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The AquaC UNO H Portable Water Purification System is a 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.

The AquaC UNO H can be connected to hemodialysis equipment used in hospitals, clinics and in home environments. This device is intended to be 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 posttreatment devices as well, to meet current AAMI/ANSI and FDA recognized U.S. standards.

The AquaC UNO H Water Purification System is a microcontrolled, fully automatic reverse osmosis system with heat disinfection function which uses pretreated soft water for the production of highly deionized water, also called permeate.

The intended use of the reverse osmosis device is to remove organic and inorganic ions and microbiological contaminants from the feed water to fulfill the requirements of ISO 13959 'water for haemodialysis and related therapies'.

The feed water must be of drinking water standard, filtered, free of iron, softened and free of chlorine. Potentially critical limits must be monitored by regular checks.

Bacterial growth in the system must be prevented by continuous operation of the system with a minimum of idle times and by preventive measures such as chemical or heat disinfection.

The device consists of a water inlet section where the inflowing volume of water is volumetrically measured. The water is stored in a break tank and is used by the pump to generate high pressure. The pump generates the high pressure and transports the water to the membrane.

The permeate flows from the membrane through the conductivity cell to the permeate outlet into the ring main. The ring main can be connected directly to a dialysis machine.

The concentrate is discarded via the drain valve to the drain.

The provided text describes the AquaC UNO H Water Purification System, a device intended for hemodialysis, and its premarket notification to the FDA. While it states that performance tests demonstrate compliance with various standards and that the device meets specifications, it does not provide detailed acceptance criteria or the specific results of a study in a manner that would allow for the direct completion of a table detailing "acceptance criteria" and "reported device performance."

Instead, it broadly states that:

• "The results of all these tests show that all specifications and requirements have been met."
• "The AquaC UNO H Water Purification System is capable to meet relevant standards and specifications for the use in haemodialysis and related therapies."
• "The information and performance data provided indicates that the AquaC UNO H is safe and effective and performs at least as well as the predicate devices when used in accordance to the instruction of use."

Given the information provided, it's impossible to create a table with specific numerical acceptance criteria and reported performance values. The document focuses on declaring that the device meets standards and specifications rather than detailing what those specific thresholds and measured outputs were.

Therefore, I cannot fulfill all parts of your request directly from the given text.

However, I can extract information related to the studies performed and other contextual details:

1. Table of Acceptance Criteria and Reported Device Performance:

• Cannot be fully generated. The document states that performance testing was conducted "according to the specifications of the device" and that "all specifications and requirements have been met." However, it does not list these specific specifications or the measured performance values.

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

• Sample Size: Not specified. The document mentions "non-clinical tests" and "Performance testing" but does not provide a sample size (e.g., number of units tested, duration of tests).
• Data Provenance: The tests were performed by "internal and external testing laboratories." Given the manufacturer is based in Germany (Vivonic GmbH, Sailauf, Germany), it is highly probable that the data provenance is Germany or other European countries where these laboratories are located. The document does not specify whether the data was retrospective or prospective.

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

• Not applicable / Not specified. This type of information (experts, ground truth, qualifications) is typically associated with clinical studies involving human interpretation or pathology, not with performance testing of a water purification system's technical specifications (like chemical, microbiological, electrical safety, or usability performance).

4. Adjudication method for the test set:

• Not applicable / Not specified. Adjudication methods like 2+1 or 3+1 are used in clinical trials, particularly for expert review of medical images or outcomes where there might be disagreement. This is not reported for the technical performance testing of 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:

• Not applicable. MRMC studies and "human readers with/without AI assistance" are relevant to AI/imaging diagnostics, not to a water purification system.

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

• Not applicable. This relates to AI algorithms, not a physical water purification system. However, the software validation (according to IEC 62304) implies that the device's control algorithms were tested in a standalone manner. The document does not provide details on the performance outcomes of this specific testing.

7. The type of ground truth used:

• Measurement against established standards and specifications. For chemical and microbiological testing, the ground truth would be the thresholds defined in ISO 13959 and ISO 23500. For electrical safety, it would be IEC 60601-1. For performance testing, it would be "the specifications of the device." These are objective, measurable standards, not expert consensus or pathology in the typical sense.

8. The sample size for the training set:

• Not applicable. The device is a physical water purification system; it does not involve machine learning or AI models that require training sets in the customary sense.

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

• Not applicable. See point 8.

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