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The AMOGS system is intended to provide oxygen enriched gas generated by the pressure swing adsorption process to patients who may have difficulty extracting oxygen from air that they breathe while on board the HH-60M MEDEVAC helicopter. The system may be used to provide medical support to the full spectrum of deployed scenarios including wartime operations, deterrence and contingency operations. peacetime engagement, crisis response and humanitarian relief operations by trained personnel.

The oxygen supplied by the AMOGS is supplemental and is not considered to be life supporting or life sustaining.

This device is not intended to be used in the presence of flammable anesthetics nor is it intended to be sterilized.

There are no contraindications.

The AMOGS system is designed to provide supplemental oxygen meeting USP93% requirements using the Pressure Swing Adsorption (PSA) process on the HH-60M MEV AC helicopter. It is comprised of an oxygen concentrator, monitor panel, backup oxygen cylinder and heat exchanger and filter assembly. The AMOGS utilizes engine bleed air and electrical power from the aircraft resources to provide oxygen-enriched breathing gas for medical evacuation applications. The bleed air is conditioned by the heat exchanger and filter assembly and then routed to the concentrator which produces oxygen-enriched breathing gas. The backup oxygen cylinder provides oxygen-enriched breathing gas during periods in which the concentrator is not operating or the peak demand exceeds the concentrator rated capacity. The monitor panel provides operational status of the concentrator and back up cylinder.

The provided document describes the Aircraft Medical Oxygen Generation System (AMOGS), which is a physical device, not an AI/ML powered medical device. Therefore, the questions related to AI/ML specific criteria such as 'Multi Reader Multi Case (MRMC) comparative effectiveness study', 'standalone (i.e. algorithm only) performance', 'training set sample size', and 'ground truth for training set' are not applicable.

Here's an analysis of the available information based on the device's performance and the study conducted:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: The document does not specify a numerical sample size for the "non-clinical bench and flight testing" or "independent laboratory testing." It mentions "the system" in a singular sense, implying the testing was performed on at least one AMOGS unit.
• Data Provenance: The testing was conducted by "Carleton Life Support Systems, Inc. and the US Army." "Independent laboratory testing" was also performed. This suggests testing was internal to the manufacturer and by a governmental entity (US Army), as well as by an external, unaffiliated lab. The location of these tests (e.g., country) is not specified but is implicitly within the US given the FDA submission. The tests are prospective in nature, as they were conducted to verify performance of the AMOGS device.

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

This question is not directly applicable in the context of a physical oxygen generation system that produces a measurable output (oxygen purity, pressure, contaminants). "Ground truth" here is defined by physical measurements against established standards (USP 93% for oxygen purity, accepted standards for contaminants). The "experts" would be the scientists, engineers, and technicians performing and validating these measurements in the specified test environments. Their qualifications would involve expertise in gas analysis, pressure measurement, and relevant engineering principles, rather than medical interpretation. The document does not specify the number or detailed qualifications of these individuals.

4. Adjudication Method for the Test Set:

Not applicable. Adjudication methods like 2+1 or 3+1 are used in scenarios where human interpretation (e.g., of medical images) requires consensus or resolution of disagreement. For a device producing physical outputs, the "truth" is determined by objective measurement against pre-defined, quantitative standards.

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 versus without AI assistance:

Not applicable. This device is a physical system, not an AI/ML diagnostic tool, and involves no "human readers" or AI assistance in its primary function.

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 physical device. Its performance is inherently "standalone" in the sense that it operates to produce oxygen without human interpretive input for its core function.

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

The ground truth used for performance validation was based on:

• Quantitative Standards: USP 93% for oxygen purity, and "accepted standards" for total gaseous hydrocarbons, halogenated hydrocarbons, and particulates.
• Physical Measurements: Bench and flight testing directly measured the device's output (oxygen purity, pressure) against these quantitative standards.

8. The Sample Size for the Training Set:

Not applicable. There is no "training set" as this is a physical device, not an AI/ML algorithm that learns from data.

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

Not applicable, for the same reason as point 8.

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