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The AVEA is intended to provide continuous respiratory support in an institutional health care environment (e.g. hospitals). It may be used on adult, pediatric, and neonatal patients. It should only be operated by properly trained clinical personnel, under the direction of a physician.

The AVEA is a servo-controlled, software-driven ventilator. It has a dynamic range of breathing gas delivery that provides for neonatal through adult patients. Its graphical user interface module (UIM) has a flat panel color LCD with real time charting and digital monitoring capabilities, a touch screen for interaction, membrane keys and a dial for changing settings and operating parameters. It also has an internal gas delivery system with servo controlled active inhalation and exhalation functions. Using internal batteries this provides inter-hospital transport as well as back up capability due to loss of AC power. The AVEA may be configured as a conventional ventilator or non-invasive positive pressure ventilator (NPPV). It has been designed to function using commonly available accessories.

The provided text does not contain the information requested for acceptance criteria and the study that proves the device meets the acceptance criteria.

The document is a 510(k) premarket notification summary for modifications to the AVEA Ventilator, specifically the addition of a capnometry monitor and onboard barometric pressure sensor. While it mentions "Performance testing verified that the AVEA Ventilator meets it's performance requirements," it does not provide any specific criteria, reported performance values, or details about the studies conducted.

Therefore, I cannot populate the table or answer the specific questions about sample size, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth details, or training set information.

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