(139 days)
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:
| Requirement Summary | Test/Verification Method | Pass/Fail Criteria | Test Result |
|---|---|---|---|
| Measure linear acceleration with an accuracy of +/-5% over the full range | Apply a range of simulated reference acceleration and record the results. | The recorded acceleration over the test range shall meet the requirement. | PASS |
| Accuracy shall be |
§ 882.5050 Biofeedback device.
(a)
Identification. A biofeedback device is an instrument that provides a visual or auditory signal corresponding to the status of one or more of a patient's physiological parameters (e.g., brain alpha wave activity, muscle activity, skin temperature, etc.) so that the patient can control voluntarily these physiological parameters.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter when it is a prescription battery powered device that is indicated for relaxation training and muscle reeducation and prescription use, subject to § 882.9.