(294 days)
CheckMyHeart Plus is intended to record, recall, store and transfer Lead I ECG signals for home health care use. The intended users are adults above 21 years old. This device is not intended to substitute for a hospital diagnostic ECG device. This device is also not intended for recording and transmission of user's ECG signals simultaneously.
CheckMyHeart Plus is intended to record, recall, store and transfer single lead electrocardiographic monitor for recording and displaying real-time ECG data for home health care use. The intended users are adults above 21 years old who might experience transient symptoms that may suggest cardiac conduction abnormity or by adult users whenever they want to have routine checks. This device is not intended to substitute for a hospital diagnostic ECG device. ECG acquisition and transmission can be voluntarily and mutually activated by the adult users for the purpose of healthcare management and reference for healthcare professionals. 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. CheckMyHeart Plus 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 CheckMyHeart Plus gently. The device will record user's ECG signal for 300 seconds, and automatically stores signals into the build-in memory.
This document describes the CheckMyHeart Plus device and its substantial equivalence to the predicate device, READMYHEART (RMH3.0), as part of a 510(k) submission (K172778). The key focus is on demonstrating that the new device meets the same safety and performance standards as the predicate.
Acceptance Criteria and Reported Device Performance
The acceptance criteria for CheckMyHeart Plus are based on meeting the same safety and performance standards as its predicate device, READMYHEART, and demonstrating that any differences do not raise new concerns regarding safety and efficacy. The reported performance of CheckMyHeart Plus is consistently "Pass" for all tested criteria, matching the predicate device.
Here's a table summarizing the performance characteristics where both devices were tested against IEC60601-2-25:2011:
| No. | Name of Test | Standard | CheckMyHeart Plus (CMH 4.0) | READMYHEART (RMH3.0) |
|---|---|---|---|---|
| 1 | Indication of inoperable ELECTROCARDIOGRAPH | IEC60601-2-25:2011 | Pass | Pass |
| 2 | Goldberger and Wilson LEADS | IEC60601-2-25:2011 | Pass | Pass |
| 3 | Input impedance | IEC60601-2-25:2011 | Pass | Pass |
| 4 | COMMON MODE REJECTION | IEC60601-2-25:2011 | Pass | Pass |
| 5 | Overload tolerance | IEC60601-2-25:2011 | Pass | Pass |
| 6 | Baseline (Noise Level) | IEC60601-2-25:2011 | Pass | Pass |
| 7 | Frequency response (HF)-A | IEC60601-2-25:2011 | Pass | Pass |
| 8 | Low frequency (impulse) response | IEC60601-2-25:2011 | Pass | Pass |
| 9 | Linearity and dynamic range | IEC60601-2-25:2011 | Pass | Pass |
| 10 | Recording Speed | IEC60601-2-25:2011 | Pass | Pass |
Additionally, both devices passed the following safety tests:
| No | Name of Test | Standard | CheckMyHeart Plus (CMH 4.0) | READMYHEART (RMH3.0) |
|---|---|---|---|---|
| 1 | Radiated Emission Measurement | EN55011 :2009+A1:2010 Class B | Pass | Pass |
| 2 | Electrostatic Discharge Immunity Test (ESD) | EN61000-4-2 :2009 EN60601-1-2 :2015 | Pass | Pass |
| 3 | Radiated Susceptibility Measurement (RS) | EN61000-4-3 :2006+A2:2010 EN60601-1-2:2015 | Pass | Pass |
| 4 | Power Frequency Magnetic Field (Magnetic) | EN61000-4-8:2010 EN60601-1-2:2015 | Pass | Pass |
| 5 | Biocompatible evaluation | ISO 10993-1:2009/AC:2010 | Pass | Pass |
Study Details
The provided document describes a "substantial equivalence determination" based on a comparison between the new device (CheckMyHeart Plus) and a legally marketed predicate device (READMYHEART, Model RMH3.0, K050620). The study does not involve clinical trials with human subjects to evaluate diagnostic performance in a clinical setting. Instead, it relies on demonstrating that the new device's technical specifications and test results meet recognized industry standards and are comparable to those of the predicate.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not specify a "test set" in terms of patient data for evaluating diagnostic performance. The tests conducted are primarily engineering and hardware/software verification, typically performed on the device itself or in laboratory settings. There is no mention of patient data or its provenance for these performance and safety tests. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable. The study is not evaluating diagnostic accuracy against a ground truth established by medical experts. It's a technical and regulatory comparison against standards and a predicate device. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. There is no 'test set' requiring adjudication by experts for diagnostic performance. -
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 MRMC study was mentioned or conducted. The device (CheckMyHeart Plus) is for recording, recall, storage, and transfer of Lead I ECG signals for home health care use. It provides a parameter of heart rate variability (HRV) but is explicitly not intended to produce any interpretation of those measurements or any kind of diagnosis. Therefore, it does not involve AI for interpretation or human readers needing assistance. -
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
A standalone performance evaluation was done in the sense that the device's technical specifications and functionalities were tested as an independent unit against engineering standards. However, it's crucial to reiterate that this device is for recording and displaying ECG data, not for automated diagnosis or interpretation. The document explicitly states it "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 type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the safety and performance tests listed (e.g., input impedance, COMMON MODE REJECTION, frequency response), the "ground truth" is defined by the technical specifications and limits set forth in the referenced international standards (e.g., IEC60601-2-25:2011). The tests verify if the device's measured parameters fall within these predefined acceptable ranges. -
The sample size for the training set:
Not applicable. The document does not describe the development of an artificial intelligence (AI) algorithm that would require a 'training set' of medical data. The device's functionality is based on established electrocardiograph principles and hardware/software engineering. -
How the ground truth for the training set was established:
Not applicable, as no training set for an AI algorithm is mentioned or implied.
§ 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).