(49 days)
The POGS is intended to provide supplemental oxygen. Device is to be operated by trained medical personnel only for military use only.
The On Site Gas Systems portable oxygen generator is a prescription device designed to provide an inexpensive supply of supplemental oxygen in a military environment without a continuous source of The feed air compressor creates a vacuum to draw air into a oxygen. holding talk. The air is then flushed through two tanks in series to provide continuous oxygen. The molecular sieve material adsorbs nitrogen, which comprises approximately 78% of the makeup of air. The resulting gas is approximately 93% oxygen.
The variations of the device are to allow for less total flow, to accommodate fewer cannulas per device. The variations are designed and tested for same indication of use, safety and effectiveness; variations are substantially equivalent to predicate devices.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Portable Oxygen Generator:
This submission is a 510(k) premarket notification for a Class II medical device (Portable Oxygen Generator). The document focuses on demonstrating substantial equivalence to previously marketed devices rather than presenting a novel clinical study with detailed performance metrics against specific acceptance criteria.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| ASTM F 1464-93 Compliance | The device meets the requirements of the FDA recognized standard covering Oxygen Concentrators, ASTM F 1464-93. |
| Substantial Equivalence | The device is substantially equivalent to legally marketed predicate devices (On Site Gas Systems Portable Oxygen Generation System K 020362 and K 014078). |
| Indication for Use | To provide supplemental oxygen, operated by trained medical personnel for military use only. (Device designed and tested for same indication of use, safety and effectiveness as predicate devices). |
| Oxygen Concentration | Produces approximately 93% oxygen (This is a description of the technology, not explicitly an acceptance criterion, but implied by the device's function). |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not explicitly state a sample size for a test set or data provenance in the context of a clinical study. The performance data section refers to compliance with an industry standard and substantial equivalence to predicate devices, implying that testing was conducted to demonstrate these points, but the details of such testing (e.g., number of devices tested, duration of testing) are not provided.
3. 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)
This information is not applicable and not provided in the document. This submission does not describe a study involving expert review or ground truth establishment in the way typically seen for diagnostic AI/imaging devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided. No adjudication method is mentioned as there's no clinical trial with expert review described.
5. 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
No MRMC comparative effectiveness study was done or described. This device is an oxygen generator, not a diagnostic imaging device with AI assistance for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable and not provided. The device is an oxygen generator, not an algorithm. Its "performance" refers to its ability to mechanically produce oxygen meeting specified purity and flow, not algorithmic performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The concept of "ground truth" as typically used in AI/diagnostic studies is not applicable here. The performance is assessed against engineering and performance specifications outlined in the ASTM F 1464-93 standard and by comparison to the functionality of predicate devices. The "truth" is whether the device consistently produces oxygen of a certain purity and flow rate under various conditions as required by the standard.
8. The sample size for the training set
This information is not applicable and not provided. This is not a machine learning or AI device, so there is no "training set."
9. How the ground truth for the training set was established
This information is not applicable and not provided. As there is no training set, there is no need to establish ground truth for one.
Summary of the Study and Device Proof:
The "study" or proof for this device meeting its acceptance criteria is based entirely on its compliance with the FDA recognized standard ASTM F 1464-93 and demonstrating substantial equivalence to two legally marketed predicate devices (K 020362 and K 014078). The manufacturer states that the device "meets the requirements" of this standard. This implies that engineering tests, design verification, and validation activities were performed against the specifications within that standard. The effectiveness is also tied to the fact that "variations are designed and tested for same indication of use, safety and effectiveness" as the predicate devices. The core technology, molecular sieve material for oxygen concentration, is stated to be "well established" and used in the predicate devices.
This 510(k) submission is a declaration of compliance and equivalence, rather than a detailed report of a clinical efficacy trial. Specific data points from tests demonstrating compliance to ASTM F 1464-93, such as oxygen concentration levels over time, flow rates, alarm functionality, and environmental tolerances, would have been submitted to the FDA, but they are not detailed in this summary document.
§ 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).