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The MAC-Line CO2 Nasal Cannula sample line is used whenever the physician wants to monitor the breathing in a non intubated patient. The intended use of the MAC-Line CO₂ 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 a gas sampling nasal cannula. The gas sampling nasal cannula is used with a capnograph (carbon dioxide analyzer 21CFR 868.1400). There is a Nasal Sampling Cannula at one end of the device for connecting to the patient's nose and a Female or Male Luer Lock on the other end for connecting to the Capnograph. The design and construction of the Microstream Nasal Cannula is identical to the Microstream Nasal Cannula Filterline (K980325) except for the modification of removing the in line hydrophobic 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 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.

This submission (K012391) for the MAC-Line CO2 Nasal Cannula sample line does not describe a study involving acceptance criteria or device performance as would typically be found for novel technologies or those requiring extensive clinical validation. Instead, this 510(k) summary is for a relatively simple medical device that is found to be "Substantially Equivalent" to already legally marketed predicate devices.

The core of this submission revolves around establishing substantial equivalence by demonstrating that the modified device (MAC-Line CO2 Nasal Cannula sample line) is identical in design and construction to a previously cleared device (Oridion Microstream Nasal Cannula Filterline K980325), with the only modification being the removal of an in-line hydrophobic filter.

Therefore, many of the requested elements for a detailed study description are not applicable in this context.

Here's a breakdown based on the provided document:

1. A table of acceptance criteria and the reported device performance

• Not Applicable. The document explicitly states: "The intended use of the modified device, as described in its labeling, has not changed as a result of the modification." And "...The design and construction of the Microstream Nasal Cannula is identical to the Microstream Nasal Cannula Filterline (K980325) except for the modification of removing the in line hydrophobic filter."
• Since the device is virtually identical to a cleared predicate (except for a filter removal) and its intended use remains unchanged, no new performance criteria or testing for device performance are reported. The assumption is that the performance characteristics, already established for the predicate device, remain valid.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Applicable. No new test set or data provenance is mentioned as this is a substantial equivalence claim based on design similarity, not new performance data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable. Ground truth establishment is not relevant for this type of submission which relies on design comparison rather than clinical performance evaluation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable. No test set or adjudication method is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not Applicable. This is a simple medical device, not an AI-powered diagnostic tool. Thus, MRMC studies or AI involvement are completely irrelevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not Applicable. This is a hardware device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not Applicable. No "ground truth" as typically understood in performance studies is used for this substantial equivalence submission. The "ground truth" for the clearance is essentially the established safety and efficacy of the predicate device.

8. The sample size for the training set

• Not Applicable. There is no training set for this type of device submission.

9. How the ground truth for the training set was established

• Not Applicable. There is no training set or ground truth establishment for a training set described.

In summary:

This 510(k) submission for the MAC-Line CO2 Nasal Cannula sample line is a prime example of demonstrating substantial equivalence for a relatively low-risk device (Class II) where the primary argument is that the device is so similar to an already cleared predicate that new performance studies are not required. The "study" here is essentially a detailed comparison of the new device's specifications to those of its predicate, showing that the only difference (removal of an in-line filter) does not alter the fundamental safety or effectiveness for its intended use.

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