(88 days)
The Bernoulli MS software is intended to be used on a central monitoring station on patients using supported devices in a hospital or hospital type environment. It is used to provide a secondary display of ventilator, respiratory monitor, IV infusion (including PCA) pump, feeding pump, and/or multi parameter monitor data (ECG, respiratory rate, pulse oximetry, ETCO2, blood pressure, cardiac output, temperature and associated derived outputs) to the central station, and to provide remote monitoring and alarm surveillance. The Bernoulli MS is intended to supplement and not replace any part of the current device monitoring procedures.
Not Found
This appears to be a 510(k) clearance letter from the FDA for the Bernoulli™ Management System, and not a study describing acceptance criteria and device performance. The letter states that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory information.
Therefore, the requested information about acceptance criteria, device performance, study design, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC/standalone study results is not present in the provided document.
The document specifically states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent...". This indicates a regulatory review based on equivalence to existing devices, not a detailed performance study where specific acceptance criteria and their fulfillment are described.
§ 868.5895 Continuous ventilator.
(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).