(105 days)
The intended use of the Mercury module with Capnostat 5 is to provide: spirometric, and carbon dioxide monitoring in neonatal, pediatric and adult patients during general anesthesia and in the intensive care unit (ICU) and the emergency department (ED). Separate combination CO2/flow sensors are provided for adult, pediatric and neonatal use.
The Mercury module with Capnostat 5 is intended for non-invasive monitoring of the inspired and expired airflow and airway pressure of intention norminds for monthsive non emergency room (ER) patients, as well as capnography in all of these clinical settings. It is intended to serve the same purposes as the flow and carbon dioxide monitoring component of the NICO monitor. The Mercury module with Capnostat 5 is the flow and carbon dioxide monitoring component of the presently 510(k) cleared NICO with MARS monitor. It has been designed to include all of the functionality of the flow and carbon dioxide monitoring components of NCO with CO massurament workilling for a with Capnostat 5 is intended to provide all of the existing flow and CO2 measurement capabilities of the NICO Model 7300 of continuous monitoring of respiratory flow and pressure, and CO2 during anesthesia and intensive care and in the emergency department. The flow sensors connect to a patient airway circuit and provide physiological information to the Mercury module. The parameters directly measured and computed by the module (when connected to a Capnostal 5 sensor) include airway flow and pressure, volume, and CO2. The monitor calculates flow by measuring the pressure drop across a known resistance placed in the breathing circuit. CO2 is measured as the absorption of a known intensity of infrared light by CO2 molecules in the airway.
The provided document does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary for the Mercury Module with Capnostat 5 CO2 Sensor, primarily focusing on its substantial equivalence to a predicate device and its intended use. It does not detail specific performance studies, acceptance criteria, or the methodology for proving these criteria.
Therefore, I cannot populate the requested table or answer the specific questions about sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details based on the provided text.
§ 868.1850 Monitoring spirometer.
(a)
Identification. A monitoring spirometer is a device used to measure continuously a patient's tidal volume (volume of gas inhaled by the patient during each respiration cycle) or minute volume (the tidal volume multiplied by the rate of respiration for 1 minute) for the evaluation of the patient's ventilatory status.(b)
Classification. Class II (performance standards).