(134 days)
The InstantCheck RTD-ECG monitor is a personal single lead electrocardiographic monitor for recording and displaying real-time ECG data for home health care use. This device is intended for self-testing by adult users who might experience transient symptoms that may suggest cardiac conduction abnormity or by adult users whenever they want to have routine checks.
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.
The user is normally not required to apply electrode on body. Two electrodes integrated within the device are provided. The user has to press his/her thumbs on the electrodes in order to record the ECG signal. The users may also record the signals optionally through auxiliary external electrode provided separately if thumb pressing is not convenient for reason. The recorded data can be downloaded to Personal Computer via USB interface port.
The InstantCheck RTD-ECG monitor is a new model of handheld ECG monitors series of DailyCare BioMedical Inc. InstantCheck RTD-ECG is a handheld, personalized use, dry electrode and affordable ECG recording device that records user's cardiac functions and displays the data in a clear and precise waveform for daily health check. It takes ECG signals of users by thumbs pressing gently on electrodes which are integrated on the device. InstantCheck RTD-ECG can record real-time display the user's ECG data for about 30 seconds, and automatically store the last 15 seconds signals into the build-in memory. While three parameters were measured, mainly, Heart Rate (HR), ST segment and QRS interval of cardiac ECG signal, will be displayed on LCD display of the device.
User may also record ECG data 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 InstantCheck RTD-ECG can be printed for analysis, and for long-term tracking. InstantCheck RTD-ECG is powered by internal battery source. Users may activate the device to acquire ECG Lead I information voluntarily and mutually.
InstantCheck RTD-ECG is not intended for use as a substitution of precise diagnostic tool. This device is also not intended for recording and transmission of user's ECG signal simultaneously. Users with implanted pacemaker are not recommended to use this device.
This document is a 510(k) Premarket Notification for the InstantCheck RTD-ECG monitor. It focuses on demonstrating substantial equivalence to a predicate device and adherence to relevant safety and performance standards, rather than providing a detailed study proving the device meets specific acceptance criteria based on complex clinical outcomes or AI performance.
Therefore, many of the requested categories regarding clinical studies, AI performance, ground truth, and expert adjudication are not applicable as described for an AI/ML device.
Here's an analysis based on the provided text:
Acceptance Criteria and Device Performance (Non-Clinical)
The document does not explicitly state "acceptance criteria" in terms of clinical accuracy metrics (like sensitivity, specificity, or AUC) as one would expect for an AI/ML diagnostic device with a clinical endpoint. Instead, the "acceptance criteria" are implied by adherence to recognized electrical safety, EMC, and performance standards. The "reported device performance" refers to its compliance with these standards and its functional specifications.
| Acceptance Criteria (Implied by Standards) | Reported Device Performance (Compliance) |
|---|---|
| Electrical Safety (IEC 60601-2-25 & IEC 60601-1) | Conforms to applicable standards |
| EMC Requirements (IEC 60601-1-2) | Conforms to applicable standards |
| Performance Tests (IEC 60601-2-47 and IEC 60601-2-51) | Conforms to applicable standards. The performance is also tested with MIT-IBH database and simulators. Measures Heart Rate (HR), ST segment, and QRS interval. |
| Environment Tests | Complies with safety requirements |
Study Details (Based on the provided document)
-
Sample size used for the test set and the data provenance:
- The document mentions "MIT-IBH database and simulators" for performance tests. The specific sample size (number of ECGs or patients) from the MIT-IBH database used for testing is not specified.
- Data Provenance: The MIT-IBH database is a publicly available database from MIT, often used for algorithm development and testing in cardiology. The geographical origin of the patients in the database is not specified in this document. The data is retrospective as it's a pre-existing database.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as described for an AI/ML diagnostic device. The MIT-IBH database contains expert-annotated ECGs, but this document does not detail how the ground truth for this specific study was established (e.g., number of cardiologists for review). It assumes the inherent ground truth of the database.
-
Adjudication method for the test set:
- Not applicable as described for an AI/ML diagnostic device. The document does not describe a process of expert adjudication for this specific device's performance against a test set.
-
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, an MRMC comparative effectiveness study was not conducted or reported in this document. This device is a monitor, and the premarket notification focuses on its functionality and safety, not on improving human reader performance with AI assistance. It states the monitor is for "healthcare management and reference for healthcare professionals" but is "not intended for use as a substitution of precise diagnostic tool."
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, in a way. The performance tests against the MIT-IBH database and simulators represent a standalone evaluation of the device's ability to measure ECG parameters (HR, ST segment, QRS interval) against established references, which is an "algorithm only" type of test for the device's signal processing capabilities.
-
The type of ground truth used:
- Expert Consensus/Reference Standards: For the MIT-IBH database tests, the ground truth is derived from the established and validated annotations within that database, which are typically based on expert cardiologists' interpretations and reference recordings. For the functional parameters (HR, ST, QRS), the ground truth would be the known, reference values in the database or from simulators.
-
The sample size for the training set:
- Not specified. The document states that the InstantCheck RTD-ECG monitor has "the same fundamental scientific technology as the original cleared device, ReadMyHeart." It doesn't describe an AI model that would typically have a separate training set. The underlying technology (signal processing to derive HR, ST, QRS) would be developed and validated rather than "trained" on a dataset in the modern AI sense.
-
How the ground truth for the training set was established:
- Not applicable. As no distinct "training set" for an AI algorithm is described, the method for establishing its ground truth is not relevant here. The device's core functionality relies on established signal processing principles for ECG analysis.
§ 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).