(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.
§ 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.