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The AirLife™ Nasal Continuous Positive Airway Pressure (nCPAP) System Driver is intended to provide CPAP for use in hospitals to treat newborns and infants with RDS or are recovering from RDS.

The AirLife™ nCPAP System Driver (hardware) delivers a mixture of air and oxygen to provide the prescribed level of CPAP through a circuit and generator. Either a prong or mask is attached to the generator as a patient interface. The generator is held to the infant's nose by a fixation device.

The provided text is a 510(k) summary for the AirLife™ Nasal Continuous Positive Airway Pressure (nCPAP) System Driver. This document describes a medical device and its regulatory submission, not a study that proves a device meets acceptance criteria.

Therefore, I cannot extract the requested information as the document does not contain:

• A table of acceptance criteria and reported device performance.
• Details on sample size, data provenance, ground truth establishment for test or training sets, expert qualifications, or adjudication methods.
• Information on multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.

The document states that "All materials used in the fabrication of the AirLife™ Infant Nasal Continuous Positive Airway Pressure (nCPAP) Driver were evaluated through biological qualification safety tests as outlined in ISO 10993 Part-1 'Biological Evaluation of Medical Devices'. These materials also were tested in accordance with industry recognized test methods and were found to be acceptable for the intended use." This is a general statement about material testing and safety compliance, not a detailed study report with specific acceptance criteria and performance data for the device's functional aspects.

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