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The ABL735 is intended for in vitro testing of samples of whole blood for the parameters pH, pO₂, pCO₂, potassium, sodium, calcium, chloride, glucose, lactate, total bilirubin, and co-oximetry parameters (total hemoglobin, oxygen saturation and the hemoglobin fractions FO₂Hb, FCOHb, FMetHb, FHHb, and FHHbF).

ABL735 is an automated pH/Blood Gas/Co-oximetry/Electrolyte/Metabolite Analyzer that is 44cm X 70cm X 50cm (HWD) and weighs 30kg. It measures on whole blood in approximately 60 seconds.

The provided text is a 510(k) summary for the Radiometer ABL735 analyzer, which details its intended use and establishes substantial equivalence to predicate devices. However, it does not include information about acceptance criteria, efficacy studies, sample sizes, ground truth establishment, or expert involvement. Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets them based on the provided input.

The document is a regulatory submission focused on demonstrating that a new device is "substantially equivalent" to already legally marketed devices. This process often relies on showing similar technological characteristics and intended use, rather than conducting new, extensive efficacy studies with specific acceptance criteria that would be reported in detail in such a summary.

If such studies were performed to establish the device's performance, the details you're asking for would typically be found in a separate study report or a more comprehensive performance evaluation section, which is not present here.

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