standards for water treatment equipment and water quality for hemodialysis.
• FDA Guidance: Provides regulatory expectations for such devices.

The "ground truth" is therefore derived from:

• Analytical Chemistry Results: Measuring levels of contaminants, conductivity, etc.
• Microbiological Testing: Assessing bacterial counts.
• Engineering Specifications and Performance Data: For flow rates, pressure, temperature, etc.
• Validation Protocols: Demonstrating the effectiveness of disinfection and sanitization cycles.

8. Sample Size for the Training Set:

The concept of a "training set" is typically associated with machine learning or AI models. The BioPure HX2 is a physical medical device (water purification system) and not an AI algorithm that undergoes a training phase. Therefore, there is no "training set" in this context. The device's design, engineering, and manufacturing would be based on established principles and validated through the testing mentioned above.

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

As there is no "training set" for this physical device, this question is not applicable.

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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 hospitals, clinics and 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 0.26 US gallons/minute (1.0 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 .

The provided text is a summary of a 510(k) premarket notification for a medical device (Millenium HX Portable Reverse Osmosis Water Purification System). It does not describe a clinical study of the type that would typically involve acceptance criteria, sample sizes for test/training sets, expert adjudication, or MRMC studies for AI devices.

Instead, this document focuses on demonstrating substantial equivalence to existing predicate devices through non-clinical performance data. Here's a breakdown based on the information provided, highlighting why it doesn't align with the requested format for AI device studies:

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

The document doesn't present a table with specific, quantitative acceptance criteria and corresponding reported device performance values in the way one would for an AI algorithm's diagnostic accuracy. However, it does state that the device is "capable of generating purified water that meets AAMI water quality requirements for hemodialysis at a minimum of 0.26 US gallons/minute (1.0 liters/min)." This implies a performance criterion related to water flow and quality.

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 applicable. The device is a water purification system, and its performance is evaluated through engineering tests, not a clinical test set of 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)

This is not applicable. Ground truth for a water purification system is established through laboratory measurements and adherence to engineering standards (like AAMI water quality), not expert consensus on medical images or diagnoses.

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

This is not applicable. Adjudication methods are relevant for subjective assessments, typically in clinical studies, not for the objective performance validation of a mechanical device like a water purification system.

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. An MRMC study is used to evaluate the impact of an AI algorithm on human reader performance, which is not relevant for a water purification device.

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

This is not applicable. The Millenium HX is a physical device, not an AI algorithm.

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

The "ground truth" for this device's performance would be the objective measurements of water quality and flow rates, verified against established standards such as AAMI water quality requirements for hemodialysis and potentially other federal (U.S.) standards.

8. The sample size for the training set

This is not applicable. The concept of a "training set" is relevant for machine learning algorithms, not for a physical water purification system undergoing engineering validation.

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

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

Summary of the Study and Device Performance (based on provided text):

The "study" refers to the non-clinical performance data provided by Mar Cor Purification to the FDA. This data aims to demonstrate that the Millenium HX is safe and effective for its intended use and is substantially equivalent to predicate devices.

Acceptance Criteria (Implied) and Reported Device Performance:

Study Details:

• Type of Study: Non-clinical performance data and validation testing, not a clinical trial involving human subjects or an AI algorithm evaluation.
• Data Provenance: The studies were conducted by the manufacturer, Mar Cor Purification. Country of origin not explicitly stated, but the company address is in Minneapolis, MN, USA. The nature of the tests suggests they are prospective engineering and laboratory validations.
• Ground Truth: Objective measurements against established engineering and water quality standards (e.g., AAMI RD62:2006).

Conclusion from document: Mar Cor Purification concluded that the Millenium HX is safe and effective for its intended use based on the provided information and performance data, and is substantially equivalent to legally marketed predicate devices. The FDA subsequently cleared the device.

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