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Digital Electrocardiographs, ECG-3020 / ECG-3030 / ECG-3060 / ECG-6020 / ECG-1220 / ECG-1260 / ECG-1215 / ECG-1216, 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 diagnose heart disease. Digital Electrocardiographs shall be used in healthcare facilities by doctors and/or trained healthcare professionals.

Digital Electrocardiographs, ECG-3020 / ECG-3030 / ECG-3060 / ECG-6020 / ECG-1220 / ECG-1260 / ECG-1215 / ECG-1216, 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 paper through thermal printer. ECG data result and patient information could be stored in the memory of the device.

All the models, ECG-3020 / ECG-3030 / ECG-3060 / ECG-6020 / ECG-1220 / ECG-1260 / ECG-1215 / ECG-1216, of the proposed device, Digital Electrocardiographs, follow the same design principle and similar technical specifications.

The provided text does not contain information about specific acceptance criteria, detailed device performance metrics, or a comprehensive study design proving the device meets acceptance criteria. The document is primarily a 510(k) summary for Digital Electrocardiographs, focusing on their substantial equivalence to a predicate device and adherence to general safety and EMC standards.

Therefore, I cannot populate the table or answer the specific questions about the study design, sample sizes, expert qualifications, or ground truth methods as this information is not present in the provided text.

The text does state:

• "Bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device."
• "The test results demonstrated that the proposed device complies with the following standards: IEC 60601-1: 1988 +A1:1991+A2:1995, Medical Electrical Equipment - Part 1: General requirements for safety. IEC 60601-1-2: 2001 +A1:2004, Medical Electrical Equipment - Part 1: General requirements for safety - Collateral Standard: Electromagnetic compatibility - Requirements and tests"

This indicates that the "acceptance criteria" were the design specifications and compliance with the mentioned IEC standards, and the "study" was "bench tests" to verify these. However, no specific performance metrics or detailed study results are given.

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