(291 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 arthythmia. The device continuously monitors patient ECG, automatically generates an alert triggered by an arrhythmia detection algorithm, or generates an alert manually triggered by the patient, and transmits the recorded data trans-telephonically to a monitoring center provides the ECG data to the medical practitioner for evaluation.
The CG-6108 ACT-3L Continuous ECG Monitor and Arrhythmia Detector is intended to be prescribed for patients who have demonstrated a need for cardiac monitoring and are at low risk of developing life-threatening arrhythmias. Conditions where the system should not be used include patients likely to experience primary Ventricular Fibrillation or Ventricular Tachycardia and patients who have other co-morbid cardiovascular conditions where an arrhythmia could be potentially life threatening.
This device has not been tested for and it is not intended for pediatric use.
The 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 patient alert 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 for professional analysis. When cellular service is unavailable the patient has an option to transmit via a landline telephone.
The modification that led to this submission was the change from a mobile platform with a Windows-based OS to one with an Android-based OS.
The provided document is a 510(k) premarket notification for the LifeWatch Technologies CG-6108 ACT-3L Continuous ECG Monitor and Arrhythmia Detector with Software Version 6.1.17. While it asserts substantial equivalence to a predicate device, it does not contain a detailed study report with specific acceptance criteria and performance data for the device's arrhythmia detection capabilities. Instead, it refers to internal validation reports and conformance to standards.
Therefore, the following information is based on what can be extracted from the document, with many fields indicated as "Not provided" because the detailed study information is not present in this summary.
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Arrhythmia Detection (General) | Not explicitly stated in terms of specific performance metrics (e.g., sensitivity, specificity for each arrhythmia type). The document implies meeting performance standards for arrhythmia detection algorithms. | The document states that the "Testing of the ACT-3L algorithm, LifeWatch Technologies, VATR-0164" was performed and passed, indicating that the algorithm's performance was found satisfactory against internal criteria. |
| Wireless Co-existence | Not explicitly stated, but implied to meet an internal standard for compatibility. | "Wireless co-existence testing of the ACT-3L system, LifeWatch Technologies, VATR-0163" was performed and passed. |
| Software Validation | Not explicitly stated, but implied to meet an internal standard for software quality and functionality. | "SW Validation Test Report, LifeWatch Technologies, STR-0112-61170" was performed and passed. |
| Conformance to Standards | Adherence to various international and national standards (e.g., IEC 60601-1, ISO 14971, IEC 62304, ISO 10993-1, ANSI/AAMI EC57, IEC 60601-1-2, IEC 60601-1-8). | The device's design "conforms to the following voluntary standards" listed in Section VII, indicating successful testing against these standards' requirements. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide a sample size for the test set used to evaluate the arrhythmia detection algorithm, nor does it specify the data provenance (e.g., country of origin, retrospective/prospective). It refers to an internal report "Testing of the ACT-3L algorithm, LifeWatch Technologies, VATR-0164" but does not detail its contents.
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.
4. Adjudication Method for the Test Set
This information is not provided in the 510(k) summary.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not mention an MRMC comparative effectiveness study or any effect size of human readers improving with or without AI assistance. The focus is on the device's automatic detection capabilities and transmission to a monitoring center for professional analysis.
6. Standalone Performance
Yes, a standalone performance assessment of the algorithm was conducted. The document states:
"Testing of the ACT-3L algorithm, LifeWatch Technologies, VATR-0164" was performed and passed. This indicates that the algorithm's performance in detecting arrhythmias (Atrial Fibrillation, Tachycardia, Bradycardia, and Pause) was evaluated independent of human intervention.
7. Type of Ground Truth Used
The specific type of ground truth used for validating the arrhythmia detection algorithm is not explicitly stated in the summary. For ECG arrhythmia detection, common ground truths include expert consensus (manual review by cardiologists) on annotated ECG recordings or reference annotations from established databases. Given the nature of cardiac monitoring, it is highly likely that expert consensus on ECG segments served as the ground truth, but this is an inference, not a direct statement from the document.
8. Sample Size for the Training Set
The document does not provide information on the sample size for the training set used to develop or train the arrhythmia detection algorithm.
9. How the Ground Truth for the Training Set Was Established
This information is not provided in the 510(k) summary.
§ 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.