(447 days)
The CARDIOVIT AT-102 G2 is a 12-channel ECG unit used for the recording, analysis, viewing, storage and transmission of ECG waveforms. The CARDIOVIT AT-102 G2 is designed for indoor use and can be used for all patient populations. The CARDIOVIT AT-102 G2 is used to diagnose cardiac abnormalities, and detect acute myocardial ischemia and infarctions in chest pain patients. The CARDIOVIT AT-102 G2 is intended for use in hospitals, cardiology units, outpatient clinical units and general physician's offices.
The CARDIOVIT AT-102 G2 is a 12-channel ECG unit used for the recording, analysis, viewing, storage and transmission of ECG waveforms.
The provided text is a 510(k) clearance letter from the FDA for a device called "Cardiovit AT-102 G2." This document primarily covers the FDA's determination of substantial equivalence to a predicate device for marketing purposes.
It does NOT contain information about acceptance criteria, device performance results, sample sizes for testing, expert qualifications for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment for training sets.
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. The document is a regulatory approval letter, not a study report or technical documentation.
§ 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).