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The Esprit ventilator is a microprocessor controlled, electrically powered, mechanical ventilator. It is intended for use by qualified medical personnel in providing continuous or intermittent ventilatory support for adult and pediatric patients as prescribed by a physician. The Esprit Ventilator is intended for use in either invasive or non-invasive applications.

Esprit Respiratory Mechanics is a diagnostic tool that enables a clinician to take dynamic and static measurements of a patient's lung parameters. The following maneuvers can be performed using Esprit Respiratory Mechanics: Vital Capacity, Maximum Inspiratory Pressure, PO.1 (Pressure change after the first 100 milliseconds of inspiratory effort), Static Compliance and Resistance. These tools are used by clinicians to monitor a patient's respiratory status and are displayed on the Esprit User Interface both graphically and in text format. Respiratory Mechanics also calculates the following: Ti/Ttot, Peak Lung Flow, Dynamic Compliance and Resistance.

The provided text is a 510(k) summary for the Esprit Ventilator with Respiratory Mechanics. It does not contain information about the acceptance criteria and study details for an AI/ML powered device as requested in the input.

Therefore, I cannot fulfill the request using the provided text. The document describes a traditional medical device modification and its substantial equivalence to predicate devices, without any mention of AI or machine learning, or performance metrics against specific acceptance criteria for such technologies.

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