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The eCordum™ Cardiac Monitor is intended to record, transfer and store single-channel electrocardiogram (ECG) data via Bluetooth transmission to Bluetooth enabled devices. The monitor is intended for use by healthcare professionals, patients with known or suspected heart conditions and health conscious individuals. The ECG data is intended to supplement other patient data and is not intended for automated analysis. The device has not been tested and it is not intended for pediatric use.

The eCordum™ Cardiac Monitor (eCordum™ CM) is intended to record, transfer and store single-channel electrocardiogram (ECG) data via Bluetooth transmission to Bluetooth enabled devices. The monitor is intended for use by healthcare professionals, patients with known or suspected heart conditions and health conscious individuals. The device has not been tested and it is not intended for pediatric use.

The eCordum™ CM device is powered by a replaceable battery and has two interchangeable attachable covers with respective ECG electrodes for long-term ECG recording. The Wearable Unit for long-term recording is used with two standard disposable Off-The-Shelf (OTS) ECG electrodes. For long term recording ECG data is obtained by attaching the device to user's chest using OTS ECG electrodes. Long-term recordings provide a single channel ECG signal. During recording the device collects and encrypts ECG data in the storage media for unidirectional transmission to a Bluetooth enabled device.

The provided text describes the eCordum Cardiac Monitor (eCordum CM) and its substantial equivalence to a predicate device, the BodyGuardian System. However, it does not include detailed acceptance criteria or the specific study results that quantitatively prove the device meets these criteria in the format requested.

The document states that the device "passed all testing" and "met all the requirements," but it doesn't provide the actual performance metrics or the specific studies demonstrating these. It's focused on regulatory compliance and substantial equivalence rather than a detailed performance study with acceptance criteria and results.

Given the information provided, I can only extract what is implied to be the acceptance criteria (compliance with standards) and the general statement that the device met these.

Here's an attempt to answer based on the available information, with significant limitations due to the nature of the provided text:

1. A table of acceptance criteria and the reported device performance

Based on the provided text, the acceptance criteria are primarily compliance with relevant medical device standards. The performance is generally stated as "met all requirements" or "passed all testing."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify sample sizes for any test sets related to performance evaluation (e.g., number of ECG recordings, number of subjects). It also does not mention the data provenance (country of origin, retrospective/prospective). The testing appears to be primarily bench/laboratory testing based on standards, not clinical studies with patient data.

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 applicable. The document describes compliance with technical standards and software validation, not a study requiring expert-established ground truth for a test set of medical data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as there is no mention of a test set requiring adjudication of medical findings.

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 applicable. The eCordum Cardiac Monitor is described as a device that "records, transfers and stores single-channel electrocardiogram (ECG) data." It explicitly states, "The ECG data is intended to supplement other patient data and is not intended for automated analysis." Therefore, it does not involve AI for interpretation or assistance to human readers, and no MRMC study was conducted.

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

Not applicable. The device does not perform automated analysis or have an algorithm for interpreting ECG data. It is a data acquisition and transfer device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the tests described is the specifications and requirements of the relevant medical device standards (e.g., IEC 60601-2-47 for ECG performance, ISO 10993-1 for biocompatibility). The "truth" is whether the device's measured performance meets the predefined thresholds and parameters outlined in those standards.

8. The sample size for the training set

Not applicable. The eCordum CM does not use AI/machine learning, so there is no training set mentioned or implied.

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

Not applicable, as there is no training set for this device.

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