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The CG-6108 ACT-1L Continuous ECG Monitor and Arrhythmia Detector are intended for use by patients who experience transient symptoms that may suggest cardiac arrhythmia. The device continuously monitors patient ECC, 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.

CG-6108 ACT-1L 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 3 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 or professional analysis. When cellular service is unavailable the patient has an option to transmit via landline telephone.

Here's an analysis of the provided text regarding the acceptance criteria and study for the CG-6108 ACT-1L Continuous ECG Monitor and Arrhythmia Detector:

The provided text focuses on a 510(k) summary for a modified device (CG-6108 ACT-1L) and states that the technological characteristics and principles of operation are the same as the predicate device. This often means that the original predicate device's performance data and acceptance criteria are largely being referenced or assumed. The document does not contain a detailed de novo study demonstrating the performance of this modified device against specific, new acceptance criteria, but rather references validation against existing guidance and standards.

Therefore, many of the requested items (sample size, expert qualifications, etc.) are not explicitly provided for the modified device's performance study within these documents. The provided information focuses on conformance to standards and validation of software/hardware, rather than a clinical effectiveness study with an independent test set and ground truth.

1. Table of Acceptance Criteria and Reported Device Performance

The document references existing performance standards and guidance. It does not provide a specific table of acceptance criteria for this particular submission or a direct report of device performance against such. Instead, it states conformance to:

• "Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm, October 28, 2003"
• "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, May 11 2005"
• ANSI/AAMI/ISO EC57:1998 (R) 2008: Testing and Reporting Performance Results of Cardiac Rhythm and ST Segment Measurement Algorithms
• ANSI/AAMI EC38:1998 Ambulatory Electrocardiograph

The document states: "Final testing of the system included various performance tests and software validation tests designed to ensure that the device meet all of its functional and performance requirements and is fit for its intended use."

Specific performance metrics of the device (sensitivity, specificity, accuracy for arrhythmia detection) are NOT provided in this document.

2. Sample size used for the test set and the data provenance

• Sample Size: Not specified in the provided document.
• Data Provenance: Not specified in the provided document. The device is manufactured in Israel, but the origin of any test data is not mentioned. It is unclear if it was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication method for the test set

• Adjudication Method: 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

• MRMC Study: No, an MRMC comparative effectiveness study is not mentioned in the provided document. This device is primarily a detector and transmitter of ECG data for medical professionals to evaluate, not a system assisting human readers directly in interpretation for a comparative effectiveness outcome as typically measured in an MRMC study. The device's algorithm detects events to trigger transmission, it doesn't provide a diagnostic interpretation for human readers to then improve upon.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Standalone Performance: The document states: "Arrhythmia Detection Algorithm Performance Validation". This indicates that the algorithm's performance was validated, which would typically be a standalone assessment. However, specific metrics (e.g., sensitivity, specificity, PPV, NPV for Atrial Fibrillation, Tachycardia, and Pause) are not provided in this summary.

7. The type of ground truth used

• Type of Ground Truth: Not explicitly stated. For "Arrhythmia Detection Algorithm Performance Validation" and conformance to ANSI/AAMI/ISO EC57, the ground truth would typically be established by expert cardiologists reviewing the ECG tracings and labeling arrhythmias. The document does not specify if pathology or outcomes data were used, which is less common for arrhythmia detection algorithms unless used for long-term prognosis.

8. The sample size for the training set

• Training Set Sample Size: Not specified. The document focuses on validation rather than the development or training process.

9. How the ground truth for the training set was established

• Training Set Ground Truth Establishment: Not specified.

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