(84 days)
MedVizer™ ViTelCare Patient Monitoring System is intended to be used as a tool for an in-home patient that acquires, accumulates, and transmits a continuous self-assessment of physical condition, and other physiological vital signs information to a healthcare practitioner located remotely from the patient. The patient data is transmitted to the MedVizer™ ViTelCare Call Center where a qualified healthcare practitioner can review the patient information and data. The healthcare practitioner can contact the patient directly through a videoconference connection. The communication connectivity between patient and healthcare practitioner is via a standard public telecommunications utility to the Internet. Decisions concerning diagnosis and treatment are to be performed by qualified healthcare professionals.
MedVizer™ ViTelCare Patient Monitoring System is a PC based telemedicine system adapted to the collection, management, and communication of patient monitoring data from home and group care environments.
The provided document is a 510(k) summary for the MedVizer™ ViTelCare Patient Monitoring System. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, or multi-reader multi-case studies.
Therefore, I cannot fulfill the request for information on acceptance criteria and study details based on the provided text. The document focuses on regulatory submission and equivalence rather than performance evaluation.
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).