Search Results

The E3-80 device is a 3-channel portable ECG device designed to record up to 24 hours of ECG signal from the chest surface of adult patients in an ambulatory environment.

The device stores ECG data to a removable storage disc for qualified healthcare providers to perform further analysis of recorded ECG.

The E3-80 ECG device is designed to be a portable recorder of electrocardiograms. The device has a storage function in which the recorded signals are automatically stored in a removable storage disc for trained healthcare practitioners to perform further analysis using PC-based software.

The E3-80 ECG device is a light-weight, pocket-size portable recorder of three channel electrocardiograms. The device has adequate battery life and recording capability for continuous recording of the ambulatory ECG signals for up to 24 hours. The recorded signals are automatically stored in a removable Secure Digital (SD) disc for trained healthcare practitioners to perform further analysis using PC-based software.

The provided text focuses on the 510(k) premarket notification for the E3-80 Portable ECG Recorder. It describes the device, its intended use, and its technological characteristics. However, the text does not contain information about specific acceptance criteria for device performance, a study detailing device performance against such criteria, sample sizes for test sets, data provenance, expert involvement for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or training set details.

The document states that "Various bench and user preference tests were performed to ensure that the E3-80 Portable ECG Recorder meets all functional, performance, and stability requirements for its intended use." It also mentions electrical safety, EMC, and biocompatibility testing according to relevant IEC and ISO standards. However, it does not elaborate on the specific performance metrics or the results of these tests in a way that would allow for the creation of the requested table or answer the specific questions about clinical study methodology.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and the reported device performance.
• Sample size used for the test set and the data provenance.
• Number of experts used to establish the ground truth.
• Adjudication method.
• MRMC comparative effectiveness study details.
• Standalone algorithm performance details.
• Type of ground truth used.
• Sample size for the training set.
• How the ground truth for the training set was established.

The provided text primarily focuses on regulatory approval and substantial equivalence to predicate devices, rather than detailed performance and validation study results.

Ask a specific question about this device