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Gambro BiCart® is indicated for use in bicarbonate hemodialysis for acute and chronic renal failure, or acute intoxication with dialyzable substances.

Gambro BiCart® Sodium Bicarbonate for hemodialysis is a dry concentrate used to prepare bicarbonate concentrate solution for use in conventional hemodialysis.

The Gambro BiCart® is a non-refillable cartridge containing sodium bicarbonate, which enables on-line preparation of bicarbonate hemodialysis solution. It is used in conjunction with appropriate acid dialysis concentrate and water meeting Association for the Advancement of Medical Instrumentation (AAMI) guidelines. The resulting dialysate is used in conventional, commercially available hemodialysis machines/monitors which have been adapted to receive the cartridges.

This document is a 510(k) Premarket Notification for the Gambro BiCart® Sodium Bicarbonate for Hemodialysis and does not describe a study, acceptance criteria, or performance data related to an AI/ML device. Therefore, I cannot generate the requested information based on the provided text.

The document explicitly states:

• "No clinical testing was performed."
• "No testing was necessary to determine equivalence to predicate devices."

The Gambro BiCart® is a chemical consumable for hemodialysis, not an AI/ML-driven medical device that would have acceptance criteria in terms of algorithm performance metrics like sensitivity, specificity, or reader improvement. The 510(k) submission focuses on demonstrating substantial equivalence to previously cleared predicate devices based on indications for use, technological characteristics, and chemical composition.

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