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The MCT 3L (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 alert triggered by an arrhythmia detection algorithm, or generates an alert manually triggered by the patient, and transmits the recorded data transtelephonically to a monitoring center provides the ECG data to the medical practitioner for evaluation.

The MCT 3L (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.

The device has been validated for use on patients 6 years of age and older.

The MCT 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 MCT 3L does contain software. The device is not supplied sterile or intended to be sterilized by the operator prior to use, and is not intended for single use.

The provided text does not contain detailed acceptance criteria or a study proving the device meets specific performance criteria. Instead, it is a 510(k) summary for the LifeWatch Mobile Cardiac Telemetry 3 Lead (MCT 3L), which focuses on demonstrating substantial equivalence to a predicate device (K143359 CG-6108 ACT 3L).

Here's what can be extracted and what is not available based on your request:

1. A table of acceptance criteria and the reported device performance
This information is not provided in the document. The submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing specific performance metrics against pre-defined acceptance criteria for the new device's arrhythmia detection algorithm.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided. The document explicitly states: "No clinical data was necessary to support substantial equivalence of the proposed device compared to the predicate." Therefore, no test set for clinical performance is detailed. The only "testing" mentioned is bench testing for engineering standards and human factors for pediatric use.

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)
This information is not provided. As no clinical test set is mentioned, there is no discussion of ground truth established by experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. No test set is detailed.

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
This information is not provided. The device is an "Arrhythmia Detector and Alarm" that automatically generates alerts and transmits data to a monitoring center for "professional analysis." While it uses an "arrhythmia detection algorithm," the document does not describe it as an "AI" in the context of improving human reader performance. It functions more as an automated detection system.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device functions as a standalone algorithm for detection: "The device continuously monitors patient ECG, automatically generates an alert triggered by an arrhythmia detection algorithm..." However, the performance metrics of this standalone algorithm (e.g., sensitivity, specificity for various arrhythmias) are not detailed in the document. The alert then transmits data to a monitoring center, implying a subsequent human review.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided. Without a detailed clinical performance study, the type of ground truth used for evaluating the arrhythmia detection algorithm is not specified.

8. The sample size for the training set
This information is not provided. The document makes no mention of training data for the device's algorithms.

9. How the ground truth for the training set was established
This information is not provided. As no training set is mentioned, how its ground truth was established is also not discussed.

Summary of Device Performance/Validation provided:

The submission focuses on demonstrating substantial equivalence to a predicate device (K143359 CG-6108 ACT 3L). The key statements related to performance and validation are:

• "The Indications for Use for the proposed MCT 3L device are identical to those of the predicate device with the exception that use for pediatrics age 6 and older is not excluded in the MCT 3L labeling."
• "Bench testing of the proposed MCT 3L was conducted to demonstrate substantial equivalence to the predicate device."
• "Insignificant historical changes are listed within the device description. No changes have been made to the user interface, device algorithms, or applications software compared to the predicate device."
• "The proposed device has the same intended use and employs the same fundamental scientific technology."
• Non-Clinical Testing:
  • IEC 62366-1:2015 (human factors validation testing for pediatric use age 6-21 with adult caregivers)
  • ISO 14971:2012 (evaluation of use-related risks)
  • ANSI/AAMI/IEC 60601-1-2 Edition 4:2014-02 (Electromagnetic Compatibility)
  • Wireless Coexistence Testing (in accordance with FDA guidance)
• Clinical Testing: "No clinical data was necessary to support substantial equivalence of the proposed device compared to the predicate."

Essentially, the FDA clearance for K170565 relies on the demonstrated substantial equivalence to a previously cleared device (K143359), with specific non-clinical tests conducted to address a labeling change for pediatric use and ensure compliance with relevant engineering standards. The performance of the arrhythmia detection algorithm itself is presumed to be equivalent to the predicate device, given "no changes have been made to the user interface, device algorithms, or applications software compared to the predicate device."

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