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The PIM Systems are intended for use as a monitoring device, whereby a health care professional can, from a remote location, communicate with the patient between visits to gather blood pressure and pulse readings, as well as to listen to the patient's heart and lung sounds.

The Aviva Systems and the predicate devices listed above have the same intended use and very similar principles of operation and technological characteristics. Specifically, all three devices consist primarily of a blood pressure meter, a telephonic stethoscope, and a communications circuit. These devices are intended for use as monitoring devices, whereby a health care professional can, from a remote location, communicate with the patient between visits to gather blood pressure and pulse readings, as well as to listen to the patient's heart and lung sounds. None of the devices are intended to be used for diagnostic purposes.

In general, operation of the devices consists of: (1) establishing voice/video communication: (2) establishing communication between the sending and receiving units of a telephonic stethoscope; (3) obtaining and conveying a blood pressure and pulse reading; and (4) obtaining and transmitting heart or lung sounds.

The only difference from the Personal Telemedicine System is that the Aviva Systems contain a standards based (H.324) video phone instead of an older proprietary video phone. The difference from the PTM and Digital PTM is that the Aviva Systems include a video phone to be used with the PTM and Digital PTM. The Aviva Systems use the same blood pressure meter and the same telephonic stethoscopes as the predicate devices.

This 510(k) summary does not contain information regarding
acceptance criteria, device performance,
sample sizes, ground truth establishment, or any studies conducted (such as MRMC or standalone studies).

The document is a premarket notification for the American TeleCare's Aviva Systems, seeking substantial equivalence to previously marketed predicate devices. It focuses on describing the device's intended use, principles of operation, and technological characteristics, highlighting that it is a "Telemedicine Communications Module" used for remote monitoring and not for diagnostic purposes. The key difference mentioned is the use of a standards-based video phone in the Aviva Systems compared to older/proprietary models in the predicates.

Therefore, I cannot populate the requested table or answer the specific questions about studies, acceptance criteria, sample sizes, or ground truth from the provided text.

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