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The Pure Water, Inc.'s Bicarb Mix, Storage and Distribution system is intended to be used in the mixing, storage and distribution of Bicarb liquid concentrate to be used in the treatment of Hemodialysis patients.

Pure Water, Inc.'s Bicarb Mix, Storage and Distribution System uses Reverse Osmosis, provides for batch mixing of Bicarb liquid concentrate, transfer to storage and delivery to point of use.
The Bicarb Mix Tank allows Bicarb liquid concentrate to be mixed in batches then transferred to a Storage Tank.
The Storage and Distribution components of the system serve to deliver Bicarb liquid concentrate to the point of use.
Pure Water, Inc.'s Bicarb Mix, Storage and Distribution System can be customized to best meet the needs of the user.
Pure Water, Inc.'s Bicarb Mix, Storage and Distribution System meets or exceeds all Association for the Advancement of Medial Instrumentation (AAMI) National Standards for Hemodialysis.

This document describes a medical device called "Pure Water, Inc.'s Bicarb Mix, Storage and Distribution System" which is intended for hemodialysis patients. It is a physical system for mixing, storing, and distributing bicarbonate liquid concentrate. The information provided in the K993272 submission is a summary for regulatory approval, not a performance study report for a diagnostic AI/ML device. Therefore, the requested information regarding acceptance criteria, study details, expert consensus, and training/test set specifics for an AI/ML device is not applicable to this document.

The submission states that the device "meets or exceeds all Association for the Advancement of Medial Instrumentation (AAMI) National Standards for Hemodialysis," which serves as its acceptance criterion for safety and efficacy in its intended use. However, it does not provide specific performance metrics or a study in the format typically associated with AI/ML device validation.

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