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The MAC-Line O₂/CO₂ Oral Nasal Cannula sample line is used whenever the physician needs to collect a sample of the patient's breathing to measure CO2 with a capnograph while simultaneously administering supplemental oxygen near the nose and mouth for inhalation. It can be used for adult, intermediate or pediatric nonintubated patients.

The common product name for this device is Oral Nasal Cannula Gas sampling line The common product hame for the contrastration means for simultaneously for caphograph with integrated Oxygen projected near the nose and mouth for inhalation.

The gas sampling cannula is used with a capnograph (carbon dioxide analyzer The gas sampling cannula is assuming Cannula at one end of the device for 2 TCFN 000. 1400). There is a camping of the mate Luer Lock on the other end for connecting to the capnograph.

A plastic tube joins the two connectors. One end of the tube is connected to the A plastic lube joins the wo connoctore. One on the other end of the tube is source of the pation. The capnograph has a pump that creates a vacuum connected to a odphograph. The satient's breathing (exhalation) through the sampling tube into the capnograph.

The provided text is a 510(k) summary for the MAC-Line O2/CO2 Oral Nasal Cannula sample line. It does not contain information about acceptance criteria, device performance testing, study design, or ground truth establishment.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given information. The document focuses on regulatory clearance by demonstrating substantial equivalence to previously marketed devices, rather than presenting new performance data from a clinical or validation study.

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