(126 days)
The device is intended for home use by users who might have transient symptoms that may suggest cardiac conduction abnormity or by users who want to monitor the cardiac function for HOME HEALTH CARE from Lead I ECG signal. ECG acquisition and transmission is voluntary and mutually activated by the user. The intended users are adults above 20 years old. This device is not intended for use as precisely diagnostic tool. This device is also not intended for recording and transmission of user's ECG signal simultaneously. This device provides a parameter of heart rate variability (HRV) in RR interval which is only mathematical analysis and is not intended to produce any interpretation of those measurements or any kind of diagnosis. The device detects the appearance of irregular heart beat (IHB) during measurement, and gives a warning signal with the reading once the irregular heartbeat is detected. Users with implanted pacemaker are not recommended to use this device.
ReadMyHeart is a handheld, personalized use, dry electrode and affordable ECG recording device that records user's cardiac functions for daily health check. It takes ECG signals of users with thumbs press on electrode at ReadMyHeart gently. The device will record user's ECG signal for 30 seconds, and automatically stores the last 15 seconds signals into the build-in memory, while three parameters measured, mainly, Heart Rate (HR), ST segment and QRS interval of cardiac ECG signal, displays on LCD of the device. The device also detects the appearance of irregular heart beat (IHB) during measurement, and gives a warning signal with the reading once the irregular heartbeat is detected. This device provides a parameter of heart rate variability (HRV) in RR interval which is only mathematical analysis when recording the signal for 180 seconds. The HRV is not intended to produce any interpretation of those measurements or any kind of diagnosis. User may also record ECG signals optionally through auxiliary external electrode provided separately, if thumb pressings are inconvenient for any reason. The data stored in the memory can be transferred to Personal Computer via USB. With friendly GUI software provided separately, data stored in ReadMyHeart can be printed for analysis, and for long-term tracking. ReadMyHeart is powered by internal battery source. Users may activate the device to acquire ECG Lead I information voluntarily and mutually. Furthermore, ReadMyHeart (Model RMH3.0) is modified and has generally the same design from DailyCare BioMedical Inc.'s prior device – ReadMyHeart (RMH2.0, K042814).
Here's a breakdown of the acceptance criteria and the study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states that the ECG parameters algorithm and hardware design in this device (ReadMyHeart RMH 3.0) are exactly the same as in the predicate device (ReadMyHeart RMH2.0, K042814), thus no clinical validation for ECG parameters was required for the RMH 3.0.
Therefore, the acceptance criteria and performance reported mainly pertain to the irregular heartbeat (IHB) detection function.
| Metric / Feature | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| ECG Parameters Accuracy | Substantial equivalence to predicate device (RMH2.0) | Algorithms and hardware are "exactly the same" as RMH2.0. |
| Irregular Heartbeat (IHB) Detection Performance | Meets requirements based on comparison study. | Performance tested with MIT-IBH database and simulators, and "meets the requirements." |
| Heart Rate Variability (HRV) Analysis Accuracy | (Not applicable for clinical validation/diagnosis) | Mathematical analysis only, "not intended to produce any interpretation... or diagnosis." |
| Safety & EMC Conformance | Conforms to IEC 60601-2-25, IEC 60601-1, IEC 60601-1-2. | Device conforms to stated applicable standards. |
| Performance Conformance | Conforms to IEC 60601-2-47 and IEC 60601-2-51 (voluntarily). | Device conforms to stated applicable standards. |
| Environment Tests | Complies with safety requirements. | Tested to comply with safety requirements. |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated, but the "MIT-IBH database" was used. The exact number of recordings or patients from this database used for testing is not specified.
- Data Provenance: The "MIT-IBH database" (likely referring to the MIT-BIH Arrhythmia Database) is a publicly available database of physiological recordings. It contains recordings from various medical centers in Boston and other locations. It is a retrospective dataset.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not explicitly stated for the irregular heartbeat detection study. However, the MIT-BIH Arrhythmia Database is well-annotated by experts in cardiology, often physicians and technicians specialized in ECG interpretation.
4. Adjudication method for the test set:
- Not explicitly stated, but for the MIT-BIH Arrhythmia Database, the ground truth annotations were established through an expert review process, typically involving multiple cardiologists or highly trained technicians converging on a consensus.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done.
- The study described is a comparison of the device's IHB detection function against a database and simulators, not a study involving human readers with and without AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone performance evaluation was done for the irregular heartbeat detection function. The device's algorithm was tested against the MIT-IBH database and simulators.
7. The type of ground truth used:
- For the irregular heartbeat detection, the ground truth was derived from the expert annotations/consensus within the "MIT-IBH database" (likely the MIT-BIH Arrhythmia Database), which is based on expert cardiological interpretation of ECGs.
8. The sample size for the training set:
- Not explicitly stated. Given that the ECG parameters algorithm is "exactly the same" as the predicate device (RMH2.0), the training would have occurred for that prior version. For the IHB detection, if the algorithm was trained on the MIT-IBH database, the training split size separate from the test set is not specified.
9. How the ground truth for the training set was established:
- Not explicitly stated. Assuming the IHB algorithm was developed or refined using data from the MIT-BIH Arrhythmia Database, the ground truth for the training set would also have been established through expert annotations/consensus on ECG waveforms within that database.
§ 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).