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The VORTRAN® Cuff Inflator (VCI) is intended to measure and regulate the intra-cuff pressure of Endotracheal tubes, Tracheostomy tubes and Laryngeal Mask Airways (LMAs). The VORTRAN® Cuff Inflator (VCI) is used under medical supervision in hospitals, pre-hospital (EMS), extended care facilities, and outpatient clinics, where a patient may be intubated.

The VORTRAN® Cuff Inflator (VCI) is a disposable, hand-held measuring device intended to measure and manually regulate intra-cuff pressure of Endotracheal, Tracheostomy, and LMA tubes.

The provided text describes the VORTRAN® Cuff Inflator (VCI) and its substantial equivalence determination by the FDA. However, it does not detail a study that defines acceptance criteria and then proves the device meets those criteria in the way typically seen for AI/ML-driven medical devices (e.g., involving AI model performance metrics like sensitivity, specificity, AUC).

This document is a 510(k) summary for a mechanical device, a cuff inflator, not an AI/ML-driven device. Therefore, many of the requested criteria in your prompt (e.g., sample size for test/training sets, experts for ground truth, MRMC studies, standalone AI performance) are not applicable to the information provided in this document.

The "Performance Data" section (Section VIII) states: "Performance testing included manometer accuracy, inflation and deflation functions, and absence of leaks. The performance testing includes a comparison between the VORTRAN® Cuff Inflator (VCI) and its predicate and reference devices, Posey Cufflator and Hospitech AG Cuffill."

Based solely on the provided document, here's an attempt to answer your questions, acknowledging the limitations for a non-AI/ML device:

1. A table of acceptance criteria and the reported device performance

The document provides "Pressure Accuracy and Range" as key performance characteristics. While not explicitly stated as "acceptance criteria" with pass/fail thresholds in the provided text, these are the performance targets the new device aims to match or be equivalent to.

Note: The document states for "Pressure Range": "(1) range has no significant difference, in comparison to its predicate or reference devices, and does not raise different questions of safety and effectiveness." This indicates the 0-60 cm-H2O range was deemed acceptable relative to the predicate/reference devices.

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

• Sample Size: Not specified in the document. The performance testing is described generally ("Performance testing included manometer accuracy, inflation and deflation functions, and absence of leaks.").
• Data Provenance: Not specified. Given it's a technical performance test, it's likely lab-based and conducted by the manufacturer.
• Retrospective/Prospective: Not applicable in the context of device performance testing in this document.

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)

• Not applicable/Not specified. The ground truth for manometer accuracy, inflation/deflation function, and leak absence would be established by calibrated instruments and engineering measurements, not human expert consensus, for a mechanical device.

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

• Not applicable. This is not a human-reader study requiring adjudication.

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 MRMC study was done, as this is a mechanical device, not an AI-assisted diagnostic tool.

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

• Not applicable. This is a mechanical device. Its performance is its standalone performance. There is no "algorithm" in the AI sense.

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

• For the performance characteristics mentioned (manometer accuracy, inflation/deflation, leaks), the ground truth would be established by calibrated reference standards and engineering measurements. For example, manometer accuracy would be verified against a highly accurate master pressure gauge.

8. The sample size for the training set

• Not applicable. This is a mechanical device, not an AI model requiring a training set.

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

• Not applicable.

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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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