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510(k) Data Aggregation
(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.
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(27 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.
The CG-6108 ACT-3L is designed for self-testing by patients at home and for analysis by medical professionals at a remote Monitoring Center. It comprises a chest-worn ECG sensor and a handheld device with a proprietary application, configured to process and transmit the ECG recordings.
The chest-worn unit has 3 electrodes on a harness and it houses a battery, an ASIC and a Bluetooth transceiver for the acquisition, recording, and transmission of the ECG signal.
The ECG signals are transmitted via Bluetooth to the handheld device. When an event is detected it is wirelessly transmitted to the CG Monitoring Center for professional analysis. The handheld device is equipped with shared memory used to received from the sensor and to allow preand post processing options through the use of this memory in a dual memory loop configuration, both running in parallel. One loop is auto-triggered, with programmable that starts recording based on specific rhythms detected or manually activated by the patient. The second, and longer, recording loop is controlled to provide the physician with more information, when requested by the CG Monitoring Center.
The handheld device automatically transmits the recorded ECG, via cellular link, to the Monitoring Center. When cellular service is unavailable the patient can transmit via landline telephone.
Here's an analysis of the provided text regarding the acceptance criteria and study for the CG-6108 ACT-3L Continuous ECG Monitor and Arrhythmia Detector:
CG-6108 ACT-3L Continuous ECG Monitor and Arrhythmia Detector: Acceptance Criteria and Study Details
The provided 510(k) summary (K081257) does not explicitly detail acceptance criteria or the specifics of a study proving the device meets those criteria, particularly regarding the arrhythmia detection algorithm's performance. It primarily focuses on the device's intended use, principles of operation, and its substantial equivalence to predicate devices, referencing compliance with various general medical device and quality management standards.
However, based on the information provided and common practices for arrhythmia detectors, we can infer some aspects and highlight what is missing.
Missing Information: A critical piece of information that is not present in this summary is a direct table of acceptance criteria for the arrhythmia detection performance (e.g., sensitivity, specificity for specific arrhythmias) and the corresponding reported device performance from a clinical or analytical study. The document states that "All Verification, Validation and Testing (VV&T) documents - although not included in this dossier, constitute a part of the device DMR and are available upon request." This indicates that such data exists but is not publicly available in this filing.
Inferred/Identified Information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
As mentioned, a specific table for acceptance criteria of the arrhythmia detection algorithm is not provided in this 510(k) summary. The document focuses on compliance with general medical device standards.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the 510(k) summary. The document does not describe a performance study for the arrhythmia detection algorithm.
3. Number of Experts Used to Establish Ground Truth for the Test Set and 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
A MRMC comparative effectiveness study is not mentioned or described in the 510(k) summary. The document primarily focuses on the device's technical specifications and safety standards rather than human-in-the-loop performance studies.
6. Standalone (Algorithm Only) Performance Study
A standalone performance study for the algorithm is not explicitly detailed in the 510(k) summary.
However, the "Arrhythmia Detector and Alarm Guidance for Industry and FDA Staff Class II Special Controls Guidance" and "ANSI/AAMI-EC 57:1998, Testing and Reporting Performance Results of Cardiac Rhythm and ST Segment Measurement Algorithms" are referenced as standards. These standards typically require performance metrics for arrhythmia detection. The absence of these results in the summary suggests they would be in the "VV&T documents" mentioned.
7. Type of Ground Truth Used
This information is not provided in the 510(k) summary. For arrhythmia detectors, ground truth is typically established by an expert cardiologist's review of the ECG recordings, sometimes with the aid of adjudicated annotations from multiple experts.
8. Sample Size for the Training Set
This information is not provided in the 510(k) summary.
9. How the Ground Truth for the Training Set Was Established
This information is not provided in the 510(k) summary.
Summary of What Can Be Inferred/Found:
- Acceptance Criteria & Performance: Not explicitly stated for the arrhythmia algorithm. Compliance with general safety and electrical standards (IEC, EN, ISO) is stated, but these are not performance criteria for arrhythmia detection.
- Study Details (Test Set, Experts, Adjudication, MRMC, Standalone, Ground Truth): Not provided in this 510(k) summary. This information is likely contained within the "Verification, Validation and Testing (VV&T) documents" which were not part of the public dossier.
- Training Set Details: Not provided.
- Referenced Standards Indicating Expected Performance: The reference to "ANSI/AAMI-EC 57:1998, Testing and Reporting Performance Results of Cardiac Rhythm and ST Segment Measurement Algorithms" strongly suggests that the device's arrhythmia detection algorithm was tested against the performance metrics outlined in this standard (e.g., detection rates for various arrhythmias, false positive/negative rates). However, the results of such testing are not presented in this document.
Conclusion: The provided 510(k) summary (K081257) for the CG-6108 ACT-3L focuses on regulatory compliance and the device's technical description for establishing substantial equivalence. It does not contain specific details regarding the acceptance criteria or the results of a study demonstrating the device's performance for its arrhythmia detection algorithm. Such information would typically be found in the detailed V&V reports that were part of the full submission but not included in this public summary.
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