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The Expeditionary Deployable Oxygen Concentration System (EDOCS-120B) is intended to generate and deliver USP grade 93% +/- 3% oxygen for supplemental oxygen use. This device is to be used only by trained personnel in disaster relief situations where bottled oxygen is not readily available.

The Mobile Oxygen Storage Tank (MOST) is intended to store and dispense USP grade 93% (+7%/-3%) oxygen at 50psig nominal pressure for supplemental oxygen use. This device is to be used only by trained personnel in disaster relief situations where bottled oxygen is not readily available.

The Expeditionary Deployable Oxygen Concentration System (EDOCS) is a family of devices that draw in normal air and produce oxygen. The EDOCS separates nitrogen from the air, producing an output of concentrated oxygen at 93 percent by the molecular sieve process. The final product contains not less than 90 percent and not more than 96 percent oxygen, by volume. The remainder of the product consists mostly of argon and nitrogen. EDOCS employs an integral oxygen analyzer to provide control of oxygen purity. The EDOCS device is an electromechanical device consisting primarily of a molecular sieve type oxygen concentrator, a compressor module(s), and one or more oxygen collection cylinders. The oxygen concentrator operates by adsorbing water and nitrogen from filtered air. Depending on the unit size, the resulting gas has increased oxygen at flow rates from 30 to 500 liters per minute at a pressure of 50 - 100 psi nominal and is capable of high pressure cylinder filling.

The Mobile Oxygen Storage Tank (MOST) is a oxygen storage and distribution system consisting of lightweight, high-pressure, composite wound, brass lined cylinders and a distribution manifold secured within a rugged waterproof case. The MOST contains 10,000 liters of oxygen when filled to 2,250 psig (13,400 liters at 3,000 psig). The MOST has a maximum flow capability of 225 LPM, which is equivalent to 75 LPM per Oxygen Output fitting (3 fittings per MOST). These three oxygen output flows would typically be subdivided further by the customer's equipment.

Here's a breakdown of the acceptance criteria and study information for the Expeditionary Deployable Oxygen Concentration System (EDOCS) and Mobile Oxygen Storage Tank (MOST), based on the provided text:

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 the exact sample size for the test sets. It only mentions "Verification and validation testing activities were conducted."
• Data Provenance: The data provenance is not specified. It does not indicate the country of origin or whether the studies were retrospective or prospective.

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

• The document does not mention the use of experts or any process for establishing a "ground truth" in the context of human interpretation or diagnostic accuracy. The testing appears to be focused on device performance against engineering and regulatory standards rather than subjective human assessment.

4. Adjudication Method for the Test Set:

• Not applicable as the testing described is not related to subjective assessments requiring adjudication (e.g., image interpretation). The evaluation is based on objective measurements against predefined technical specifications.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study typically involves human readers evaluating cases with and without AI assistance to assess changes in diagnostic performance. The devices in question (oxygen concentrator and storage tank) are physical medical devices, not diagnostic AI algorithms.

6. Standalone (Algorithm Only) Performance Study:

• Yes, in essence. The performance testing described for both EDOCS and MOST relates to the standalone performance of the devices themselves, without direct human-in-the-loop intervention for the performance evaluation. The devices generate or store oxygen, and their output and characteristics are measured directly against predefined criteria.

7. Type of Ground Truth Used:

• The "ground truth" for the performance testing of these devices is based on objective technical specifications and accepted industry/regulatory standards. These include:
  • USP grade 93% +/- 3% oxygen (United States Pharmacopeia) for purity.
  • US Army specifications (USAMMA) and USAF specifications (AFMESA) for various performance aspects.
  • Voluntary standards.
  • IEC 60601-1-2 for Electrical Safety (Electromagnetic Compatibility).
  • ISO 14971 for Risk Analysis.
  • DOT-CFFC, NASA, and MIL-STD-810F for mechanical and safety aspects.

8. Sample Size for the Training Set:

• Not applicable. These are physical medical devices, not AI algorithms that require a "training set" in the machine learning sense. The devices' operational parameters are set during manufacturing and design, not learned from data.

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

• Not applicable for the reasons stated above.

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