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The Inspiration ® Ventilator is indicated for use with a wide range of patients from infant through adult, requiring respiratory support for a wide range of clinical conditions in hospital, hospital-type facilities and intra-hospital transport.

The Inspiration Ventilator System provides continuous ventilation to infant, pediatric and adult patients requiring respiratory support by means of pressure-based and volume-based mandatory and spontaneous breaths. The device is identical to the cleared device, the Inspiration Ventilator System, with the addition of the capability to deliver a Heliox gas mixture.

This modification is implemented on the Inspiration Ventilator through additional functionality in hardware and software. The existing modalities, pneumatic design, electrical circuitry and user interface mechanism have remained unchanged from the cleared Inspiration Ventilator device.

The provided text does not contain detailed information regarding specific acceptance criteria applied to the Inspiration® Ventilator System regarding its performance with Heliox, nor does it describe a study that explicitly proves the device meets such criteria with detailed performance metrics.

However, based on the available information, we can infer the primary "acceptance criterion" being evaluated is substantial equivalence to existing devices, particularly concerning the addition of Heliox gas mixture delivery. The text focuses on demonstrating that the device operates safely and effectively with Heliox, similar to its operation with air and 100% O2, and does not introduce new safety or effectiveness concerns.

Here's an attempt to structure the information based on your request, acknowledging the limitations of the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Since explicit numerical acceptance criteria for Heliox performance are not given, we will infer them from the safety and effectiveness claims.

2. Sample Size Used for the Test Set and Data Provenance

The document mentions "eVent Medical's bench studies of the Inspiration with high percentages of Helium." However, no specific sample size for a test set (e.g., number of test scenarios, ventilator units tested, or duration of tests) is provided.

The data provenance for the bench studies is internal to eVent Medical ("eVent Medical's bench studies"). It is implied to be prospective testing conducted by the manufacturer for this submission. The document also refers to a "review of the clinical literature on the operation of the Inspiration with Heliox," but this appears to be a separate supporting review rather than a primary study for this specific device modification.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The text refers to "eVent Medical's bench studies," implying internal testing, but does not detail the personnel or expert involvement in establishing ground truth for these tests.

4. Adjudication Method for the Test Set

This information is not provided in the document. Given the context of "bench studies," it's likely internal verification processes were used, but no specific adjudication method (like 2+1/3+1 expert review) is mentioned, as this is typically more relevant for clinical image interpretation or diagnostic device studies.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done; Effect Size

No, an MRMC comparative effectiveness study was not done or at least not described in this document. This type of study is more common for diagnostic imaging AI systems where human readers interpret cases with and without AI assistance. This document describes a continuous ventilator system and its ability to deliver Heliox.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The testing mentioned, "eVent Medical's bench studies," appears to be standalone testing of the device's performance characteristics (e.g., FIO2 accuracy, ability to deliver Heliox without anoxic mixtures). There is no mention of "human-in-the-loop" performance testing for this specific modification, although the overall device is used with human operation.

7. The Type of Ground Truth Used

For the "bench studies," the ground truth would be based on instrumentation and reference measurements of FIO2, gas mixture composition, and potentially other ventilator parameters, established through validated laboratory methods. For the claim that "Heliox poses no increased health risk," the ground truth is derived from a review of clinical literature.

8. The Sample Size for the Training Set

The document describes software modifications and bench studies for a ventilator, not a machine learning or AI-based diagnostic device that typically requires a "training set" in the context of model development. Therefore, the concept of a "training set sample size" as commonly understood in AI/ML is not applicable here and is not provided.

9. How the Ground Truth for the Training Set Was Established

As explained above, there is no training set in the AI/ML sense described here. The "ground truth" for the device's overall design and software development would be established through engineering specifications, regulatory guidelines, and internal validation processes.

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