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The Viterion100 TeleHealth Monitor is a physiological monitoring system. The system collects, accumulates, transmits patient vital signs and other physiological data from a patient who may be remote from the healthcare practitioner to the practitioner, and provides communication between the patient and practitioner. It can record physiological information such as:

• Blood Pressure/Pulse
• Blood Hemoglobin Oxygen Saturation (SpO2)
• Body Weight
• Blood Glucose
• Temperature
• Respiratory Peak Flow

The Viterion 100 TeleHealth Monitor is a physiological monitoring system. The system collects, accumulates, transmits patient vital signs and other physiological data from a patient who may be remote from the healthcare practitioner to the practitioner, and provides communication between the patient and practitioner. The physiological monitoring instruments, selected by the healthcare practitioner, operate in conjunction with the Patient Terminal located in the patient's home, a hospital room, nursing home, or other healthcare facility. The Patient Terminal connects to the server via a conventional telephone line or through the Ethernet. The Viterion 100 TeleHealth Monitor system is a software controlled physiological monitoring device for which the healthcare provider is remotely located from the patient. It is a tabletop unit that communicates with the healthcare provider via a server. The built-in interface allows monitoring of the data directly from the selected physiological instruments. It also allows manual entry of other physiological measurements for those instruments that do not directly connect to the system.

This document is a 510(k) summary for the Viterion 100 TeleHealth Monitor. It describes the device's intended use and technological characteristics but does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as requested.

Therefore, I cannot provide the requested information based on the provided text. The document focuses on demonstrating substantial equivalence to predicate devices for regulatory approval, rather than detailing performance study outcomes.

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