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ViTelCare™ Turtle 400 Patient Monitoring System is intended to be a communication tool for an in-home patient that acquires, accumulates, and transmits vital signs information, selfassessment of physical condition, and other physiological data to a healthcare practitioner located remotely from the patient. The patient information is received and stored on the MedVizer™ ViTelCare Call Center where a qualified healthcare practitioner can review the patient information and data. 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.

The ViTelCare™ Turtle 400 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 text is a 510(k) summary for the ViTelCare™ Turtle 400 Patient Monitoring System, and a letter from the FDA regarding its substantial equivalence. This document primarily focuses on describing the device, its intended use, and its substantial equivalence to a predicate device.

There is no detailed information provided in the given text regarding specific acceptance criteria, performance data, or a study that proves the device meets those criteria.

The document states: "The ViTelCare™ Turtle 400 Patient Monitoring System is virtually identical to the ViTelCare™ Patient Monitoring System. There are no technical differences with any implications for safety and effectiveness." This indicates that the device's acceptance was based on its substantial equivalence to a previously cleared device (K040581), rather than a new performance study with specific metrics.

Therefore, I cannot provide the requested information in a table format or answer the detailed questions about sample sizes, expert qualifications, adjudication methods, MRMC studies, or standalone performance. The document explicitly states that the device is "substantially equivalent" to a predicate device, implying that its performance is assumed to be similar to that of the predicate device, and no new performance data is presented in this summary.

Key takeaway from the provided document:
The device's acceptance is based on demonstrating substantial equivalence to a predicate device (ViTelCare™ Patient Monitoring System, K040581), not on new performance studies with specific acceptance criteria.

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