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The Actical is a compact, lightweight, waist-, wrist-, or ankle-worn activity monitor that may be used to assess human gross motor activity, caloric expenditure, and estimates of energy expenditure based on motor activity in any instance where quantifiable analysis of physical motion is desirable.

The subject device can be classified as physiological signal conditioner as described in 21 CFR 882.1845. Actical is a physiological data recorder consisting of a data recorder which can be worn on the waist (hip), wrist, or ankle of the subject and that detects, measures, and records physical Activity data. A Reader is used to transfer the recorded rata to a Personal Computer (PC) running the Actical Host software. The host software is used to configure the data recorder for data collection, to retrieve logged data from the recorder, to display data and trend graphs, and to provide a means to store the logged data in a PC for later use.

The provided text is a 510(k) summary for the Actical Physiological Signal Recorder. This document focuses on demonstrating substantial equivalence to predicate devices and does not contain detailed information about specific acceptance criteria, performance studies, or the methodologies used to establish ground truth.

Therefore, I cannot extract the requested information as it is not present in the provided text. The document primarily covers:

• Contact person and date
• Trade name, common name, classification, and product code
• Legally marketed substantially equivalent predicate devices
• Description of the device
• Intended Use
• Comparison of technical characteristics, stating that "Results of performance tests, risk analysis, and verification and validation testing demonstrate that the devices are substantially equivalent." However, it does not detail these tests, criteria, or results.
• FDA's letter of clearance, confirming substantial equivalence.

Without a detailed study report, specific acceptance criteria, sample sizes, expert qualifications, and ground truth methodologies cannot be described.

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