(392 days)
Digital Electrocardiograph is intended to acquire ECG signals from adult patients through body surface ECG electrodes. The obtained ECG records can help users to analyze and diagnose heart disease. Digital Electrocardiograph shall be used in healthcare facilities by doctors and/or trained healthcare professionals.
Digital Electrocardiograph, ECG-2000, is intended to acquire ECG signals from adult patients through body surface ECG electrodes. The obtained ECG records can help users to analyze and diagnose heart disease.
It consists of the acquisition box, optional accessories, installation CD, and USB dongle. The acquisition box is connected with ECG electrodes, and intends to acquire ECG signals from patient. The acquired ECG signal is filtered and amplified, then transferred to the working station. The acquisition box is powered by the working station via a USB line. The working station is a Personal Computer installed with ECG-2000 Software, it intends to receive the processed ECG signal from the acquisition box, and further display and record the signals. Optional accessories include lead wires, limb electrodes and chest electrodes, and general-purpose printer (with USB interface, support PCL language, such as HP1010, P2035, and P2055d series). The CD contains Digital Electrocardiograph installer and dongle installation program module.
The provided text is a 510(k) summary for a Digital Electrocardiograph (ECG-2000) and primarily focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing and comparison of technical specifications. It does not contain information about acceptance criteria for device performance based on clinical studies, nor does it describe such a study.
Therefore, I cannot provide the requested information regarding acceptance criteria, reported device performance from a clinical study, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or how ground truth was established for a training set.
The document states that non-clinical tests were conducted to verify that the proposed device met all design specifications and complied with relevant IEC and EN standards for electrical safety, EMC, and particular requirements for electrocardiographs. It also mentions "Software Verification Test was performed to verify the software functions against its intended use." However, these are engineering verification tests, not clinical performance studies for diagnostic accuracy.
The closest to "acceptance criteria" presented in the document are the technical specifications compared with predicate devices, such as:
| Item | Acceptance Criteria (from predicate device comparison) | Reported Device Performance (Proposed Device) |
|---|---|---|
| Product Code | DPS | DPS |
| Regulation Number | 21 CFR 870.2340 | 21 CFR 870.2340 |
| Class | Class II | Class II |
| ECG Lead | Standard 12-lead | Standard 12-lead |
| Sampling rate | 1000Hz (at least for one predicate) | 1000Hz |
| Electrical Safety | Comply with IEC 60601-1 | Comply with IEC 60601-1 |
| EMC | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 |
| Input circuit current | ≤0.1 μA (for one predicate) | ≤0.1 μA |
| Noise level |
§ 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).