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The device is a handheld, personal electrocardiograph (ECG) unit, which can measure electrical activities of the heart easily and conveniently. It's a single LEAD ECG measuring device for home health care use, which can detect, display and store ECG signal, and if possible, provide average heart rate message after ECG measurement. The users can use it themselves to check their heart condition.

It is suitable for the adult users (age 18 or older), who suffers from cardio-vascular diseases, or the adult people who are caring about their heart working conditions during their daily life. This device is not intended for use as a conventional diagnostic tool, but use as a healthcare tool which can provide doctor the recorded data as references. This Device is also not intended for recording and transmission of user's ECG signal simultaneously, and it's not recommended to use with implanted pacemaker.

PC-80 / Prince 180 Easy ECG Monitor is a handheld electrocardiograph unit which can measure, display, and store ECG data by the user. The device can calculate the average heart rate and display the heart rhythm after analysis. Furthermore, it's small, light, and easy to use. A 30-second ECG record is measured and stored in this device. The waveform data and heart rate value can be displayed on LCD screen, and those ECG data records can be reviewed.

Here's a breakdown of the acceptance criteria and study information for the PC-80 /Prince 180 Easy ECG Monitor, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific acceptance criteria (e.g., sensitivity, specificity, accuracy targets) for its performance in detecting or interpreting ECG signals. Instead, the performance testing focuses on compliance with established medical device standards.

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

The document does not provide details on the sample size used for any clinical test set or the data provenance (e.g., country of origin, retrospective/prospective). The performance testing described is primarily focused on engineering and quality system compliance rather than a clinical performance study.

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

The document does not mention any clinical test set involving expert review to establish ground truth for ECG interpretation. The device's intended use is for home health care and as a reference tool for doctors, not as a diagnostic tool itself.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set with human review requiring adjudication is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned. The submission focuses on substantial equivalence based on technical standards and device features, not on improved human reader performance with AI assistance.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) was Done

The testing described is focused on the device as a whole, including its ability to measure, display, and store ECG data, and to provide average heart rate and rhythm information. There's no specific mention of a standalone algorithm performance study in terms of diagnostic accuracy metrics (e.g., sensitivity, specificity) for automatically detecting specific cardiac events. The performance validation is against engineering and safety standards (IEC, AAMI).

7. The Type of Ground Truth Used

For the engineering and safety standards (IEC 60601-1, IEC 60601-1-2, AAMI EC 38) to which the device was validated, the "ground truth" would be the specifications and requirements outlined in those standards. This would involve calibrated test equipment and established protocols to verify electrical safety, EMC, and the accuracy of ECG signal acquisition and basic heart rate calculation as per the AAMI standard. There is no mention of clinical ground truth (e.g., expert consensus, pathology, or outcomes data) in the context of diagnostic accuracy.

8. The Sample Size for the Training Set

The document does not mention a training set, which would typically be associated with AI/ML algorithm development. The device's description suggests a direct measurement and display function, with basic analysis for heart rate and rhythm, rather than a sophisticated AI-driven interpretive algorithm that would require a large training dataset.

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

Not applicable, as no training set is mentioned.

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