(87 days)
The ActiTrac is a small wrist-worn activity monitor designed for documenting physical movements associated with applications in physiological monitoring. The device is intended to be used to analyze circadian rhythms, automatically collect and score data for sleep parameters. These parameters, representing the number and intensity of limb movements, are directly correlated to sleep efficiency. The unit can also be used to assess activity in any instance where quantifiable analysis of physical motion is desirable.
The ActiTrac is a compact, wrist-worn, battery-operated activity monitor whose physical characteristics are similar to a small wristwatch. The monitor consists of the activity monitor itself and a wrist band. The ActiTrac is intended for the measurement, storage, and analysis of body activity. The ActiTrac can be attached to the subject's limb and through the use of an accelerometer, motion of that limb is measured, the activity stored within the activity monitor. A computer program is used to set up the ActiTrac to collect data. This program runs on an IBM-compatible personal computer (PC). The major functions of the application software are to program the device to collect data, retrieve the data from the activity monitor, display the data, and to store the data for future reference and comparison. The ActiTrac uses a smart download cable to provide a communications link between the ActiTrac and the PC. The ActiTrac utilizes a motion sensor known as an "accelerometer" to monitor the occurrence and degree of motion. This type of sensor provides an analog signal where the amplitude and speed of motion produces a signal whose magnitude and duration depend on the amount of motion. The activity signals are amplified and digitized by the on-board circuit. This information is stored in memory on board the device as activity counts. Activity can alternatively be stored in units of milli-g.
Here's an analysis of the provided text, focusing on acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Accelerometer sensitivity |
§ 882.1400 Electroencephalograph.
(a)
Identification. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.(b)
Classification. Class II (performance standards).