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The Care Team Portal is intended to support management of health conditions. It allows a clinical user to configure the collection of patient data. The Care Team Portal includes the ability to notify the patient and the clinical user when the parameters fall outside set limits and customize patient specific recommendations.

Vivify Remote Patient Monitoring consists of the Care Team Portal, patient portals, and accessory devices.

The Care Team Portal allows the clinical user to view and manage patient information. The functionality includes the ability to add new users and patients, ability to schedule video visits, secure in-app messaging, configure the collection of patient data leveraging care pathways survey questions, educational content and videos with customized notifications, and prioritize patients. It provides a dashboard view of the patients being monitored.

The patient portals enable the patient to provide subjective symptom or health status information that assists the care team in supporting the management of health conditions:
+Home is an option that provides the patient with software pre-loaded on a tablet that allows them to navigate through care pathways for the collection of patient data and view educational content related to their health condition.
+Go is designed for patients to download the software to their own mobile device to navigate through care pathways for the collection of patient data and delivery of educational content related to their health condition.
+Voice allows patients to answer their pathways questions and enter data using their phone.

Accessory devices can be connected to the system to allow for collection of vital signs or used independently to allow for manual input.

The provided text does not contain information about acceptance criteria and a study that proves a device meets those criteria for an AI/machine learning medical device.

The document discusses the Vivify Health, Inc. Care Team Portal, which is a Remote Patient Monitoring System. This system is software-only and designed to help clinical users manage health conditions by configuring the collection of patient data, notifying them when parameters fall outside set limits, and customizing patient-specific recommendations.

The 510(k) summary compares the Vivify Care Team Portal to a predicate device, the Philips (Visicu) eCare Coordinator (K171029). The document states that clinical studies were not required to demonstrate substantial equivalence, and that the device was verified and validated through internal functional, system-level, and usability testing.

Therefore, none of the specific questions regarding acceptance criteria for an AI device, sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance can be answered from this text. The document explicitly states: "Clinical studies were not required to demonstrate substantial equivalence of the Care Team Portal." and "Results from internal verification and validation testing established that the device meets its design requirements and intended use, that it is as safe, as effective, and performs as well as the predicate devices, and that no new questions of safety and effectiveness were raised."

This suggests that the "Care Team Portal" is primarily a data management and notification system, rather than an AI-driven diagnostic or prognostic tool that would typically require the detailed performance studies you've inquired about.

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