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This device is an adjunct to oxygen therapy with its primary functions being that of a conduit for the delivery of intermittent oxygen upon demand to a patient's lungs and to transmit a patient's breath effort to the oxygen conserver. Oxygen is administered only during the inhalation cycle, conserving oxygen during the exhalation cycle.

Airlife Demand Nasal Cannula

I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets those criteria. The document is a 510(k) clearance letter from the FDA for a medical device called "Airlife Demand Nasal Cannula," indicating that the device has been found substantially equivalent to a legally marketed predicate device.

The letter mentions:

• Trade/Device Name: Airlife Demand Nasal Cannula
• Regulation Number/Name: 21 CFR 868.5905, Oxygen Conserving Devices
• Regulatory Class: II
• Product Code: 73 NFB
• Indications For Use: "This device is an adjunct to oxygen therapy with its primary functions being that of a conduit for the delivery of intermittent oxygen upon demand to a patient's lungs and to transmit a patient's breath effort to the oxygen conserver. Oxygen is administered only during the inhalation cycle, conserving oxygen during the exhalation cycle."

However, the document does not include:

1. A table of acceptance criteria and reported device performance.
2. Details about sample sizes, data provenance, number of experts, qualifications of experts, or adjudication methods for any test set.
3. Information on multi-reader multi-case (MRMC) comparative effectiveness studies.
4. Information on standalone algorithm performance.
5. The type of ground truth used.
6. Sample size for the training set.
7. How ground truth for the training set was established.

This document is a regulatory approval notice, not a detailed technical report or study summary. Therefore, I cannot fulfill your request based on the provided text.

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