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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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The DOGS-M system is intended to provide supplemental oxygen enriched gas to patients who may have difficulty extracting oxygen from air that they breathe. 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 military personnel.

The DOGS-M has the capability to supply pressurized oxygen to fill gas cylinders that can be transported to remote locations away from the DOGS-M system or to fill cylinders for patient ambulatory use.

The oxygen supplied by the DOGS-M 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 Deployable Oxygen Generation System – Medium (DOGS-M) is a point of use oxygen generation system designed to meet the needs of the Air Force for ground based medical support. The DOGS-M consists of an oxygen generation system, a low pressure oxygen compressor, high pressure oxygen compressor, cylinder evacuation pump and integral back up oxygen storage cylinders in a single module. The oxygen generation system uses an integral air compressor and Pressure Swing Adsorption (PSA) technology to separate up to 120 liters per minute of oxygen meeting the requirements of USP93% from ambient air. The high pressure compressor is designed to charge cylinders to 2250 psig at approximately 60 liters per minute. To insure that there are no contaminants in the cylinders prior to filling, the system is provided with an evacuation pump that can evacuate an H cylinder down to 25 inches mercury in less than 10 minutes.

Here's an analysis of the provided text regarding the Deployable Oxygen Generation System - Medium (DOGS-M), structured to address your specific questions about acceptance criteria and the supporting study:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided text does not specify a sample size for any test set or the data provenance (e.g., country of origin, retrospective/prospective). The performance claims are stated generally as capabilities verified through testing.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not mentioned in the document. The testing described appears to be technical bench testing of the device's physical and chemical output, rather than a clinical study requiring expert assessment of patient outcomes or imagery.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not mentioned in the document. Adjudication methods are typically used in clinical trials where there's a need to resolve discrepancies in expert opinions, which isn't relevant for the type of technical performance testing described.

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

An MRMC comparative effectiveness study was not performed and is not applicable to this device. This type of study is relevant for diagnostic devices where human readers interpret medical images or data, and the AI's impact on their performance is being evaluated. The DOGS-M is an oxygen generation system, not a diagnostic tool.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, a standalone study was performed in the sense that the device's technical capabilities were tested independently. The performance section states: "Non-clinical bench testing by Carleton Life Support Systems, Inc. verified that the system is capable of producing... Independent laboratory testing also verified that oxygen purity was in accordance with USP 93% and that total gaseous hydrocarbons and halogenated hydrocarbons and particulates were below accepted standards." This indicates the device's performance was assessed directly, without human interaction in a clinical setting to interpret its output in relation to patient care.

7. The Type of Ground Truth Used

The ground truth used for this device's performance assessment was based on objective, measurable criteria and established standards. Specifically:

• USP 93%: United States Pharmacopeia standards for oxygen purity.
• Pressures: Engineering specifications for psig (pounds per square inch gauge) and inches mercury.
• Flow Rates: Engineering specifications for liters per minute (lpm).
• Contaminant Standards: "Accepted standards" for total gaseous hydrocarbons, halogenated hydrocarbons, and particulates (though the specific standards are not cited, they would be objective, scientific measurements).

8. The Sample Size for the Training Set

This information is not mentioned and is not applicable. The DOGS-M is a physical medical device (an oxygen concentrator) and does not involve AI or machine learning algorithms that require a "training set" in the computational sense.

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

This information is not mentioned and is not applicable for the reasons stated above (no AI/ML training set).

Summary of the Study Proving Acceptance Criteria:

The study described is primarily non-clinical bench testing and independent laboratory testing. This testing was conducted by Carleton Life Support Systems, Inc. (the applicant) and an unnamed independent laboratory. The purpose was to verify the technical specifications and output quality of the DOGS-M against predefined engineering and regulatory standards (like USP 93%). The testing demonstrated that the device could produce the specified volume and purity of oxygen, charge cylinders to the required pressures, and meet contaminant limits. The absence of details regarding sample sizes for testing or expert involvement is typical for this type of technical device clearance, where the focus is on objective physical and chemical performance. The clearance was granted based on substantial equivalence to a predicate device (DOCS), indicating that the validated performance was considered comparable and raised no new questions of safety and effectiveness.

