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The MISTRAL Universal Jet Ventilator is designed to use for short term application in bronchoscopy and laryngoscopy. Jet ventilation applied with the Mistral Universal Jet Ventilator is useful in airway surgery, as it is performed in thoracic surgery units and ENT surgery. Jet ventilation is the optimal ventilation technique during the application of LASER light, where the presence of an ETT bears the risk for ignition, airway fire and burn injuries. Jet ventilation is useful for the removal of foreign bodies from the airway (e.g. after accidental aspiration of foreign bodies) via rigid bronchoscopes, for supplemental oxygenation during lung surgery (when the operated lung must be recruited for additional oxygenation, but may not be ventilated conventionally for surgical reasons), for surgery of the lower trachea close to the carina (when during the reconstruction phase, no tight airway sealing can be achieved), for radiation therapy of lung metastasis (when the tidal movements of the chest during spontaneous respiration or conventional ventilation would preclude the focusing of the radiation beam onto the target.
The Mistral Universal Jet Ventilator is intended for use during bronchoscopy or laryngoscopy for applications up to 45 minutes duration on adults in a hospital or other clinical setting.

The MISTRAL is a Universal Jet Ventilator. Key features include airway pressure measurement using a high pressure resistant sensor, a medium sized screen display for ventilation parameters and airway pressure graphics, a built-in air/oxygen blender allowing concentrations between 21 and 100% oxygen with an oxygen sensor, a bypass flow outlet for mask ventilation, a microprocessor (H8 532) and memory (27C512, DS1386), and various sensors (200 cmH2O pp-pressure sensor, 72.5 PSI driving-pressure sensor). It also includes fault detection for sensors and gas input, alarm functions for high PP pressure, system malfunctions, ventilation issues, FiO2 not adjustable, low O2 pressure, low air pressure, low battery, power failure, and maintenance required, and error functions for sensor malfunctions.

The provided text is a 510(k) summary for the MISTRAL Universal Jet Ventilator. It focuses on describing the device, its functions, safety features, and how it compares to a predicate device (ACUTRONIC's VS-200s Universal Jet Ventilator) to establish substantial equivalence.

However, the summary does not contain information about specific acceptance criteria or an explicit study that proves the device meets such criteria. It details the device's design, features, and alarm functions, aiming to demonstrate its safety and effectiveness by comparison to a previously cleared device. There's no mention of performance metrics, sample sizes, expert ground truth, or adjudication methods for acceptance criteria for the MISTRAL device itself in the context of a dedicated performance study.

The document primarily acts as a detailed description for regulatory submission, highlighting technological characteristics and safety measures, rather than a report of a clinical or performance study with defined acceptance criteria.

Therefore, I cannot populate the requested table or answer the specific questions about acceptance criteria and a performance study based on the provided text. The document's purpose is to show technical equivalence, not to detail the results of a contemporary performance study against predefined criteria.

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