Merlin.net Virtual Device Engine (VDE) Model MN7000 with AI - Transtelephonic implantable pacemaker analysis system

Intended purpose

The Merlin.net™ Patient Care Network (PCN) is intended to allow clinicians to view and remotely monitor a patient's implanted heart device data and condition via the web portal by receiving the data from a compatible Abbott transmitter, programmer or mobile application and displaying it for review on Merlin.net™ PCN by authorised clinic personnel. The Merlin.net VDE Model MN7000 enables physicians and clinicians to remotely program certain compatible Abbott Medical cardiac implantable devices, allowing individualised device programming. For compatible Implantable Cardiac Montor (ICM) devices, the Classification using AI for Rhythm Evaluation (CARE) module integrated in the Merlin.net VDE MN 7000 is intended to identify false positive stored electrogram (SEGM) recordings of Atrial Fibrillation (AF) and Pause episodes and omit them from the Merlin.net™ PCN.

Functional description

The Merlin.net VDE Model MN7000 is a component that is part of Abbott's Merlin.net Patient Care Network (PCN) that enables authorised clinicians to remotely program certain compatible Abbott Medical cardiac implantable devices, allowing individualised device programming. The Device incorporates CARE AI models designed to omit false episodes from the Merlin.net PCN, reducing clinician review burden.