(43 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 Continuous ECG Monitor and Arrhythmia Detector is designed for selftesting 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 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 Patient and Physician manuals are being modified to change a warning to allow the use of the ACT-3L on patients with an Implanted Cardioverter Defibrillator (ICD) if specific precautions are observed.
The provided document is a 510(k) summary for the CG-6108 ACT-3L Continuous ECG Monitor and Arrhythmia Detector. It primarily focuses on demonstrating substantial equivalence to a predicate device after a modification related to device labeling.
However, the document does not contain specific acceptance criteria, detailed results of a study proving the device meets acceptance criteria, sample sizes for test sets, data provenance, number or qualifications of experts for ground truth, adjudication methods, details of MRMC studies, standalone performance data, or training set information.
Instead, it states that the modification required "ACT-3L High Voltage Pulse Test, Card Guard document # ENTR-0112" and "ACT-3L EMC Dipole Antenna Test, Card Guard document # ENTR-0113" were performed to support the labeling change. It also indicates that the device conforms to various performance requirements and voluntary standards, including ANSI/AAMI EC57:1998 (R) 2008 for "Testing and reporting performance results of cardiac rhythm and ST segment measurement algorithms."
Without access to the specific internal Card Guard documents (ENTR-0112 and ENTR-0113) or detailed performance reports against standards like ANSI/AAMI EC57, it's impossible to fully answer your request.
Based only on the provided text, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document mentions compliance with "applicable performance requirements contained in and referenced in this document" and voluntary standards. However, it does not explicitly list acceptance criteria or provide a table of reported device performance against those criteria. It only states that the device "conforms" to these standards.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in the provided text.
- Data Provenance: Not specified in the provided text.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not specified in the provided text. The document refers to "professional analysis" by a "Monitoring Center" and "medical practitioner for evaluation" in the context of device use, but not for establishing ground truth for a test set in a performance study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not specified in the provided text.
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
- MRMC Study: Not mentioned or implied in the provided text.
- Effect Size: Not applicable as an MRMC study is not indicated.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document mentions the device "automatically generates an alarm triggered by an arrhythmia detection algorithm". Given the context of a 510(k) for an arrhythmia detector, it's highly probable that standalone algorithm performance was evaluated against standards like ANSI/AAMI EC57. However, the details of such a standalone study (e.g., specific metrics, dataset, outcomes) are not provided in this summary.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not specified in the provided text. For arrhythmia detection, ground truth is typically established by expert cardiologists reviewing ECG waveforms. The reference to ANSI/AAMI EC57 implies such a standard methodology would be followed, but the specifics are not in this document.
8. The sample size for the training set
Not specified in the provided text. The document focuses on modifications to an existing device, and for the core arrhythmia detection algorithm, the training would have occurred much earlier for the predicate device.
9. How the ground truth for the training set was established
Not specified in the provided text.
§ 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.