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CitriSol acid concentrate dry powder or liquid is indicated for use in the acute and chronic Hemodialysis. It is an accessory to be used with the appropriate Hemodialysis machine in a 3 stream mix in the exact prescribed proportion with ANSI/AAMI/ISO standard water for hemodialysis and Sodium Bicarbonate Mix.

CitriSol is manufactured following strict cGMP's and in accordance with the AAMI/ANSI/ISO 13958:2009 concentrates for hemodialysis and AAMI/ISCHANSI 13959:2009 Water for Hemodialysis. Our product codes are easy to understand. The electrolytes present in each solution. Preceded by CS representing the Citric Acid part. In the 45x proportioning formulations the first three numbers -100 stand for the Na. followed by K (ex 2). Ca (25). -Mg (75). This example stands for CS 100225-75 a 2K 2.5 Ca product. CitriSol acid concentrate comes in liquid and dry powder form. The product is available in all 3 different proportioning, as shown in the table below: 45X LIQUID, 36.83X LIQUID, 35X LIQUID, POWDER. CitriSol, contains all the same electrolytes as Diasol Concentrate and 2.4mEq of Citric Acid. CitriSol, when mixed with ANSI/AAMI/ISO standard water for hemodialysis, has the same chemical equivalence as the predicates.

While the provided text mentions "Citrisol acid concentrates" and its intended use in hemodialysis, it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or MRMC studies.

This document is a 510(k) summary for a medical device called "CitriSol acid concentrate." It primarily focuses on demonstrating substantial equivalence to predicate devices, outlining the product's formulations, and stating its indications for use.

Therefore, I cannot fulfill your request for information regarding acceptance criteria and the study proving the device meets them based on the provided text. The document does not describe such a study or its results.

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