(26 days)
The CG-6108 ACT-3L Continuous ECG Monitor and Arrhythmia Detector is intended for use by patients who experience transient symptoms that may suggest cardiac arrhythmia. The device continuously monitors patient ECG, automatically generates an alarm triggered by an arrhythmia detection algorithm, or generates an alarm manually triggered by the patient, and transmits the recorded data transtelephonically to a monitoring center. The monitoring center provides the ECG data to the medical practitioner for evaluation.
CG-6108 ACT-3L Continuous ECG Monitor and Arrhythmia Detector is designed for self-testing by patients at home and for analysis by medical professionals at a remote Monitoring Center.
The chest-worn sensor is used for the acquisition, recording, and transmission of the ECG signal. The device is equipped with 4 electrodes on a harness and it houses a 3.6V AA battery, a Bluetooth transceiver and a buzzer.
The ECG signals are transmitted via Bluetooth to a handheld device with a proprietary interactive application, configured to process and transmit the ECG recordings. The handheld device is a mobile computing device with a display and a touch input such as a cell-phone. It has sufficient memory and processing capability to run the proprietary application.
When an arrhythmia event is detected the handheld device transmits the recorded ECG information automatically via cellular link, to the Monitoring Center or professional analysis. When cellular service is unavailable the patient has an option to transmit via a landline telephone.
The provided text describes the CG-6108 ACT-3L Continuous ECG Monitor and Arrhythmia Detector, but it is a 510(k) Summary, not a detailed study report. Therefore, it does not contain the full details required to answer all aspects of your request comprehensively. Specifically, information regarding specific acceptance criteria values, reported device performance metrics against those criteria, detailed sample sizes for test and training sets, data provenance, expert qualifications, adjudication methods, MRMC study results (effect size), and training set ground truth establishment are largely absent or only broadly mentioned.
However, based on the information available, here's what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance:
The document broadly states that the device was subjected to "extensive verification / validation testing" and "designed to ensure that the device meet all of its functional and performance requirements and is fit for its intended use." It also mentions conformance with the "Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm, October 28, 2003" and ANSI/AAMI/ISO EC57:1998 (R) 2008 for "Testing and Reporting Performance Results of Cardiac Rhythm and ST Segment Measurement Algorithms."
Unfortunately, specific numerical acceptance criteria (e.g., sensitivity, specificity thresholds for arrhythmia detection) and the device's reported performance against these criteria are NOT provided in this summary. The summary only lists general categories of performance validation.
| Acceptance Criteria Category (Implied from guidance) | Reported Device Performance (Summary only) |
|---|---|
| Arrhythmia Detection Algorithm Performance | "Arrhythmia Detection Algorithm Performance Validation" (No specific metrics provided) |
| Software Functional Unit Verification | "Software Functional Unit Verification" (No specific metrics provided) |
| System Level Software Validation | "System Level Software Validation" (No specific metrics provided) |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "Arrhythmia Detection Algorithm Performance Validation" as part of the testing. However, it does not specify the sample size used for this validation or the data provenance (e.g., country of origin, retrospective/prospective nature of the data).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This information is not provided in the 510(k) summary. It only states that the monitoring center provides ECG data to the medical practitioner for evaluation, implying professional review, but it doesn't detail the ground truth establishment for the validation study itself.
4. Adjudication Method for the Test Set:
This information is not provided in the 510(k) summary.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:
The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study evaluating human reader improvement with AI assistance. The focus seems to be on the algorithm's standalone performance and the system's ability to transmit data to a monitoring center for professional analysis.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
Yes, a standalone performance evaluation of the algorithm was done. The document explicitly states: "Arrhythmia Detection Algorithm Performance Validation." This implies that the algorithm's ability to detect cardiac events (Atrial Fibrillation, Tachycardia, and Pause) was validated independently of a human interpreter at the point of detection, although human input at the monitoring center is part of the overall clinical workflow.
7. The Type of Ground Truth Used:
The document does not explicitly state the type of ground truth used for the algorithm validation. Given the nature of ECG monitoring and arrhythmia detection, it is highly probable that the ground truth would typically be established by expert consensus of cardiologists or electrophysiologists reviewing the ECG traces. However, this is an inference, not an explicit statement in the provided text.
8. The Sample Size for the Training Set:
The document does not provide any information regarding the sample size used for the training set of the arrhythmia detection algorithm.
9. How the Ground Truth for the Training Set Was Established:
The document does not provide any information regarding how the ground truth for the training set was established.
In summary, the provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device and outlines the general testing performed to meet regulatory guidance. It does not contain the detailed clinical study results and methodology typically found in a full clinical validation report.
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.