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• The device is indicated for use to acquire, analyze, display and print electrocardiograms. (Printing function . available only through an external, optional printer.)
• The device is indicated for use to provide interpretation of the data for consideration by a physician. .
• The device is indicated for use in a clinical setting, by a physician or by trained personnel who are acting on . the orders of a licensed physician. It is not intended as a sole means of diagnosis.
• The interpretations of ECG offered by the device are only significant when used in conjunction with a . physician over-read as well as consideration of all other relevant patient data.
• . The device is indicated for use on adult populations.
• The device is indicated for use on pediatric populations for acquisition, display, and printing of multi-channel . ECGs.
• . The device is not intended to be used as a vital signs physiological monitor.

The proposed ELI 10 will be a multi-channel, portable electrocardiograph utilizing a 4" graphic LCD. The ELI 10 is a 12 lead resting interpretive electrocardiograph. The ELI 10 simultaneously acquires data from all 12 leads. Once the data is acquired, it can be reviewed, and/or stored, and/or printed (using an external, optional printer).

The electrocardiogram (ECG) is a graphic description of the electrical activity of the heart. This activity is recorded from the body surface by a group of electrodes positioned at predefined places to reflect the activity from different perspectives. The cardiac data acquired and provided by the ELI 10 is used by trained medical personnel to assist in the diagnosis of symptomatic patients with various rhythm patterns.

The provided text does not contain information about acceptance criteria, device performance, or any studies conducted to prove the device meets specific criteria. The document is a 510(k) premarket notification for the ELI 10 Electrocardiograph, outlining its description, intended use, indications for use, and a letter from the FDA confirming its substantial equivalence to a predicate device.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them, nor can I provide information on sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment. This information is not present in the provided text.

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