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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.

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