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The Actiwave Recorder is an ambulatory, body-worn, dermally-affixed, physiological signal and activity recorder. Actiwave is indicated for use in recording physiological waveforms and activity as part of a physiological recording system. The subject is not restricted to a medical environment. The subject may participate in normal activities while the Actiwave recorder is in place. Actiwave is a multi-use recorder. Actiwave may be used wherever quantifiable measurement of human physiological signal waveforms and/or activity are needed. Actiwave may be used in a clinical setting or in basic scientific research under the supervision of a trained clinician.

Activave is a compact, ambulatory, battery-operated physiological signal recorder. Actiwave is commonly known as an Ambulatory Electrocardiograph. Because of its small size and battery operation, Actiwave may be used in a clinical or non-clinical setting to record physiological signal waveforms while the patient is unattended. The device obtains its signal from the skin surface through the use of standard gel-type signal electrodes. Actiwave may be worn during daily activities and is fully ambulatory due to its small size and its battery-operated power source. Recorded data may be transferred later to a personal computer for storage and archiving. Actiwave does not provide any data viewing or data analysis functions.

Here's a breakdown of the acceptance criteria and the study details for the Actiwave™ device based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The provided text does not specify a sample size for a test set involving human subjects or data. The performance testing described is focused on the device's technical specifications and adherence to "Special Control" criteria. It is a non-clinical performance assessment.

• Sample Size (Test Set): Not specified (non-clinical performance testing).
• Data Provenance: Not applicable in the context of human data. The testing was a non-clinical assessment of the device's adherence to specific technical performance standards.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

The provided text does not mention the use of experts to establish ground truth for a test set. The performance evaluation was based on predetermined technical criteria defined in a "Special Control."

4. Adjudication Method for the Test Set

The provided text does not describe any adjudication method. The assessment was against predefined technical specifications, not human interpretation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The submission is for a device that records physiological signals and activity; it does not perform analysis or diagnosis, which would typically involve human readers. The performance evaluation was a non-clinical assessment of the device's technical specifications when compared to a predicate device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The device itself is a standalone recorder. The performance testing was of this standalone device's technical specifications. However, the term "standalone" in the context of AI performance usually refers to an algorithm's diagnostic or analytical capability. The Actiwave does not perform data viewing or data analysis functions; it is solely a recorder. Therefore, while the device's physical and electronic performance was assessed in a standalone manner (without a human interpreting its output), it's not a standalone AI algorithm performance study as commonly understood in this context.

7. The Type of Ground Truth Used

The "ground truth" for the performance testing of the Actiwave device was the technical specifications and test criteria outlined in the Special Control for this device type. This is a form of engineering or design "ground truth" rather than clinical ground truth (e.g., pathology, expert consensus on patient data).

8. The Sample Size for the Training Set

The provided text does not indicate a training set sample size. This device is a physiological signal recorder, not an AI algorithm that would typically require a training set of data. Its function is to acquire and log data based on established scientific principles of signal recording.

9. How the Ground Truth for the Training Set Was Established

Since there is no mention of a training set for an AI algorithm, there is no information on how ground truth for a training set was established. The device relies on fundamental scientific and engineering principles for signal acquisition and recording, not on machine learning from a data-driven training set.

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