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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 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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