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The Servo' Ventilator System is intended for treatment and monitoring of patients in the range of neonates, infants and adults with respiratory failure or respiratory insufficiency. Servo' is a ventilator system to be used only by health care providers in hospitals or health care facilities and for in-hospital transport.

The ventilator is a ventilator with several selectable modes to individually monitor and treat patients whom needs respiratory assistance. The ventilator is the same as described in the notification K010925 and K022132 (addition of BiVent mode and CO2 module).

The provided text is a 510(k) summary for a Special 510(k) submission for the Servo-i Ventilator System. It focuses on a minor modification to the device, specifically changing the low minute volume alarm for infants. Crucially, the document does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as requested.

The 510(k) submission is for a modification to an existing device (Servo-i Ventilator System) and claims substantial equivalence to previously cleared devices (K010925 and K022132 for Servo-i, and K970839 for Servo Ventilator 300 A). The core of this particular submission is that the low minute volume alarm for infants has been changed from 0.10 l/min to 0.06 l/min, to match that of the predicate device, the SV300 ventilator.

Therefore, I cannot provide the requested information from the given text.

This document is a regulatory submission for a minor device change, not a detailed study report on novel device performance or AI/algorithm effectiveness. Such a document would typically not contain the robust clinical study data requested.

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