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The intended use of the MAC-Line Oz/CO2 Nasal Cannula sample line is to conduct a sample of the adult/pediatric subject's breathing from the subject, via a nasal cannula, to a gas measurement device (capnograph) while simultaneously administering supplemental oxygen projected near the nose and mouth for inhalation.

The MAC-Line O2/CO2 Nasal Cannula sample line device is used whenever the physician needs to measure the CO2 in an adult or pediatric non intubated subject's breathing via a nasal cannula while simultaneously administering supplemental oxygen near the nose and mouth for inhalation.

The common product name for this device is Nasal Cannula Gas sampling line for capnograph with integrated Oxygen Administration means for simultaneously administering supplemental oxygen projected near the nose and mouth for inhalation. The complete device is a combined device consisting of two devices, as described below, integrated to simultaneously perform the function of both devices.

The CO2 gas sampling nasal cannula is used with a capnograph (carbon dioxide analyzer 21CFR 868.1400). There is a nasal cannula at one end of the device for connecting to the patient's nose, a Microstream sample tube with a Male or Female Luer lock on the other end for connecting to the capnograph. The CO2 Cannula is identical to the Oridion CO2 Nasal Cannula K980325.

Attached and integrated with the CO2 nasal cannula is another device for simultaneously administering supplemental oxygen projected near the nose and mouth for inhalation. The O₂ cannula has a tube with a standard O₂ connector bushing on the end for connecting to a normal O2 supply. The O2 device is classified as class I according to 21CFR868.5340.

The provided document is a 510(k) summary for a medical device (MAC-Line O2/CO2 Nasal Cannula sample line) and outlines its intended use, device description, predicate devices, and biocompatibility testing. It does not contain information regarding an AI model, acceptance criteria for an AI model, or a study proving an AI device meets acceptance criteria.

Therefore, I cannot fulfill your request for the following information as it is not present in the provided text:

1. A table of acceptance criteria and the reported device performance (for an AI model)
2. Sample size used for the test set and the data provenance (for an AI model)
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (for an AI model)
4. Adjudication method (for an AI model test set)
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
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used (for an AI model)
8. The sample size for the training set (for an AI model)
9. How the ground truth for the training set was established (for an AI model)

The document focuses on the regulatory clearance of a physical medical device (a nasal cannula with integrated oxygen and CO2 sampling) based on substantial equivalence to predicate devices and biocompatibility testing. There is no mention of an AI component or any studies related to AI model performance.

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