(30 days)
Provides supplemental therapeutic oxygen to a patient in a military field hospital setting.
The Portable Therapeutic Oxygen Concentration System (PTOCS) has been designed to accommodate Military Personnel with a source of supplemental oxygen in a setting where liguid oxygen may be unavailable. Aeromedical Evacuation and ground based medical missions require medical support systems capable of providing therapeutic oxygen. The gaseous oxygen generator will also be required to provide oxygen at the prescribed flow rates and pressures required to operate the oxygen driven equipment included in the AFMS deployable medical assemblages. Requirements are based on the deployable oxygen system, operational requirements document that has been issued by the United States Air Force.
This system is based on the Pressure Swing Adsorption principle and uses a molecular sieve to separate gases from the filtered ambient air. The oxygen is stored and delivered to the patient(s) through one of three ports (1/2 to 15 lpm settings) with a maximum litre per minute flow of 45 total at 50 psig. The oxygen concentration purity level is at 93% minimum, with an oxygen purity level average of 95%. Included with the generator is a secured accessory kit consisting of 20 feet of medical grade oxygen hose and flow regulators for each outlet.
The provided text is a 510(k) summary for the Portable Therapeutic Oxygen Concentration System (PTOCS). This document focuses on establishing substantial equivalence to predicate devices based on non-clinical bench testing, rather than detailed clinical study data with acceptance criteria for a new AI/software device.
Therefore, many of the requested categories for AI/software device studies are not applicable to this submission. The submission is for a physical medical device (an oxygen concentrator) and relies on bench testing to demonstrate performance, not a study evaluating an algorithm's diagnostic performance against a ground truth with human readers.
Here's a breakdown of the information that can be extracted from the document based on your request, with a clear indication of what is not applicable:
Acceptance Criteria and Device Performance
The document states that the PTOCS has an "oxygen concentration purity level is at 93% minimum, with an oxygen purity level average of 95%." This can be inferred as a key performance criterion for the device.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Oxygen concentration purity level: 93% minimum | Oxygen concentration purity level: 93% minimum, with an oxygen purity level average of 95% |
| Flow rates and pressures for oxygen-driven equipment | Capable of providing oxygen at prescribed flow rates and pressures required to operate oxygen driven equipment in AFMS deployable medical assemblages. |
| Maximum flow capacity | 45 total lpm at 50 psig |
| Flow rate settings | 1/2 to 15 lpm settings (through three ports) |
Study Information (as applicable to this type of device submission)
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not explicitly stated as a "test set" in the context of an AI/software study. The testing was "non-clinical bench testing," which implies testing of device units. The number of units tested is not specified.
- Data Provenance: The bench testing was "conducted by Essex Cryogenics of MO., Inc." This indicates the testing was performed internally by the manufacturer in the USA. It is prospective testing of the manufactured device.
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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 is a physical medical device submission, not an AI/software diagnostic device. Ground truth in this context would likely refer to calibrated measurement equipment used in bench testing, not expert consensus on diagnostic images.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. As above, this is for a physical device, and the testing described is non-clinical bench testing, not a clinical study involving human readers or expert adjudication.
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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:
- Not Applicable. This is not an AI-assisted diagnostic device. No MRMC study was conducted.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable. This is not an algorithm-only device. The device itself (the oxygen concentrator) is the standalone entity. Its performance was evaluated through non-clinical bench testing.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the device's performance (e.g., oxygen purity, flow rates) would be established by calibrated measurement instruments in a laboratory setting during "non-clinical bench testing." The document does not provide details on the specific gold standard instruments used, but this is the typical "ground truth" for such physical device testing.
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The sample size for the training set:
- Not Applicable. This is a physical device, not an AI/software device that requires a training set.
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How the ground truth for the training set was established:
- Not Applicable. No training set for an AI/software device is mentioned.
Conclusion from the Document:
The 510(k) summary states: "Non-clinical bench testing conducted by Essex Cryogenics of MO., Inc. as provided is conclusive in establishing substantial equivalence of the PTOCS to the predicate devices on which SE is claimed." This indicates that the performance criteria listed above (oxygen purity, flow rates, pressure) were met during the bench testing, allowing the device to be deemed substantially equivalent to existing predicate oxygen concentrators.
§ 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).