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The device is a personal single lead Electrocardiograph monitor. The device is intended for self-testing by patients by recording 15 seconds of the first standard lead I of Electrocardiogram. The recording is activated by the patient when symptoms are experienced or whenever desired as routine recordings to be analyzed by a trained physician. The intended user are Users who are above 20 years old.

The user is normally not required to apply electrode on the body. Two electrodes integrated within the device are provided. The user has to press his thumbs on the two electrodes in order record the ECG signal.

The User may also record ECG signals optionally through auxiliary external electrode provided separately, if thumb pressings are inconvenient for any reason.

The recorded data can be downloaded to Personal Computer via USB interface port. This device is not intended for use as precisely diagnostic tool. This device is also not intended for recording and transmission of user's ECG signal simultaneously. Users with implanted pacemaker are not recommended to use this device.

ReadMyHeart is a handheld, personalized use, dry electrode and affordable ECG recording device that records user's cardiac functions for daily health check. It takes ECG signals of user/patient with thumbs press on electrode at ReadMyHeart gently. The device will record user's ECG signal for 30 seconds, and automatically stores the last 15 seconds signals into the build-in memory, while three parameters measured, mainly, Heart Rate (HR), ST segment and QRS interval of cardiac ECG signal, displays on LCD of the device. User may also record ECG signals optionally through auxiliary external electrode provided separately, if thumb pressings are inconvenient for any reason. The data stored in the memory can be transferred to Personal Computer via USB. With friendly GUI software provided separately, data stored in ReadMyHeart can be printed for analysis, and for long-term tracking. ReadMyHeart is powered by internal battery source. Users may activate the device to acquire ECG Lead I information voluntarily and mutually.

Here's a breakdown of the requested information based on the provided text:

Acceptance Criteria and Device Performance Study for ReadMyHeart

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that the device conforms to applicable PREDICATE device standards and a comparison study was performed. It does not explicitly state quantitative acceptance criteria for the ReadMyHeart device itself, nor does it provide specific numerical performance metrics. Instead, it relies on demonstrating comparability to a predicate device and adherence to general safety and performance standards.

2. Sample Size for the Test Set and Data Provenance:

The document mentions "a comparison study with a hospital use common electrocardiograph recorder was performed," and "recordings performed on the subjects." However, it does not specify the sample size (number of subjects/cases) used for this comparison study.

The data provenance is implied to be clinical, as it states "recordings performed on the subjects" and compares against "a hospital use common electrocardiograph recorder." However, it does not explicitly state the country of origin nor whether it was retrospective or prospective. Given the nature of a comparison study for a new device, it would most likely be prospective data collection.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

The document does not provide any information regarding the number of experts used or their qualifications for establishing ground truth in the comparison study. It only mentions that the recordings should be "analyzed by a trained physician" as part of the intended use, but this is not tied to the specifics of the validation study.

4. Adjudication Method for the Test Set:

The document does not describe any adjudication method used for the comparison study's test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

The document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. The comparison described is for the device's output (ECG recordings) against a standard hospital recorder, not for human readers with and without AI assistance. Therefore, no effect size for human reader improvement with AI is mentioned.

6. Standalone (Algorithm Only) Performance Study:

Yes, a standalone performance study was implicitly done. The "comparison study with a hospital use common electrocardiograph recorder" assesses the performance of the ReadMyHeart device (algorithm + hardware) directly against a benchmark, independent of human interpretation as the primary outcome. The report claims "highly comparable" recordings.

7. Type of Ground Truth Used:

The ground truth used for the comparison study appears to be data obtained from a "hospital use common electrocardiograph recorder." This suggests that the standard hospital ECG served as the reference standard against which the ReadMyHeart's ECG recordings were compared. This could be considered a form of "reference device" or "clinical standard" ground truth.

8. Sample Size for the Training Set:

The document does not mention a training set, nor its sample size. The device is presented as a recording device, not one employing machine learning that typically requires a separate training phase. Its performance is validated through comparison to a standard, rather than through a machine learning model's training and testing regimen.

9. How the Ground Truth for the Training Set Was Established:

Since no training set is mentioned (as the device is not described as a machine learning system), the document does not describe how ground truth for a training set was established.

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