(141 days)
The CG-6108 system is an Arrhythmia ECG Event Recorder designed for self-testing by patients at home and for analysis by medical professionals at a remote Monitoring Center. It comprises a chestworn ECG sensor and a handheld device with a proprietary application, configured to process and transmit the ECG recordings.
The CG-6108 Arrhythmia ECG Event Recorder is intended for use by patients who experience transient symptoms that may suggest cardiac arrhythmia.
The CG-6108 system is an Arrhythmia ECG Event Recorder designed for self-testing by patients at home and for analysis by medical professionals at a remote Monitoring Center. It comprises a chestworn 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 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 thresholds, that starts recording based on specific rhythms and arrhythmias 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 is a 510(k) summary for the CG-6108 Arrhythmia ECG Event Recorder. It describes the device, its intended use, and claims substantial equivalence to predicate devices, but does not contain a study or data proving that the device meets specific acceptance criteria in terms of diagnostic performance (e.g., sensitivity, specificity for arrhythmia detection).
The document mentions that the PMP4 Medical Application, which is part of the CG-6108 system, "incorporates an algorithm specially developed for detection of arrhythmia artifacts, e.g., AF" and that "A detected artifact triggers transmission of the signal to the CG Monitoring Center for analysis." However, it does not provide any performance metrics for this algorithm.
Instead, the document focuses on demonstrating compliance with various general and medical device-specific standards (e.g., MDD 93/42/EEC, EN 60601-1 for safety and EMC).
Therefore, based on the information provided, it is not possible to fill out the requested information regarding acceptance criteria and a study proving device performance in terms of diagnostic accuracy or clinical effectiveness.
Here's what can be extracted based on the provided text, and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Diagnostic Performance) | Reported Device Performance |
|---|---|
| Not specified in the document. | Not specified in the document. The document states the device "incorporates an algorithm specially developed for detection of arrhythmia artifacts, e.g., AF," but no performance data (sensitivity, specificity, etc.) is provided. |
2. Sample size used for the test set and the data provenance
- Sample size for test set: Not specified.
- Data provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not specified. The document indicates that detected events are transmitted to a "CG Monitoring Center for professional analysis," suggesting human interpretation, but details about the experts or ground truth establishment are absent for any test set.
4. Adjudication method for the test set
- Not specified.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not specified. There is no mention of an MRMC study or an assessment of human reader improvement with AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not explicitly stated, but the document mentions an "algorithm specially developed for detection of arrhythmia artifacts." However, no performance metrics for this standalone algorithm are provided. The system is designed for "analysis by medical professionals at a remote Monitoring Center" after an event is detected by the device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not specified.
8. The sample size for the training set
- Not specified.
9. How the ground truth for the training set was established
- Not specified.
Summary of what's provided for safety and regulatory compliance, not diagnostic performance:
The document primarily focuses on demonstrating:
- Intended Use: For patients experiencing transient symptoms suggesting cardiac arrhythmia.
- Classification: Class II device, product code DXH (Telephone Electrocardiograph Transmitters and Receivers).
- Substantial Equivalence: Claimed to predicate devices from Card Guard for memory loop monitoring, arrhythmia artifact detection algorithm (CG-6550 K003220 for AF detection algorithm), and Bluetooth transmission/software (PMP4 SelfCheck ECG K042254).
- Compliance with Standards: Meeting various international and European standards for medical devices, electrical safety, quality management, and risk management (e.g., MDD 93/42/EEC, EN 60601-1, EN ISO 13485, EN ISO 14971). These standards relate to device safety and manufacturing, not diagnostic accuracy of the arrhythmia detection algorithm.
§ 870.2920 Telephone electrocardiograph transmitter and receiver.
(a)
Identification. A telephone electrocardiograph transmitter and receiver is a device used to condition an electrocardiograph signal so that it can be transmitted via a telephone line to another location. This device also includes a receiver that reconditions the received signal into its original format so that it can be displayed. The device includes devices used to transmit and receive pacemaker signals.(b)
Classification. Class II (performance standards).