(28 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 oxvaen. 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.
This appears to be a 510(k) summary for a medical device, specifically an Oxygen Concentrator (Portable Oxygen Generator). The provided text focuses on the device's description, intended use, and substantial equivalence to predicate devices, rather than a clinical study with detailed acceptance criteria and performance metrics.
Therefore, it's not possible to fully answer all aspects of your request as the provided text does not contain information about a clinical study involving human readers, sample sizes for test/training sets, expert qualifications, adjudication methods, or specific device performance numbers beyond meeting a recognized standard.
However, I can extract the information that is present:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Oxygen Concentration (Minimum) | Approximately 93% oxygen |
| Material Adsorption | Uses molecular sieve material to adsorb nitrogen |
| Continuous Oxygen Provision | Flushes air through two tanks in series to provide continuous oxygen |
| Recognized Standard Compliance | Meets the requirements of ASTM F 1464-93 |
Explanation: The document states that the resulting gas is "approximately 93% oxygen." This can be considered a key performance metric. The main "acceptance criterion" mentioned is compliance with the ASTM F 1464-93 standard for Oxygen Concentrators. The document explicitly states, "The device meets the requirements of the FDA recognized standard covering Oxygen Concentrators, ASTM F 1464-93, and is substantially equivalent to the predicate devices."
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not applicable. The document describes a non-clinical test to support substantial equivalence. It does not mention a "test set" in the context of diagnostic performance or human reader studies.
- Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable. The "test" mentioned is compliance with a standard, not data from a clinical trial.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. There's no mention of experts establishing ground truth for a diagnostic test set in this 510(k) summary. The ground truth for the device's performance would be derived from the physical and chemical testing against the ASTM standard.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No adjudication method is mentioned as there's no interpretation of diagnostic outputs by experts.
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. This is a 510(k) for an oxygen generator, not an AI-powered diagnostic device. Therefore, no MRMC study or AI assistance is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is not an algorithm. Its performance is inherent in its mechanical and chemical operation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this device's performance is objective measurement against the physical and chemical specifications outlined in the ASTM F 1464-93 standard for Oxygen Concentrators, and the measured oxygen concentration (approx. 93%).
8. The sample size for the training set:
- Not applicable. This device is not an AI model that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. No training set is involved.
Summary of what the document does provide regarding acceptance criteria and study:
The primary "study" referred to is a non-clinical test demonstrating compliance with a recognized industry standard: ASTM F 1464-93.
- Acceptance Criteria (implicit): Meeting the specifications set forth in ASTM F 1464-93 for Oxygen Concentrators, and achieving an oxygen concentration of approximately 93%.
- Study: A non-clinical test was performed to verify the device's adherence to the ASTM F 1464-93 standard. The nature of this test (e.g., how many units tested, specific methodologies) is not detailed in this summary, but the conclusion is that it met the requirements.
- Conclusion: The device was deemed "substantially equivalent" to predicate devices based on its design, performance specifications, and intended use, primarily due to its compliance with ASTM F 1464-93.
§ 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).