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The MotionWatch and PRO-Diary are compact, lightweight, body-worn activity monitoring devices that may be used to document physical movement associated with applications in physiological monitoring. The devices are intended to monitor limb or body movements during daily living and sleep. The MotionWatch and PRO-Diary can be used to assess activity in any instance where quantifiable analysis of physical motion is desired.

Additionally, the PRO-Diary has a built-in score pad that allows the wearer to subjectively assign and enter responses to pre-programmed questions. The score pad can be used as a substitute or in addition to the traditional written patient diary in conjunction with activity monitoring.

MotionWatch and PRO-Diary are compact, ambulatory, battery-operated activity recorders with physical characteristics similar to a small wristwatch.

The MotionWatch and PRO-Diary are intended for the acquisition and analysis of the physical activity of the body during daily living and sleep. The MotionWatch and PRO-Diary use state of the art miniature accelerometer technology to measure movements of the limb or torso and store these data within the devices differ in that the MotionWatch incorporates an ambient light sensor whereby the PRO-Diary incorporates a display and score-pad to allow subjective inputs.

The MotionWatch and PRO-Diary require operational software to allow configuration. data download, storage and off-line analysis of activity data by a health, care provider. The software can be run on an IBM-Compatible PC and the device is connected directly by means of a standard Universal Serial Bus connection for configuration and download.

The MotionWatch and PRO-Diary utilize a motion sensor known as an "accelerometer" to measure the occurrence and degree of motion. The sensor is a solid state device with a digital output directly proportional to physical acceleration in 1, 2 or 3 axes of orientation. The acceleration data are processed into "counts" before being stored in the non-volatile memory of the device.

Here's the breakdown of the acceptance criteria and the study details for the MotionWatch and PRO-Diary devices, based on the provided text:

Acceptance Criteria and Device Performance

The provided document details non-clinical performance testing for both the MotionWatch and PRO-Diary. The acceptance criteria and reported device performance are presented below. It's important to note that these are engineering performance specifications rather than clinical study endpoints.

MotionWatch Non-Clinical Performance Testing:

PRO-Diary Non-Clinical Performance Testing:

Study Details:

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

• Sample Size: The document repeatedly refers to "a sample of devices" or "a sample device" for testing. However, no specific number for the sample size (i.e., how many individual devices were tested) is provided for any of the performance tests.
• Data Provenance: Not explicitly stated. Given the submitter's address (CamNtech, UK, Ltd. ... Cambridge, United Kingdom), the testing was likely conducted in the United Kingdom. The study appears to be a prospective series of engineering validation tests rather than a retrospective analysis of existing data.

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

• Not applicable. The "ground truth" in this context refers to the verifiable physical conditions (e.g., applied acceleration, light levels) used to test the device's accuracy. These are objective measurements rather than subjective expert interpretations. In the case of the PRO-Diary's subjective input test, the written log serves as the ground truth, which is a direct record.
• No human experts were used to establish the "ground truth" for the device's physical performance characteristics.

4. Adjudication Method for the Test Set:

• Not applicable. This was not a clinical study involving subjective measures or ambiguous data interpretation requiring adjudication. The pass/fail criteria are objective and directly measured against known physical inputs or comparisons to a reference (e.g., calibrated light meter, written log).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:

• No such study was conducted or reported. The devices (MotionWatch and PRO-Diary) are activity recorders. They collect raw physical movement data and, in the case of the PRO-Diary, subjective inputs. They do not employ AI or machine learning for interpretation, nor do they involve "human readers" interpreting data in a diagnostic or assessment capacity where AI assistance would be relevant for improvement. The document describes basic device performance validation.

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

• Yes, in essence. The entire performance testing described is "standalone" in the sense that it evaluates the device's inherent ability to measure and record physical parameters and, for the PRO-Diary, to record subjective input accurately. There is no "human-in-the-loop" performance being measured in these engineering validation tests, other than a human observing a display's legibility or comparing a written log (for the PRO-Diary's subjective input feature).

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

The ground truth used for these performance tests includes:

• Simulated reference acceleration: For accuracy and frequency response of acceleration measurements.
• Absence of physical stimulus: For zero count output.
• Calibrated light meter: For light sensor accuracy.
• Total darkness (covered sensor): For zero lux output.
• Controlled power on/off events: For recovery after reset.
• Written log: For the accuracy of subjective input recording and display on the PRO-Diary.

8. The Sample Size for the Training Set:

• Not applicable. These devices are not AI/ML-based systems that require a training set. They are hardware devices with embedded software for data acquisition and storage, validated through direct physical performance testing against known inputs.

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

• Not applicable. As there is no training set for an AI/ML algorithm, no ground truth needed to be established for one.

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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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