(151 days)
The CG-6108 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 a one lead 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 Continuous ECG Monitor and Arrhythmia Detector system 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 includes 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 record the signal received from the sensor and to allow pre- and 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 thresholds that starts recording based on specific rhythms detected or manually activated by the patient. The second, and longer, recording loop is controlled remotely 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.
The provided document, a 510(k) Summary for the CG-6108 Continuous ECG Monitor and Arrhythmia Detector, does not contain specific acceptance criteria, performance metrics, or details of a study designed to prove the device meets such criteria.
The document primarily focuses on establishing substantial equivalence to a predicate device and describing the device's functionality and intended use. It lists referenced standards but does not report the device's performance against them.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets or data provenance.
- Number/qualifications of experts for ground truth.
- Adjudication method.
- MRMC study details (effect size, improvement with AI).
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for training set.
- How ground truth for the training set was established.
The document states: "The CG-6108 device constitutes a safe and reliable means for self-testing by patients who experience transient symptoms that may suggest cardiac arrhythmia. The device is at least as safe, effective, and reliable as the cleared predicate devices." This is a conclusion about substantial equivalence, not a report of specific performance metrics against defined acceptance criteria from a study.
To obtain the information you're looking for, you would typically need access to the full 510(k) submission, including performance testing reports, which are not usually publicly disclosed in detail within the 510(k) summary document itself.
§ 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.