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The Aviva SLX System is 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 SLX System and the predicate device (Aviva System) listed above have the same intended use and very similar principles of operation and technological characteristics. Specifically, both 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. Neither device is intended to be used for diagnostic purposes.

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

The only difference from the predicate Aviva System is that the Aviva SLX System has the capability to 1) transmit the blood pressure/pulse readings from the Patient Station to the Central Station and clear the readings from the blood pressure/pulse meter; and 2) obtain glucose readings from an off-the-shelf glucose meter plugged into the data port of the Patient Station and transmit those readings to the Central Station, as well as to clear the readings from the glucose meter. The Aviva SLX Systems use the same blood pressure meter and the same telephonic stethoscope as the predicate device.

The provided text does NOT contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the way a typical medical device study would.

Instead, the document is a 510(k) summary for the Aviva SLX Systems, which focuses on demonstrating substantial equivalence to a predicate device, not on proving new performance characteristics through independent studies with defined acceptance criteria.

Here's why the requested information cannot be extracted from this document:

• No acceptance criteria or performance study reported: The document states that the new device has "minor modifications" and "does not raise new questions of safety or effectiveness." This implies that extensive new performance studies (like those requiring acceptance criteria, sample sizes, ground truth, etc.) were not deemed necessary because the device is substantially equivalent to an already approved device.
• Focus on substantial equivalence: The core of this 510(k) filing is to show that the Aviva SLX System has the "same intended use and very similar principles of operation and technological characteristics" as the predicate device.
• Device purpose: The device is a "Telemedicine Communications Module" intended for monitoring and gathering basic physiological data (blood pressure, pulse, heart/lung sounds, glucose readings), not for diagnostic purposes. This type of device relies more on the accuracy and reliability of its integrated components (like blood pressure meters and stethoscopes which are often already cleared) and its communication capabilities, rather than a novel diagnostic algorithm that would require extensive clinical validation against a gold standard.

Therefore, I cannot populate the table or provide answers to most of your questions because the information is not present in the provided 510(k) summary.

Disclaimer: Without a formal performance study detailed in a 510(k) summary, specific acceptance criteria as you've outlined for diagnostic AI devices are not typically presented. Regulatory clearance for devices like the Aviva SLX often relies on demonstrating that the modifications do not negatively impact safety or effectiveness compared to a legally marketed predicate device.

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