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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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