(57 days)
The EKGenius Smart System is intended to acquire a resting, diagnostic 12-lead ECG for display and subsequent upload to EKGenius Smart System software, which is installed on an iPad or iPhone. This enables clinicians, or trained care personnel who are acting on the orders of a licensed physician, to acquire, store, and print diagnostic 12lead ECGs.
The EKGenius Smart System is for use on adult and pediations, diseased or non-diseased and is not intended for use on neonatal (birth to 28 days) or infants (29 days up to 2 years). The device is not for use as a vital signs physiological monitor.
The EKGenius Smart System is intended to be used for clinical use rather than home used in a professional healthcare facility, or a clinical environment such as clinics. It cannot be used in transport environment, such as ambulance.
The EKGenius Smart System provides uninterpreted 12-lead ECG data and is not to be a sole means of diagnosis.
Not Found
The provided text is a 510(k) clearance letter from the FDA for the EKGenius Smart System, an electrocardiograph. While it outlines the device's indications for use and regulatory compliance, it does not contain any information about the acceptance criteria or the study that proves the device meets those criteria.
The letter primarily focuses on the substantial equivalence determination, general controls, and regulatory requirements that apply to the device. Details regarding performance studies, test sets, ground truth establishment, or expert involvement are not typically included in these clearance letters.
Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and study details based on the provided text.
§ 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).