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Digital Electrocardiographs, ECG-8080/ iE 3S/ iE 12/ iE 12P, are intended to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The obtained ECG records can help users to analyze and disease. Digital Electrocardiographs shall be used in healthcare facilities by doctors and/or trained healthcare professionals.

Digital Electrocardiographs, ECG-8080/ IE 3S/ iE 12/ iE 12P, are designed to acquire, display and record ECG signals from patient body surface by ECG electrodes. After been amplified and filtered, the ECG signals waveforms are displayed in the LCD and recorded in the paperthrough thermal printer. ECG data result and patient information could be stored in the memory of the device.

All the models, ECG-8080/ iE 3S/ iE 12/ iE 12P, of the proposed device, Digital Electrocardiographs, follow the same design principle and similar technical specifications.

The provided document is a 510(k) summary for Digital Electrocardiographs. It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study with detailed performance metrics. Therefore, it does not contain the information requested in your prompt regarding acceptance criteria, study details, sample sizes for test and training sets, expert qualifications, or ground truth establishment methods.

The document indicates "Bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device." However, it does not provide specific performance criteria or results from these bench tests beyond compliance with general safety and EMC standards (IEC 60601-1, IEC 60601-2-25, IEC 60601-1-2).

Therefore, I cannot populate the table or answer the specific questions about the study that proves the device meets acceptance criteria based on the provided text.

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