(79 days)
The OxLife Oxygen Concentrators are intended to provide supplemental oxygen. The device is not intended for life support nor does it provide any patient monitoring capabilities.
The OxLife Oxygen Concentrators are indicated for the administration of supplemental oxygen.
The OxLife Oxygen Concentrators are prescription devices designed to provide an inexpensive supply of supplemental oxygen in a home, automobile or institution without a continuous source of purfied oxygen. They are not life-supporting nor life-sustaining devices. The devices operate through the use of molecular sieve material that binds with the water and nitrogen in filtered room air to leave a gas that is approximately 93% oxygen when delivered to the patient. The compressor creates a vacuum to suck room air through a pre-filter and HEPA filter into a holding tank. At the same time, downstream of the compressor, the air from the previous cycle is pressurized into one of the two aluminum welded molecular sieve tanks. As the oxygen is forced out of the end of the tank, it enters a 'T' fitting that directs most of the nitrogen out of the second molecular sieve tank into the ambient air. The remaining oxygen is delivered to the patient. On the next cycle, the air is directed into the second molecular sieve tank with the oxygen generated flushing the first tank and continuing the supply to the patient. This repetitive cycle generates the oxygen necessary to flush and prepare the saturated sieve tank while supplying the patient with a continuous flow of high concentration oxygen.
The major change to the device has been the reduction in the size of the molecular sieve tanks and subsequent volume of sieve material. This change allowed the elimination of the crossover valve and required a reduction of the cycle time.
A separate change to be implemented is the addition of an optional, larger inverter capable of operating the 6 LPM models using 12 Volt DC power. Currently, these models are specifically excluded from 12 volt use due to their large power draw.
The provided text describes modifications to an oxygen concentrator and its substantial equivalence to a predicate device. It does not contain information about a study that would involve acceptance criteria, test sets, ground truth, or expert involvement as typically seen in AI/ML device evaluations. The document is a 510(k) summary for a physical medical device, not an AI/ML algorithm.
Therefore, most of the requested information cannot be extracted from the provided text.
However, I can provide the limited information that exists concerning performance and equivalence.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Oxygen output meets specifications | The oxygen output of the modified devices meets specifications. |
| Substantially equivalent to predicate device | Confirmed to be substantially equivalent to the predicate device. |
| Adequate power for 6 LPM models using 12 Volt DC power (with new inverter) | The new inverter provides adequate power to run the larger 6 LPM devices from a 12 Volt DC power source. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The document describes performance testing for a physical oxygen concentrator, not an AI/ML algorithm trained or tested on data.
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)
Not applicable. The "ground truth" here refers to the device's physical performance, not clinical diagnoses or interpretations by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study involving human readers or disagreements requiring adjudication.
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, an MRMC comparative effectiveness study was not done. This document is for a physical medical device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. There is no algorithm described for standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" is based on the physical specifications and performance of the oxygen concentrator, primarily the oxygen concentration output and power capabilities, confirmed through "oxygen concentration testing".
8. The sample size for the training set
Not applicable. There is no mention of a training set as this is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. There is no mention of a training set or its ground truth establishment.
§ 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).