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510(k) Data Aggregation
(297 days)
The eWave monitor is an ambulatory ECG monitor intended to provide continuous extended duration cardiac monitoring. It is indicated for use on patients who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, lightheadedness, pre-syncope, fatigue, or anxiety.
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This document is an FDA 510(k) clearance letter for the eWave Monitor. While it describes the intended use and regulatory classification, it does not contain the detailed information required to fill out the table and answer all the questions about acceptance criteria and the study that proves the device meets them.
The information typically found in a 510(k) summary or a more detailed submission document, which is not provided here, would be needed to answer your specific questions.
Therefore, I cannot extract the requested information from the provided text.
However, based on the type of device (ambulatory ECG monitor), I can provide examples of what might be expected for such a device in a regulatory submission:
1. A table of acceptance criteria and the reported device performance
| Performance Metric | Acceptance Criteria (Example) | Reported Device Performance (Example) |
|---|---|---|
| Arrhythmia Detection Accuracy | ||
| - Sensitivity for AFib | ≥ 90% | 92.5% |
| - Specificity for AFib | ≥ 80% | 85.1% |
| - Sensitivity for Tachycardia | ≥ 90% | 91.0% |
| - Specificity for Tachycardia | ≥ 80% | 83.2% |
| - Sensitivity for Bradycardia | ≥ 90% | 90.5% |
| - Specificity for Bradycardia | ≥ 80% | 82.9% |
| Signal Quality | Percentage of analyzable data > 95% | 97.2% analyzable data |
| Wear Time | Mean wear time > 10 days | 12.3 days (average continuous wear) |
| False positive rate for critical arrhythmias |
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