(39 days)
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
| Acceptance Criteria Category | Acceptance Criteria (Based on) | Reported Device Performance |
|---|---|---|
| Purity | USAF specifications (AFMESA) | Met all required criteria |
| Flow Rate | USAF specifications (AFMESA) | Met all required criteria |
| Mechanical | USAF specifications (AFMESA), DOT-CFFC, NASA, MIL-STD-810F | Met all required criteria |
| Controls | USAF specifications (AFMESA) | Met all required criteria |
| Device Performance | USAF specifications (AFMESA) | Met all required criteria |
| Safety | USAF specifications (AFMESA), DOT-CFFC, NASA, MIL-STD-810F | Met all required criteria |
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.
§ 868.5440 Portable oxygen generator.
(a)
Identification. A portable oxygen generator is a device that is intended to release oxygen for respiratory therapy by means of either a chemical reaction or physical means (e.g., a molecular sieve).(b)
Classification. Class II (performance standards).