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The HemoCare Bicarbonate Concentrate Set (BCS) is indicated for use in the preparation of dialysate in a 3-stream proportioning hemodialysis machine with a compatible mechanical interface, such as the HemoCare Hemodialysis System. The BCS is intended for extracorporeal bicarbonate hemodialysis for chronic renal failure, according to a physician's prescription.

The HemoCare Bicarbonate Concentrate Set (BCS) is the Subject Device of this submission. It consists of powdered sodium bicarbonate in a single use cartridge with an integrated tubing assembly for interfacing with hemodialysis systems with compatible three-stream proportioning connector ports such as the HemoCare Hemodialysis System. The HemoCare System uses the bicarbonate concentrate in 3-stream, 45x proportioning to generate dialysate for bicarbonate hemodialysis therapy.

This document is a 510(k) summary for the HemoCare Bicarbonate Concentrate Set (BCS). It outlines the device, its intended use, comparison to a predicate device, and performance data. However, it does not describe a study involving an AI/Machine Learning (ML) device.

Therefore, I cannot provide information on acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details as they pertain to an AI/ML device.

The document focuses on the HemoCare Bicarbonate Concentrate Set, which is a medical accessory for hemodialysis, and its performance data relates to biocompatibility and bench testing to verify specified performance, not the performance of an AI/ML algorithm.

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