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The Handheld ECG Monitor OTC version is intended to record and store Lead I ECG signals, and display three ECG parameters for home health care use. The intended users are adults above 20 years old. This device is not intended to substitute for a hospital diagnostic ECG device. Users with implanted pacemaker are not recommended to use this device. The Handheld ECG Monitor OTC version has simple user interface without ECG trace viewing function.

Handheld ECG Monitor is a handheld, personalized use and affordable ECC Lead I recording device with metal electrode that records user's cardiac function for daily health check by palm. The device will record user's ECG signal for 30 seconds and display the measured parameters including heart rate, ST segment, and QRS duration. It is not intend for automatic analysis or diagnostic ECG device.

The device can store 200 records. Handheld ECG Monitor is powered by internal battery source. And the device has setting function including date, time, ID number, backlight and Beep sound.

The provided text describes a 510(k) summary for the Handheld ECG Monitor Model MD100A1-F. This document focuses on demonstrating substantial equivalence to a predicate device and includes a non-clinical test conclusion, but it does not contain detailed information about specific acceptance criteria, a study proving those criteria were met, or device performance against such criteria.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I answer questions regarding sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details as this information is not present in the provided text.

The closest information available is the "Non-Clinical Test Conclusion," which states that "Bench tests were conducted to verify that the proposed device met all designs specifications as was demonstrated that the proposed device complies with the following standards." It then lists several IEC and ISO standards related to medical electrical equipment safety, electromagnetic compatibility, and biological evaluation. However, these are general compliance statements and not specific performance acceptance criteria or a study demonstrating direct device performance against those criteria.

In summary, the provided document focuses on regulatory compliance and substantial equivalence to a predicate device, but it lacks the specific performance data and study details requested in your prompt.

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