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This device, consisting of a generator, prongs, masks and a headgear/fixation device is intended to provide continuous positive airway pressure to newborns and infants with compromised respiratory systems while in a hospital environment.

The Cardinal infant nCPAP system consists of a Generator, Prongs, Masks, and a headgear/fixation device. A 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 straps connected to a headgear/fixation device. This product is a single patient use, non-sterile prescriptive device.

This document describes the Airlife Infant Nasal Continuous Positive Airway Pressure (nCPAP) System. It outlines its intended use and claims substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study proving that the device meets those criteria, as typically found in a performance study section.

Therefore, I cannot populate the table or answer the subsequent questions regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment based on the provided text.

The document primarily focuses on:

• Device Description: Consists of a generator, prongs, masks, and a headgear/fixation device, delivering a mixture of air and oxygen to provide prescribed CPAP.
• Intended Use: To provide continuous positive airway pressure to newborns and infants with compromised respiratory systems while in a hospital environment.
• Substantial Equivalence Claim: To the EME Infant Flow System, based on the same intended use and similar performance attributes.
• Summary of Testing: Materials used were evaluated through biological qualification safety tests (ISO 10993 Part-1) and tested according to industry-recognized methods, found acceptable for the intended use.
• Regulatory Information: Class II device (21CFR §868.5905), Product Code: BZD.

In summary, the provided text from the 510(k) summary focuses on establishing substantial equivalence through intended use, device description, and material safety testing. It does not include a performance study with acceptance criteria and reported device performance metrics in the format requested.

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