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The VORTRAN GO2VENT with PEEP Valve is to be used by properly trained personnel to deliver emergency, shortterm, constant flow, pressure-cycled ventilatory support on patients weighing 10 kg and above.

The device consists of a modulator (an exhalation valve that opens at PIP and closes at PEEP), a mechanical manometer, a resistor (which is referred to as the PEEP Valve) attached within the exhalation path for elevating the PEEP further than can be set with the modulator, a patient connector tee to supply gas flow, entrain additional air, and connect to a face mask or a tube inserted into a patient's airway, and two associated accessories. It is intended to be used by properly trained personnel in any environment in which emergency ventilation is required.

The VORTRAN GO₂VENT with PEEP Valve provides short-term, constant flow, pressure-cycled ventilatory support in either pressure control or pressure support mode. In pressure support mode, the rate dial of the VORTRAN GO₂VENT with PEEP Valve is set so that the baseline pressure is set above the set PEEP. This allows the patient to initiate inhalation by drawing the baseline pressure down to the set PEEP. In pressure control mode, the device will automatically cycle between PIP and PEEP when connected to a patient's airway.

The working mechanism of the VORTRAN GO₂VENT with PEEP Valve consists of a moving diaphragm that opens the exhalation path when the pressure reaches PIP and closes when the pressure reaches PEEP. Without the PEEP Valve, PEEP will be approximately 20% of the set PIP. With the PEEP Valve attached, the PEEP will be increased from this value up to 24 cm-H₂O depending on the patient's compliance and the VORTRAN GO₂VENT with PEEP Valve's settings. The PEEP Valve is attached within the exhalation path by connecting it between the modulator and the patient connector tee. The pressure at which the diaphragm opens and closes against the valve is controlled by the amount of spring force acting against the diaphragm's movement. The spring force is adjusted by manually turning a threaded knob that varies the amount of spring compression.

The device is constructed of a variety of plastics such as K-Resin, HDPE, polycarbonate, and silicone, as well as copper beryllium springs. The VORTRAN GO₂VENT with PEEP Valve is an external communicating device with limited and prolonged tissue contact duration (up to 30 days) via the breathing gas pathway.

The associated accessories were included with the cleared predicate device (K162968) and include:

• . Elbow flex hose for connecting the patient connector tee to a face mask or a tube inserted into a patient's airway
• Oxygen tubing for connecting the patient connector tee to a gas supply

The provided text describes the 510(k) premarket notification for the VORTRAN GO2VENT with PEEP Valve. It includes information on performance testing which addresses acceptance criteria.

Here's a breakdown of the requested information based on the provided text:

1. Table of acceptance criteria and the reported device performance

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample size used for the mechanical performance testing. It also does not provide details on the data provenance, such as country of origin or whether the studies were retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable and not provided in the document. The device is a medical device, and its performance is evaluated against engineering and biological standards, not through expert-labeled data like in AI/imaging studies.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable and not provided in the document for the reasons stated above.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable. The device is a powered emergency ventilator, not an AI or imaging diagnostic tool that would involve human readers or AI assistance in interpretation.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This information is not applicable for the reasons stated above.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For biocompatibility, the "ground truth" was regulatory guidance and recognized ISO standards. For mechanical testing, the "ground truth" was compliance with internationally recognized ISO standards for lung ventilators and connectors.

8. The sample size for the training set

This information is not applicable as this is a medical device approval, not an AI/machine learning model.

9. How the ground truth for the training set was established

This information is not applicable as this is a medical device approval, not an AI/machine learning model. The relevant "ground truth" for compliance was established through recognized international standards.

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