(232 days)
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.
The proposed device can acquire ECG signal via twelve leads simultaneously, display or print waveform of ECG signal. The ECG electrical signals from patient body surface are acquired by disposable ECG electrodes; after been amplified, filtered and transferred, the ECG signal waveforms are displayed on the LCD and recorded on the paper via an external printer.
The provided text is a 510(k) Summary for a Digital Electrocardiograph. It contains information about the device's substantial equivalence to a predicate device, focusing on non-clinical tests and technical specifications. However, it does not include any details about clinical studies, acceptance criteria for an algorithm's performance, or the specific information requested about human reader performance, ground truth establishment for a test set or training set, or sample sizes related to clinical efficacy evaluation.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance: This information is not present. The document focuses on compliance with electrical safety and performance standards for the hardware, not the diagnostic performance of an interpretive algorithm against specific clinical benchmarks.
- Sample sized used for the test set and the data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, type of ground truth, training set sample size, and ground truth establishment for the training set: None of this information is available in the provided text, as it describes a non-clinical assessment for substantial equivalence, primarily focusing on hardware characteristics and safety standards.
The document mentions "automated analysis" and "interpretive statements offered to clinician on an advisory basis only," but it does not provide any data or studies related to the performance or validation of this interpretive function from a clinical accuracy perspective. It primarily verifies that the proposed device met design specifications and complied with relevant safety standards (IEC 60601-1, IEC 60601-2-25, IEC 60601-1-2) which are non-clinical requirements.
§ 870.2340 Electrocardiograph.
(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).