(154 days)
Electrocardiographs, ECG-1101G(1), ECG-1103G(1), ECG-1103LW(1), ECG-1106L, ECG-1112 and ECG-1112D, are intended to acquire ECG signals from adult patients through body surface ECG electrodes. It could complete the ECG measurements of QRS detection. Heart Rate, ventricular ectopic beat (VEB), supraventricular ectopic beat (SVEB) and ST Segment Deviation. ECG with measurements is offered to clinician on an advisory basis only. Digital Electrocardiographs shall be used in healthcare facilities by doctors and/or trained healthcare professionals.
Carewell Digital Electrocardiographs, ECG-1101G(I) / ECG-1103G(I)/ ECG-1103LW(I) / ECG-1106L /ECG-1112 / ECG-1112D, are designed to acquire, analyze, display and record ECG signals from patient body surface by ECG electrodes. After been amplified, fittered and analyzed, the ECG signal waveforms and analysis results are displayed on the LCD and recorded on the paper through thermal printer. ECG data, result and patient information could be stored in the memory of the device.
All the models, ECG-1101G(1) / ECG-1103G(1) ECG-1103LW(1) / ECG-1106L /ECG-1112 / ECG-1112D of the proposed device, Carewell Digital Electrocardiographs, have difference in appearance. but follow the same design principle and similar technical specifications:
They consist of three modules, which are power module and control module, and they have three operation modes, including AUTO Mode (automatic mode), MAN Mode (manual mode) and ANA Mode (analysis mode).
They are standard twelve leads, including bipolar limb leads, augmented unipolar limb leads and unipolar chest leads. And they are using the same accessories.
Here's a breakdown of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document references adherence to several standards but does not explicitly state quantitative acceptance criteria or detailed performance results in terms of accuracy or specific metrics for QRS detection, Heart Rate, VEB, SVEB, or ST Segment Deviation. The statement "Bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device" is a general claim rather than a detailed performance report.
However, the "Intended Use Statement" lists the capabilities that the device is designed to perform, which implies expected performance for these metrics. Based on the mention of ANSI/AAMI EC57:2003, Testing and Reporting performance results of cardiac rhythm and ST-segment measurement algorithms, it can be inferred that the device was tested against the performance requirements outlined in this standard. Without direct access to the full test report or the specific criteria within EC57 for this submission, we can only list the intended functionalities as the implied performance areas.
| Metric/Functionality | Acceptance Criteria (Implied by Standards/Intended Use) | Reported Device Performance |
|---|---|---|
| QRS Detection | Meets requirements of ANSI/AAMI EC57:2003 | Assumed to meet; deemed SE to predicate |
| Heart Rate | Meets requirements of ANSI/AAMI EC57:2003 | Assumed to meet; deemed SE to predicate |
| Ventricular Ectopic Beat (VEB) | Meets requirements of ANSI/AAMI EC57:2003 | Assumed to meet; deemed SE to predicate |
| Supraventricular Ectopic Beat (SVEB) | Meets requirements of ANSI/AAMI EC57:2003 | Assumed to meet; deemed SE to predicate |
| ST Segment Deviation | Meets requirements of ANSI/AAMI EC57:2003 | Assumed to meet; deemed SE to predicate |
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not specify the sample size for the test set or the data provenance (e.g., country of origin, retrospective or prospective) for the performance evaluation of the ECG measurement algorithms (QRS, HR, VEB, SVEB, ST Segment). It only mentions "Bench tests were conducted to verify that the proposed device met all design specifications."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not provide any information regarding the number of experts used, their qualifications, or how ground truth was established for the test set.
4. Adjudication Method for the Test Set
The document does not specify an adjudication method for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study was not mentioned or performed according to the provided text. The submission focuses on device equivalence and performance against standards, not on human reader improvement with AI assistance.
6. Standalone Performance Study
Yes, a standalone study was indicated. The document states, "Bench tests were conducted to verify that the proposed device met all design specifications." The purpose of these tests was to demonstrate that the device's algorithms (for QRS detection, Heart Rate, VEB, SVEB, and ST Segment Deviation) performed according to established standards (specifically referencing ANSI/AAMI EC57:2003), enabling the device to be considered "Substantially Equivalent" to a predicate device. This implies testing of the algorithm's performance independent of human-in-the-loop interaction.
7. Type of Ground Truth Used
The document does not explicitly state the type of ground truth used for the performance evaluation of the algorithms. However, given the reference to ANSI/AAMI EC57:2003, Testing and Reporting performance results of cardiac rhythm and ST-segment measurement algorithms, it is highly probable that a standard, meticulously annotated ECG database (potentially with expert consensus annotations or derived from clinical events) would have been used to establish the ground truth for evaluating the algorithm's performance against the specified metrics.
8. Sample Size for the Training Set
The document does not provide any information regarding the sample size for the training set.
9. How the Ground Truth for the Training Set Was Established
The document does not provide any information on how the ground truth for the training set was established, as no details about a training set are mentioned.
§ 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).