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The Arion Dialysis Water System is for use in multi-patient hemodialysis. The system consists of pretreatment, reverse osmosis, post-treatment and distribution equipment. The sizing of the system is consisting with the demand of water needed for patients. The water produced will meet the minimum requirements of ANSI/AAMI American National Standard for Water Treatment Equipment for Hemodialysis Applications (RD52:2004 and RD62:2006/A1:2009) and the CMS End Stage Renal Disease (ESRD) Program Interpretive Guidance (based on 42 CFR 494) when used as directed. RO and Pretreatment design is based off of feed water quality to meet the stated specifications. This system is intended to be used in hospitals, dialysis centers, and dialysis clinics.

The Arion Dialysis Water System is comprised of water purification equipment used to purify water for hemodialysis.

The Arion Dialysis Water System (K112331) is a high-purity water system used for hemodialysis. The device's performance relies on its ability to produce water that meets specific quality standards.

1. Acceptance Criteria and Reported Device Performance:

2. Sample Size for Test Set and Data Provenance:

The document does not specify a distinct "test set" in the context of typical clinical or algorithm performance studies. Instead, the device's performance is verified through a series of non-clinical tests conducted at installation and on an ongoing basis. Each installed system acts as its own "test subject."

• Sample Size: Each individual Arion Dialysis Water System installed.
• Data Provenance: Prospective (at the time of installation and quarterly thereafter) as the device is put into use. The country of origin for the data is not explicitly stated, but the applicant (Arion Water, Inc.) is based in Massachusetts, USA, suggesting the testing would primarily occur in facilities within the USA.

3. Number of Experts and Qualifications:

The document does not mention the use of external experts to establish ground truth for this type of device. The ground truth for water quality is established by objective, verifiable laboratory tests against recognized industry standards (ANSI/AAMI).

4. Adjudication Method:

Not applicable. The performance is assessed based on objective water quality measurements and equipment functionality against defined standards, not subjective interpretations requiring adjudication.

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

Not applicable. This device is a water purification system, not an imaging or diagnostic algorithm that would typically involve human readers.

6. Standalone Performance:

Yes, the performance data presented is for the standalone performance of the Arion Dialysis Water System. The device's ability to produce water meeting the required standards is assessed independently.

7. Type of Ground Truth Used:

The ground truth used is based on objective measurements and verifiable compliance with established industry standards and regulations. Specifically:

• Chemical Contaminant Levels: Measured and compared against the maximum acceptable levels specified in ANSI/AAMI RD52:2004 and RD62:2006/A1:2009.
• System Design and Functionality: Compliance with ANSI/AAMI equipment and design regulations, and verification of safe mechanical and electrical operations.

8. Sample Size for the Training Set:

Not applicable. This device is a physical water purification system, not a software algorithm that undergoes a "training" phase with a dataset. Its design and manufacturing are based on engineering principles and compliance with established standards.

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

Not applicable, as there is no "training set" in the context of an algorithm. The design and manufacturing processes are guided by the "ground truth" of established engineering principles and the requirements outlined in ANSI/AAMI RD52:2004, RD62:2006/A1:2009, and CMS ESRD Program Interpretive Guidance.

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