(174 days)
CAPNOXYGEN mask is a medium concentration single-use The mask intended to be used for the delivery of supplemental oxygen and monitoring breathing by sampling exhaled carbon dioxide. Standard connectors for the oxygen tubing and a standard female Luer connector for the gas sample line are The mask is intended to be used for monitoring provided. non-intubated patients who are breathing spontaneously.
The Capnoxygen mask provides a means to sample exhaled carbon dioxide via a sample tube inside an oxygen mask, during mouth and/or nose breathing. The gas sample line is connected to the Capnograph monitor by a standard female Luer connector.
The Capnoxygen Mask is designed to deliver supplemental oxygen and monitor breathing by sampling exhaled carbon dioxide. A clinical test was performed to compare its accuracy in measuring CO2 with a predicate device.
1. Acceptance Criteria and Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Accuracy in measuring CO2 compared to predicate device | The clinical test showed equivalent accuracy in measuring CO2 with 95% confidence when compared to the predicate device. |
| Safety - Absence of adverse effects | Neither the Capnoxygen mask nor the predicate device had any adverse effects during the clinical test. |
2. Sample Size and Data Provenance for the Test Set:
- Sample Size: The document does not specify the exact number of volunteers, only stating "a group of volunteers."
- Data Provenance: The study was a prospective clinical test conducted on volunteers. The country of origin is not explicitly stated, but the submission is from Capnoxygen LLC in Lebanon, Tennessee, USA.
3. Number and Qualifications of Experts for Ground Truth (Test Set):
- The document describes a comparative clinical test between the Capnoxygen mask and a predicate device for CO2 measurement. The "ground truth" here appears to be the measurements obtained by both devices rather than a separate expert interpretation of images or signals. Therefore, it does not explicitly mention the use or qualifications of experts to establish a separate ground truth. The comparison is directly between the two devices' measurements.
4. Adjudication Method (Test Set):
- No adjudication method is described. The comparison was directly between the CO2 measurement accuracy of the Capnoxygen mask and the predicate device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No MRMC comparative effectiveness study was mentioned. The study focused on the direct comparison of device accuracy in CO2 measurement, not on how human readers' performance might improve with AI assistance.
6. Standalone (Algorithm Only) Performance:
- This device is a physical mask for oxygen delivery and CO2 sampling, not an algorithm. Therefore, a standalone (algorithm only) performance study is not applicable and was not performed. The "accuracy" refers to the accuracy of the physical mask's ability to sample CO2 for measurement, likely by a connected capnograph monitor (though the monitor itself is not the subject of this 510(k)).
7. Type of Ground Truth Used:
- The "ground truth" for this study was comparative performance data against a legally marketed predicate device (Jemsdal A-221 Capnographic Mask) in terms of CO2 measurement accuracy and safety (absence of adverse effects).
8. Sample Size for the Training Set:
- The document does not mention a training set. This is a physical medical device, not an AI/machine learning model that would typically require a training set. The clinical test described is a validation study.
9. How Ground Truth for the Training Set Was Established:
- Not applicable, as a training set is not mentioned for this device.
§ 868.1400 Carbon dioxide gas analyzer.
(a)
Identification. A carbon dioxide gas analyzer is a device intended to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory, circulatory, and metabolic status. The device may use techniques such as chemical titration, absorption of infrared radiation, gas chromatography, or mass spectrometry.(b)
Classification. Class II (performance standards).