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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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