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The Oridion MAC-Line Oral Nasal Cannula sample line device is used whenever the breathing in a non intubated patient. The intended use of the Oridion MAC-Line Oral Nasal Cannula sample line is to Conduct a sample of the patient's breathing from the patient to the gas measurement device for measuring the percentage of CO2 in the patient's exhalation. The intended use of the modified device, as described in its labeling, has not changed as a result of the modification.

The common product name for this device is an oral nasal cannula gas sampling line. The gas sampling nasal cannula is used with a capnograph (carbon dioxide analyzer 21CFR 868.1400). There is a sampling cannula at one end of the device for connecting to the patient's nose and mouth and a Male or Female Luer on the other end for connecting to the capnograph. The design and construction of the Oridion MAC-Line Oral Nasal Cannula sample line is identical to the Microstream Nasal Cannula Filterline (K011050) except for the modification which consists of removing the hydrophobic in line filter. The two connectors are joined by a plastic tube. One end of the tube is connected to the source of the patient's exhalation (nose and mouth and the other end of the tube is connected to a capnograph. The capnograph has a pump that creates a vacuum which draws a sample of the patient's breathing (exhalation) through the sampling tube into the capnograph for analysis of the CO₂ content of the patient's exhalation.

The provided text does not contain information about acceptance criteria or a study proving that the device meets those criteria. It is a 510(k) summary for the Oridion MAC-Line Oral Nasal Cannula sample line, describing its intended use, device description, and substantial equivalence to legally marketed predicate devices.

Specifically, the document states:

• Product Name: Oridion MAC-Line Oral Nasal Cannula sample line
• Intended Use: To conduct a sample of the patient's breathing from the patient to the gas measurement device for measuring the percentage of CO2 in the patient's exhalation.
• Device Description: An oral nasal cannula gas sampling line used with a capnograph, identical to the Microstream Nasal Cannula Filterline (K011050) except for the removal of the hydrophobic in-line filter.
• Substantial Equivalence: Declared substantially equivalent to the Microstream Oral Nasal Cannula Filterline (K011050) and Salter Labs Model 4001 Adult, Salter Labs Model 4101 Pediatric (FDA K864199) Oral Nasal Cannulas.

The document is a notification from the FDA confirming that the device is substantially equivalent to a predicate device and can be marketed. It does not detail any performance studies, acceptance criteria, or specific data provenance, sample sizes, expert qualifications, or ground truth establishment relevant to the device's performance against specific metrics. Therefore, it is not possible to fill out the requested table and answer the study-related questions based on this document.

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