(113 days)
The Stealth™ Monitor is a prescription only single use, continuous recording ECG monitor that can be worn up to least 24 hours. It is indicated for use with patients where it would be desirable to record ECG signals for this period of time.
Stealth™ Monitor, Docking Cable and Display and Storage Device
The provided text is a 510(k) premarket notification letter from the FDA to Cardiac Insight Inc. for their Stealth™ Monitor. This document, while indicating the device's regulatory approval, does not contain the detailed information required to answer the request about acceptance criteria, study findings, and ground truth establishment for a device study.
Specifically, the document focuses on regulatory approval and equivalence to predicate devices, rather than providing a performance study report.
Therefore, I cannot extract the requested information from the provided text.
§ 870.2800 Medical magnetic tape recorder.
(a)
Identification. A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.(b)
Classification. Class II (performance standards).