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The Ventoux is intended to provide continuous or intermittent mechanical ventilation support for the care of individuals who require mechanical ventilation. Specifically, the Ventoux is applicable for adult and pediatric (i.e., infant, child and adolescent) patients who weigh at least 5 kg (11 lbs).

The Ventoux is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician; it is suitable for use in hospital environments.

The Ventoux Ventilator is an electrically powered, microprocessor-controlled multi-parameter ventilator, which can be: Time, Pressure, Flow or Volume triggered; Volume or Pressure controlled; Time or Flow cycled.

Manual inflation is allowed, and the Ventoux supports the emergency intake of ambient air which permits the patient to pull ambient air into the breathing circuit in the event of a complete loss of air/gas supply.

Volume triggered is based on Inspiratory trig response time ≤100 ms from pressure drop/flow rise to PEEP level.

Ventilation is possible in both Invasive and Noninvasive settings.

The system can be expanded to include additional parameter monitoring to allow for Sp02, etC02 and Cuff Pressure Control.

The Ventoux can be powered by external power (100 – 240 VAC, 50-60 HZ or 10 – 30 VDC) and/or by its two swappable internal Li Ion rechargeable batteries, which provide full operating power the to the ventilator for a minimal operating time of 6 hours when operating on standard ventilation parameters.

A comprehensive alarm system is built-in to alert the user to violations of set safety limits. The alarm system alerts the care giver by activating the audible alarm, screen display and the LED indicator.

The electrical system is comprised of three primary boards: The main board (motherboard) which holds the majority of the electronics including the main CPU and the display CPU. the power board, which holds the power subsystems, and internal communication functions, and the Communication board, which holds internal communication and external communication connectors. The main component of the pneumatic system is an electrically controlled compressor (pump). This compressor provides a compressed gas source so no external air compressor is needed. Additionally, the exhalation valve is activated by an electrically controlled proportional solenoid that provides a built in PEEP.

The provided FDA 510(k) summary (K223120 for the Ventoux Ventilator) does not contain information about an AI/ML powered device. The document describes a traditional medical device (a continuous ventilator) and its comparison to predicate devices based on established engineering and performance standards.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, human reader improvement with AI assistance, or ground truth establishment for an AI/ML model. The 510(k) summary specifically states:

"No clinical testing was conducted or required in support of this premarket notification." and "The software design and validation process, together with the bench testing of the device, demonstrated Ventoux Ventilator performs as intended."

This indicates that the device's performance was validated through bench testing and compliance with recognized standards, not through studies involving AI/ML performance metrics, expert consensus, or multi-reader studies as would be typical for AI-powered diagnostic aids.

The document focuses on:

• Technological Characteristics Comparison: Showing the Ventoux has similar features and functionalities to predicate devices.
• Performance Data: Demonstrating compliance with various IEC and ISO standards related to electrical safety, EMC, basic safety and essential performance of ventilators, alarm systems, gas monitors, pulse oximeters, environmental testing (shock, rough handling, vibration), altitude, internal temperature, and battery validation.
• Software Design and Validation: Stating that this was performed and contributed to demonstration of intended performance.
• Bench Testing: Stating that bench testing was conducted to verify compliance with predefined specifications and internal procedures.
• Biocompatibility: Assessment of gas pathways.

To answer your request, an AI/ML-specific device submission would be needed, which would detail metrics like sensitivity, specificity, AUC, and studies with expert readers. This document does not provide such information.

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