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The intended use of electrocardiograph is to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The electrocardiograph is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by the electrocardiograph can help users to analyze and diagnose heart disease. However the ECG with measurements and interpretive statements is offered to clinician on an advisory basis only.

Digital Electrocardiograph, iE 3/ iE 6/ iE 12/ iE 12A/ iE 15/ ECG-1210/ ECG-3010/ ECG-6010, are intended to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The electrocardiograph is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by the electrocardiograph can help users to analyze and diagnose heart disease. However the ECG with measurements and interpretive statements is offered to clinician on an advisory basis only.

All the proposed models, iE 3/ iE 6/ iE 12/ iE 12A/ iE 15/ ECG1210/ ECG3010/ ECG6010, follow the same design principle, main components, accessories and software; they acquire ECG electrical signals from patient body surface by ECG electrodes. After been amplified, filtered and transferred, the ECG signal waveforms are displayed on the LCD and recorded on the paper through thermal printer.

They consist of four modules, which are power supply module, signal collection module, amplification module, and control module.

They can acquire ECG signal via twelve leads simultaneously, display or print waveform of ECG signal via three channel, six channel, twelve channel or fifteen channel.

The CardioPro analysis program is the analysis program used in this proposed device.

1. Table of acceptance criteria and the reported device performance

The document does not explicitly state acceptance criteria in a quantitative manner for specific performance metrics like accuracy, sensitivity, or specificity regarding the analysis and diagnosis of heart disease. Instead, the submission focuses on demonstrating substantial equivalence to predicate devices and compliance with international safety and performance standards.

The table below summarizes the technical specifications and standards compliance, which implicitly serve as performance requirements for the device's functionality.

2. Sample size used for the test set and the data provenance

The document does not mention a specific "test set" in the context of clinical performance for the interpretation of ECGs or diagnosis of heart disease. The provided information is focused on non-clinical testing to demonstrate compliance with general safety and performance standards (IEC standards) and an assessment of technical characteristics against predicate devices. Therefore, details like data provenance (country of origin, retrospective/prospective) are not applicable or provided for a clinical test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

As there is no mention of a clinical test set with ground truth related to ECG interpretation or diagnosis in this document, there is no information about the number or qualifications of experts used for establishing ground truth. The device's interpretive statements are explicitly stated to be "on an advisory basis only," suggesting that human experts remain responsible for final diagnosis.

4. Adjudication method for the test set

Not applicable, as no clinical test set for diagnostic performance is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, the document does not indicate that a multi-reader multi-case (MRMC) comparative effectiveness study was performed. The non-clinical tests relate to hardware compliance and functional specifications.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The document does not describe a standalone performance study for the algorithm's diagnostic capabilities. The non-clinical tests performed were to verify that the device met design specifications and complied with safety and performance standards. The "CardioPro analysis program" is mentioned, and its interpretive statements are stated to be for "advisory basis only," indicating it's not intended for standalone diagnosis.

7. The type of ground truth used

Not applicable, as no clinical test set for diagnostic performance is described. The "ground truth" implicitly referred to in the non-clinical tests would be the established benchmarks and requirements defined by the IEC standards for technical performance (e.g., signal-to-noise ratio, frequency response).

8. The sample size for the training set

The document does not provide any information about a "training set" or explicit details on how the "CardioPro analysis program" was developed or trained.

9. How the ground truth for the training set was established

Not applicable, as no information on a training set or its ground truth establishment is provided.

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