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The PVOCS HF system is intended to provide respiratory gases to include pre and post operative respiratory oxygen, pneumatic drive gas for ventilators and anesthesia machines, and oxygen enrichment for ventilators and anesthesia machines. It may be used in military field hospitals and other applications where oxygen stored in high pressure cylinders or liquid oxygen is not available, practical or safe to use. It is appropriate for use by military personnel only.

The PVOCS HF is a dual-mode medical gas system which supplies both oxygen-enriched gas at 93 ± 3% oxygen (hereafter referred to as OXY 93% or USP Oxygen 93%) and medical-grade air (MED AIR). In the High Flow OXY 93% mode, the PVOCS HF can supply up to 30 lpm of oxygen and 30 lpm of medical-grade air, and in the Low Flow OXY 93% mode oxygen mode, up to 20 lpm of oxygen and 75 lpm of medical-grade air. The system requires a separate compressed air supply from which oxygen is concentrated using pressure swing adsorption (PSA) techniques with synthetic zeolite. The oxygen is supplied at two low-pressure (6-psig) ports for patient respiration via nasal cannula and four moderate-pressure (50-psig) ports for patient ventilators. A storage plenum (purge tank) is included in the product line to ensure that short-term, high-demand flows do not cause a drop in oxygen concentration or pressure drops below rated output pressure in the product gas. The medical-grade air is provided to four ports at 50 psig by filtering the compressed air supply and drying it using PSA techniques.

This document describes the Patient Ventilation Oxygen Concentrating System, High Flow (PVOCS HF). However, it does not contain a study section with acceptance criteria and device performance in the format requested. The provided text is a 510(k) premarket notification for a medical device and typically focuses on demonstrating substantial equivalence to a predicate device through non-clinical bench testing rather than detailed clinical trial results with specific acceptance criteria as might be found in a later-stage study.

Based on the provided text, here's what can be extracted and what cannot:

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

The document mentions performance benchmarks but these are stated as capabilities rather than formal acceptance criteria. No explicit "acceptance criteria" are defined.

• Up to 30 lpm of USP 93% oxygen
• Up to 30 lpm of medical grade air |
  | Not explicitly stated in the document | Low Flow OXY 93% mode:
• Up to 20 lpm of USP 93% oxygen
• Up to 75 lpm of medical grade air |
  | Not explicitly stated in the document | Oxygen concentration: 93 ± 3% oxygen |
  | Not explicitly stated in the document | Oxygen port pressure: 6-psig (low-pressure) or 50-psig (moderate-pressure) |
  | Not explicitly stated in the document | Medical-grade air port pressure: 50 psig |

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

• Sample size: Not applicable. The "study" mentioned is "Non-clinical bench testing," which typically involves evaluating the physical device's output and specifications, not a patient-related test set.
• Data provenance: "Non-clinical bench testing by Carleton Life Support Systems, Inc." Implies internal company testing, likely in their facilities (Davenport, IA, USA would be the most likely location).
• Retrospective or prospective: Not applicable for bench testing.

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. This was non-clinical bench testing assessing physical and chemical properties (oxygen concentration, flow rates, pressure), not a study requiring expert interpretation of medical data or images.

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

Not applicable. This was non-clinical bench testing.

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 a medical device (oxygen concentrator), not an AI-powered diagnostic tool. Therefore, an MRMC study is not relevant or mentioned.

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

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

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

The "ground truth" for non-clinical bench testing would be established engineering specifications, chemical analysis standards, and measurement protocols for parameters like oxygen concentration, flow rate, and pressure. These are not derived from expert consensus, pathology, or outcomes data in the medical sense.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/machine learning algorithm.

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

Not applicable. This is a physical medical device, not an AI/machine learning algorithm.

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