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The CareCompanion Patient Station is intended to be used in conjunction with the CareCompanion Nurse Station to provide two-way video, audio and data communications between the patient and the health care professional.

The CareCompanion Patient Station is used upon prescription of an authorized healthcare provider by patients where regular monitoring of vital signs information is indicated. The vital signs information includes: blood pressure, pulse rate, weight, blood glucose level, blood oxygen saturation level, blood alcohol level, pulmonary function parameters, cardiac function parameters, and heart, lung and bowel sounds. The information is collected from the CareCompanion Patient Station and transmitted over standard telephone lines to a health care professional.

The device does not send any real-time alarms. The device is a diagnostic aid. Clinical judgement and experience are required to check and interpret the information transmitted. The device is not intended as a substitute for medical care. The device is contraindicated for patients requiring direct medical supervision or emergency intervention.

The CareCompanion System consists of two components: a transportable Patient Station installed typically in a patient's home; and the Nurse Station, installed in a healthcare provider or professional caregiver's office. The two components communicate with each other through modems over standard telephone lines and transmit real-time video, audio and data between them.

The real-time video and audio communications allow the patient and the caregiver to view and speak with each other.

Using vital signs measurement devices integrated with the Patient Station, the Patient Station is designed to monitor the patient's blood pressure, pulse rate, blood glucose level, blood oxygen saturation level, blood alcohol level, pulmonary function parameters, cardiac function parameters, weight, and/or heart, lung and bowel sounds, and transmit this data to the Nurse Station. The data is displayed to the caregiver operating the Nurse Station and also automatically recorded in a patient information database. The heart, lung and bowel sounds may be listened to by the caregiver using a set of headphones supplied with the system.

The Nurse Station consists of two sub-components, the Nurse Station PC, which is a standard PC with supporting peripherals connected to a videophone, which provides the video conferencing functions for the Nurse Station. The Nurse Station PC may also operate as a standalone device for patient data management and record keeping functions.

The provided text describes a medical device, the "CareCompanion Nurse Station / CareCompanion Patient Station," and its approval process. However, it does not contain specific acceptance criteria, a detailed study report proving the device meets those criteria, or the types of information requested in your prompt (e.g., sample sizes, ground truth establishment, expert qualifications, MRMC studies, standalone performance, training set details).

The document is a 510(k) summary for a telehomecare system, primarily focusing on demonstrating substantial equivalence to a predicate device, rather than providing detailed performance study results against predefined acceptance criteria.

Therefore, I cannot populate the table or answer the specific questions based on the provided text. The relevant sections indicate "Performance Testing" was performed, but only state a general conclusion:

• Performance Testing: "Testing was performed to validate the functional performance of the CareCompanion. In particular, testing was performed with each vital signs measurement device to show that they operate equivalently when integrated with CareCompanion as when operated as independent devices. In addition, the CareCompanion Patient Station and the CareCompanion Nurse Station have been subjected to performance testing to applicable mechanical, electrical and environmental standards."
• Conclusion: "The results of the test indicate that the device is substantially equivalent to its predicate devices and does not raise any new questions of safety or effectiveness."

This indicates that internal validation was done, likely demonstrating that the integrated vital signs devices performed similarly to their standalone versions and that the system met relevant safety standards. However, actual performance metrics, acceptance criteria, study sizes, ground truth methods, or expert involvement are not detailed in this summary.

In summary, the provided document does not contain the information needed to answer your request about acceptance criteria and the detailed study proving the device meets them.

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