Clinical Evaluation Criteria for Automatic Diagnosis of 12-lead Electrocardiograph / 中国医疗器械杂志

ABSTRACT

The automatic diagnosis function of the electrocardiograph (ECG) machine directly affects the clinical application of the device. However, there is currently no unified criteria for the evaluation of the automatic diagnosis function of the 12-lead ECG machine in clinic. We established a 12-lead ECG automatic diagnostic function clinical evaluation specification from the scope of the specification, the automatic diagnostic function judgment rules, general technical measurement requirements, test methods and conditions, and ECG data input. Emphasis is given to the judgment rules of the automatic diagnosis function, including the accuracy of ECG feature values, the interpretation and judgment of automatic diagnosis results. This specification aims to provide technical basis for the clinical evaluation for automatic diagnosis function of the 12-lead ECG.