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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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The AquaBplus Water Purification Systems are reverse osmosis units 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. These devices are intended to be a component in a complete water purification system, and are not complete water treatment systems. Each 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 AquaBplus is a microcontrolled, fully automatic reverse osmosis which uses pretreated soft water for the production of highly deionized water for use by hemodialysis devices and for the preparation of dialysis concentrates.

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 disinfection. If there is a need, the quality of the permeate could be raised by using the AquaBplus B2 as a second reverse osmosis (2nd membrane filtration step). The AquaBplus B2 is a module that will be installed after the AquaBplus (=main reverse osmosis).

To allow an automatic heat disinfection of the permeate ring main, the module AquaBplus HF could be installed afterwards the AquaBplus/AquaB2. The heat disinfection could take place in dialysis free times.

The produced dialysis permeate will be transferred to the permeate ring main by pressure, where it will be distributed to the different withdrawal units of the dialysis machines. Alternatively permeate could be transferred into a permeate storage tank system. A permeate distribution system (pump, filter, tubing) follows normally to a permeate storage system. In most cases, the feed line into the permeate storage tank is realized as a ring main. Because the most installation type is the ring main and to ease the following description, the components following the AquaBplus system is simply called "ring main".

The provided text is a 510(k) Summary for the AquaBplus Water Purification System. This document focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, rather than conducting a detailed clinical study with acceptance criteria in the typical sense of a medical diagnostic or AI device.

Therefore, many of the requested categories for describing acceptance criteria and study details cannot be directly extracted or are not applicable. I will provide information based on what is available in the text.

Acceptance Criteria and Reported Device Performance

Explanation: The "acceptance criteria" here are primarily regulatory and performance standards that the device must meet to demonstrate safety and effectiveness for its intended use and to establish substantial equivalence to predicate devices. The "reported device performance" indicates that the AquaBplus system passed all these tests and standards.

Study Details (Based on available information)

1. Sample size used for the test set and the data provenance: Not applicable. This was a series of non-clinical performance tests (software validation, chemical and microbiological testing, biocompatibility testing, electrical and electromagnetic safety testing, usability testing, and performance testing against device specifications) performed on the device itself, not on a dataset of patient information.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for this type of device is compliance with engineering, safety, and performance standards, established through recognized testing methodologies and standards, rather than expert interpretation of patient data.
3. Adjudication method for the test set: Not applicable. This type of device verification does not involve adjudication of expert opinions. Rather, it involves objective measurements against established standards.
4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI/diagnostic device that would involve human readers or an MRMC study.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device itself is a standalone water purification system. Its performance was evaluated in isolation regarding its ability to meet specified standards.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" was compliance with established international and national standards for medical devices and water purification systems for hemodialysis (e.g., ISO 13959, ISO 23500, IEC 60601-1, ISO 10993).
7. The sample size for the training set: Not applicable. This is not a machine learning or AI device that would involve a training set.
8. How the ground truth for the training set was established: Not applicable.

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