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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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This Device is to be used by properly trained personnel to deliver emergency, short term, constant flow, pressure cycled ventilator support on patients weighing 10kg and above.

The VORTRAN® GO2VENT™ provides short term, constant flow, pressure cycled ventilatory support in either pressure control or pressure support modes on patients weighing 10kg and above. In the pressure support mode, the rate dial of the VORTRAN® GO2VENT™ is set so that the baseline pressure is above the set PEEP allowing the patient to initiate inhalation by drawing the baseline pressure down to the set PEEP. The device includes the pulmonary modulator (an exhalation valve that opens at PIP and closes at PEEP) and a patient connector tee to supply gas flow, entrain additional air, and provides a redundant pop-off valve for patient care. The working mechanism of the VORTRAN® GO2VENTTM consists of a moving diaphragm which adds or subtracts spring force when it is moved from a horizontal to a vertical position, the addition or subtraction of spring force will affect the PIP setting by 1~3 cm-H2O. The VORTRAN® GO2VENT™ will function in any position as long as the final adjustments are made in a secured position (strapped or taped to the patient). The VORTRAN® GO2VENT™ is not an ICU stand alone ventilator with multiple monitoring features. Set up and use of the VORTRAN® GO2VENT™ is simple. Set desired flow and adjust pressure dial to obtain desired I-time and/or tidal volume (see tidal volume chart in instructions), and adjust rate dial to obtain desired rate and I to E ratio.

The VORTRAN® GO2VENT™ is a powered emergency ventilator. The device was found substantially equivalent to its predicate device (VORTRAN® Automatic Resuscitator (VAR-Plus), K041473) based on non-clinical performance data and material biocompatibility.

1. Table of Acceptance Criteria and Reported Device Performance:

The device's acceptance criteria are based on compliance with the following standards:

• ASTM Designation: F 920 - 93 (Reapproved 1999): "Standard Specification for Minimum Performance and Safety Requirements for Resuscitators Intended for Use with Humans."
• ISO 10651-5: "Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 5: Gas-powered emergency resuscitators."

The table below summarizes some key operational characteristics of the device and how they compare to the predicate, demonstrating that the new device meets the same specifications:

In addition, specific modifications were tested:

• MR Conditional: The new beryllium-copper springs were tested according to ASTM F2052 and verified as MR Conditional for a static magnetic field of 3-Tesla or less, and a spatial gradient magnetic field of 10,000-gauss/cm or less.
• New Entrainment Connectors: All testing data showed that the change in the knobs for FiO2 delivery did not degrade performance and the device delivers the required specifications.
• New Beryllium-Copper Springs: Tested for performance and fatigue.

2. Sample size used for the test set and the data provenance:

The document concerns non-clinical performance testing only. There is no specific "test set" sample size in terms of clinical data or patient cases mentioned. The testing was conducted on the device itself and its components. The data provenance is from non-clinical laboratory testing performed by the manufacturer and a third-party (Shellock MR Testing for MR Conditional verification). The data is retrospective in the sense of comparing the new device against previously documented performance of the predicate device and established standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable, as this was a non-clinical device performance and material compatibility study, not an expert-driven ground truth establishment for a diagnostic or AI algorithm.

4. Adjudication method for the test set:

Not applicable, as this was non-clinical device performance testing against established standards and predicate device specifications, not a clinical trial requiring adjudication of patient outcomes or interpretations.

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:

No. This is not an AI-enabled device; it is a powered emergency ventilator. Therefore, no MRMC study or AI assistance evaluation was performed.

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

Not applicable. This is not an algorithm, but a medical device.

7. The type of ground truth used:

The ground truth for the device's performance is compliance with established engineering and medical device standards (ASTM F 920-93 and ISO 10651-5) and the performance specifications of the predicate device. Material compatibility was assessed against materials used in previously cleared devices.

8. The sample size for the training set:

Not applicable, as this is hardware medical device. There is no "training set" in the context of machine learning.

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

Not applicable, no training set or ground truth in the context of machine learning.

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