(152 days)
The Datex-Engstrom MRI Patient Monitor and accessories is indicated for monitoring of ECG waveform for Heart Rate and Asystole detection, SpO22, Non-invasive blood pressure (NIBP), airway gases, anesthetic agents, airway flow, airway pressure and airway volume on patients during MR imaging. It is indicated for use inside the MRI room mounted outside the 20 Gauss line and with magnets of field strength 1.5 Tesla or less.
SpO2monitoring is indicated only with the use of Datex-Engstrom sensors specifically designed for use in the MRI environment. ECG monitoring is indicated only with use of the MRI ECG lead set.
MRI Patient Monitor and Accessories
I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device (MRI Patient Monitor and Accessories). It does not contain any information about acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement in a study to prove the device meets acceptance criteria.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input.
§ 870.2340 Electrocardiograph.
(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).