(183 days)
The BioSticker System is a remote monitoring system intended for use by healthcare professionals for continuous collection of physiological data in home and healthcare settings while the patient is at rest. This can include heart rate, respiratory rate, and skin temperature. Data are transmitted via wireless connection from the BioSticker for storage and analysis.
The device is intended for use on general care patients who are 21 years of age or older as a general patient monitor, to provide physiological information. The BioSticker System are intended for use by healthcare professionals as an aid to diagnosis and treatment.
The device is not intended to measure physiological parameters while the patient undergoes significant motion or is active. The device is not intended for use on critical care patients.
The BioSticker System is a remote monitoring system intended for use by healthcare professionals for continuous collection of physiological data in home and healthcare settings while the patient is at rest. This can include heart rate, respiratory rate, and skin temperature. Data are transmitted via wireless connection from the BioSticker for storage and analysis.
The provided text is a 510(k) clearance letter from the FDA for the BioSticker System. It primarily details the regulatory approval process and the intended use of the device. The document does not contain information about acceptance criteria, device performance studies, or ground truth establishment.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets them based on the provided input. The specific information you asked for (e.g., sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types) is not present in this regulatory document.
§ 870.2910 Radiofrequency physiological signal transmitter and receiver.
(a)
Identification. A radiofrequency physiological signal transmitter and receiver is a device used to condition a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g., a central monitoring station. The received signal is reconditioned by the device into its original format so that it can be displayed.(b)
Classification. Class II (performance standards).