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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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The Mobile Oxygen Storage Tank (MOST) is intended to provide 93% oxygen at 50 psig nominal pressure for supplemental oxygen use only. The MOST is intended to be filled from the Expeditionary Deployable Oxygen Concentration System (E-DOCS) only. The MOST is intended for military use only.

The Mobile Oxygen Storage Tank (MOST) is an oxygen storage and distribution system consisting of lightweight, high strength, high-pressure composite wound brass lined cvlinders and a distribution manifold secured within a rugged waterproof case. The MOST contains 10,000 liters of oxygen when filled to 2,250 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).

Acceptance Criteria and Device Performance Study for Mobile Oxygen Storage Tank (MOST)

The Mobile Oxygen Storage Tank (MOST) is an oxygen storage and distribution system consisting of lightweight, high-strength composite wound brass-lined cylinders and a distribution manifold secured within a rugged waterproof case. It is intended to provide 93% oxygen at 50 psig nominal pressure for supplemental oxygen use and is designed to be filled exclusively from the Expeditionary Deployable Oxygen Concentration System (E-DOCS) for military use only.

1. Table of Acceptance Criteria and Reported Device Performance

Overall Conclusion: In all instances, the device met all required performance criteria and functioned as intended, meeting the acceptance criteria.

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

The document does not explicitly state the sample size used for the test set. However, it indicates that "Verification and validation testing activities were conducted to establish the performance, reliability and safety characteristics of the MOST, to demonstrate performance as intended."

The data provenance is not explicitly stated as "retrospective" or "prospective" but implies prospective testing done for regulatory submission (510(k)). The acceptance criteria are based on USAF specifications (AFMESA), DOT-CFFC, NASA, and MIL-STD-810F, which are established standards and likely originate from the United States.

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

The document does not specify the number of experts used or their qualifications for establishing ground truth. The acceptance criteria are derived from established military and governmental specifications (USAF, DOT-CFFC, NASA, MIL-STD-810F), implying that these standards themselves constitute the "ground truth" to which the device's performance was compared.

4. Adjudication Method for the Test Set

The document does not mention an adjudication method for the test set. Given that the testing involved comparing device performance against predefined technical specifications from recognized bodies (USAF, DOT-CFFC, NASA, MIL-STD-810F), the assessment would likely be an objective measurement against these standards rather than a subjective adjudication process involving multiple human experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size

No multi-reader multi-case (MRMC) comparative effectiveness study was done or mentioned. This type of study is typically for diagnostic imaging devices where human interpretation is a key component, which is not the case for an oxygen storage and distribution system like the MOST.

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

The MOST is a physical device, not an algorithm. Therefore, the concept of "standalone performance" in the context of an algorithm does not apply. The testing conducted was focused on the physical performance and safety characteristics of the device itself.

7. The Type of Ground Truth Used

The ground truth used for the testing was based on established technical specifications and standards from various organizations including:

• USAF specifications (AFMESA)
• DOT-CFFC
• NASA
• MIL-STD-810F

These specifications define the required purity, flow rate, mechanical integrity, controls, overall device performance, and safety parameters for such equipment.

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable to this device. The MOST is a physical medical device, not a machine learning model that requires a training set.

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

As explained in point 8, a training set is not applicable to this device. Therefore, no ground truth was established for a training set.

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