(35 days)
The QT ECG System is intended to acquire, record and process an electrocardiographic signal so that it can be transmitted digitally via Bluetooth technology to a cell-phone or mobile device, then to a remote location. The QT ECG System is indicated for use on infants, children and adults. It is designed to be operated by adults in the home, or by healthcare workers in non-acute care clinical facilities (such as nursing homes, skilled nursing facilities), and in professional healthcare facilities (such as clinics, hospitals, and ambulances) to record and transmit a 12- lead ECG and rhythm strip in near real-time to enable review at a physician's office, hospital or other medical receiving centers.
The QT ECG system is a non-defibrillator-proof, hand-held, cordless 12-lead electrocardiograph (ECG) system with Bluetooth connectivity. The QT ECG system consists of 5 maior components:
- The QT ECG Recorder-Compact device that records 12-lead, resting electrocardiograms, then transmits the recorded data to a mobile device (smartphone, tablet, etc.) paired via Bluetooth. A Bluetooth-enabled mobile device (not included) is needed to operate the QT ECG Recorder, and to send the recorded rhythm strip to a cardiologist or licensed physician for review.
- The QT ECG Electrode Strip-Disposable, patented electrodes that are prepositioned on a self-adhesive strip.
- The QT ECG App - Software that lets the user uses their mobile device to operate the QT ECG recorder, then send the recorded data via cloud to a certified medical professional for review.
- Analysis The analysis module provides ECG measurement from the collected data. It does not make any interpretation of the intervals provided based on factors such as heart rate, QRS duration, etc.
- Web Service - The web service provides an interface for communication. The recorded ECG data is saved temporarily on the mobile device until it is transferred via the Internet to the cloud server. The QT ECG System does not have monitoring capabilities and does not have diagnostic alarm function. The QT ECG System is indicated for use on infants, children and adults. It is designed to be operated by adults in the home, or by healthcare workers in non-acute care clinical facilities (such as nursing homes, skilled nursing facilities), and in professional healthcare facilities (such as clinics, hospitals, and ambulances) to record and transmit a 12- lead ECG and rhythm strip in near real-time to enable review at a physician's office, hospital or other medical receiving centers.
The provided text describes the QT ECG (QTERD100) device and its submission for FDA clearance. The submission, K233521, is a Special 510(k) comparing the device to a previously cleared version (K220795). The changes primarily relate to an expanded indication for use to include Emergency Medical Services (EMS) environments and updated environmental operating conditions and supported mobile devices.
Here's an analysis of the acceptance criteria and study data based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document presents a comparison between the subject device (K233521) and the original device (K220795), focusing on the differences. The "Acceptance Criteria" column explicitly states the criteria for the tests conducted to validate these differences.
| Device Change | Acceptance Criteria | Summary of Results |
|---|---|---|
| Indications for Use (addition of EMS) | Pass the test according to IEC 60601-1-12. | Pass. The risk is controlled. The document: Risk Management Plan, Risk Control Report, Risk Management Summary, Report of IEC 60601-1-12 |
| Storage and transport temperature | (Implicit: device functions within new temperature range) | (No explicit "Pass" for this row, but overall "Pass" for the change) |
| Operating Temperature | (Implicit: device functions within new temperature range) | (No explicit "Pass" for this row, but overall "Pass" for the change) |
| Storage and Transport Atmospheric Pressure | (Implicit: device functions within new atmospheric pressure range) | (No explicit "Pass" for this row, but overall "Pass" for the change) |
| Operating Atmospheric Pressure | (Implicit: device functions within new atmospheric pressure range) | (No explicit "Pass" for this row, but overall "Pass" for the change) |
| Ingress Protection Rating (IP33 vs IP22) | (Implicit: device meets new IP33 rating) | (No explicit "Pass" for this row, but the "Summary of Results" column isn't provided for this specific change. However, the overall conclusion states all safety and performance tests were passed.) |
| Package | N/A (change in packaging format, no performance impact expected) | N/A |
| Quick guide | N/A (simplification for risk reduction, no performance impact expected) | N/A |
| Mobile device (updated supported models/OS) | Pass criteria according to test reports: Unit Test, Integration Test, System Test | Pass. The risk is controlled. The document: Risk_Management_Plan, Risk_Control_Report, Risk_Management_Summary, Software Test reports: Unit Test, Integration Test, System Test |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify sample sizes for any of the tests mentioned (e.g., IEC 60601-1-12, software tests).
The data provenance is also not explicitly stated in terms of country of origin or whether it was retrospective or prospective. The document mentions tests being conducted "according to IEC 60601-1-12," which implies standard compliance testing, but doesn't detail the origin of the test data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide information regarding the use of experts to establish a ground truth for the test set, nor does it mention their number or qualifications. The tests conducted appear to be primarily engineering and safety compliance tests rather than clinical studies requiring expert ground truth for interpretation of ECG data.
4. Adjudication Method for the Test Set
Since there's no mention of experts establishing a ground truth or interpreting data, there's no information about an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. The device is described as acquiring, recording, and transmitting ECG signals for review by a physician, but there's no study presented that evaluates the performance of human readers with or without AI assistance, or an effect size. The "Analysis module" for the device provides ECG measurements but "does not make any interpretation."
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The document describes the device's "Analysis module" which "provides ECG measurement from the collected data. It does not make any interpretation of the intervals provided based on factors such as heart rate, QRS duration, etc." This indicates that the device itself performs some algorithmic processing (measurement) but does not provide diagnostic interpretation. Therefore, a standalone diagnostic performance study (algorithm only) as typically understood for AI-based diagnostic devices, is not described here. The presented studies focus on safety, electrical performance, and software validation.
7. Type of Ground Truth Used
Given the nature of the tests (compliance with standards like IEC 60601-1-12, software validation), the "ground truth" would be defined by the technical specifications of the standards themselves (e.g., passing specific electrical tests, proper software function as per design documents) rather than expert consensus, pathology, or outcomes data related to ECG interpretation. The document does not describe studies requiring such clinical ground truth.
8. Sample Size for the Training Set
The document does not mention a training set sample size. Since the device's "Analysis module" provides measurements but no interpretation, it's unlikely to involve machine learning models that require extensive training data in the traditional sense for diagnostic capabilities. The software validation tests mentioned ("Unit Test, Integration Test, System Test") are for functional correctness rather than training predictive models.
9. How the Ground Truth for the Training Set Was Established
As no training set is described, there is no information on how ground truth for a training set was established.
§ 870.2920 Telephone electrocardiograph transmitter and receiver.
(a)
Identification. A telephone electrocardiograph transmitter and receiver is a device used to condition an electrocardiograph signal so that it can be transmitted via a telephone line to another location. This device also includes a receiver that reconditions the received signal into its original format so that it can be displayed. The device includes devices used to transmit and receive pacemaker signals.(b)
Classification. Class II (performance standards).