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B. Braun Modified Bicarbonate Dialysate is indicated for hemodialysis use with renal replacement therapy systems that utilize sterile bicarbonate dialysate.

The B. Braun Modified Bicarbonate Dialysate Solutions are a family of sterile, non-pyrogenic, bicarbonate dialysate solutions. The solutions will be provided in flexible two-chamber bags, with bicarbonate solution in one chamber and electrolyte solution in the other chamber. The chambers are separated by a peel seam. The 5,000 mL ready-to-use solution is obtained by pressing on the small chamber of the bag until the peel seam opens, and then rocking the bag back and forth to mix the contents.

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves a device meets specific acceptance criteria.

The document is a 510(k) summary for a medical device (B. Braun Modified Bicarbonate Dialysate) and an FDA clearance letter. It primarily focuses on demonstrating substantial equivalence to a predicate device, rather than presenting performance criteria and study results against them.

Therefore, I cannot provide the requested table and study details.

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