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The purpose of the TCx-I Remote Care Management System is to collect and transmit medical information such as weight, blood pressure and pulse rate, and blood glucose and other devices from the patients on completion of their testing and transmit these results to their healthcare provider at another facility. The system supports videoconferencing, multimedia education and messages. This system is installed by or with support from trained professionals. This device is not intended to provide time sensitive data or alarms. This system may not be used as a substitute for direct medical intervention or emergency care. Interpretation of the information collected and transmitted requires clinical judgement by an experienced medical professional.

TCx-I Remote Care Management system collects and transmits measurement information such as weight, blood pressure and pulse rate, and Blood Glucose data from the patients on completion of their testing and transmit these results to their healthcare provider at another facility.

This 510(k) summary does not contain the kind of detailed information about acceptance criteria and specific study results that you are requesting. This document is a declaration of substantial equivalence, which focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than proving performance against specific acceptance criteria with detailed clinical studies.

Here's why the requested information cannot be extracted from the provided text:

• No acceptance criteria tables or performance data: The document discusses "Software verification and validation" and "Electrical safety and Electromagnetic compatibility tests" but provides no specific acceptance criteria (e.g., accuracy, sensitivity, specificity, data transmission rates, error rates) or the quantitative results of these tests.
• No clinical or comparative effectiveness study details: The submission explicitly states "Summary of nonclinical testing," indicating that the verification and validation were primarily non-clinical. There is no mention of studies involving human subjects for evaluating the device's performance, let alone multi-reader multi-case (MRMC) studies or standalone algorithm performance.
• Focus on data transmission, not diagnostic accuracy: The device, TCx-I Remote Care Management system, is described as a system to "collect and transmit measurement information such as weight, blood pressure and pulse rate, and Blood Glucose data." Its function is data transfer, not making diagnostic interpretations itself. Therefore, concepts like "ground truth," "expert consensus," "sample size for test/training sets," or "adjudication methods" for diagnostic accuracy are not relevant to the described function of this device and are not elaborated upon. The document clearly states, "Interpretation of the information collected and transmitted requires clinical judgement by an experienced medical professional."

In summary, the provided text establishes substantial equivalence for a data transmission system through non-clinical testing, but it does not detail performance acceptance criteria or provide the results of clinical studies to prove those criteria are met for diagnostic or interpretative purposes.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or answers to the other specific questions about studies, ground truth, and expert involvement, as this information is not present in the provided 510(k) summary.

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