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The MEMORYTRACE™ Model 4224 monitor is a patient-operated device designed to record and transmit a patient's ECG for the documentation of thythm and/or rate disturbances. The recorded ECG data can be transmitted over a telephone to a standard ECG receiver. The ECG transmissions are intended as aids in evaluating symptomatic episodes of rate disturbances, postmyocardial infarction follow-ups, anti-arrhythmia therapy, and cases that require ST segment analysis.

The MEMORYTRACE™ Model 4224 monitor is a patient-operated device designed to record and transmit a patient's ECG.

This 510(k) summary does not contain the detailed study information needed to answer your request fully. The document focuses on the FDA's substantial equivalence determination for the MEMORYTRACE™ Model 4224 Ambulatory ECG device and its intended use. It does not include information about specific acceptance criteria for performance metrics or a detailed clinical study demonstrating how those criteria were met.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I elaborate on sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance directly from the provided text.

The document states that the device is "substantially equivalent" to legally marketed predicate devices, implying that its performance is considered comparable to existing devices without necessarily providing a new, comprehensive performance study.

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