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The Portable Oxygen Generator (POG) is intended to produce oxygen for emergency use at 6 lpm for at least 15 minutes.

The Molecular Products' POG is a chemical based portable oxygen generator which generates 99% oxygen for 15 minutes at a flow rate of 6 lpm. It is a self-contained device with the oxygen delivered via a standard oxygen face mask or nasal cannula.

The document describes the acceptance criteria and performance of the POG (Portable Oxygen Generator) device.

1. Table of Acceptance Criteria and Reported Device Performance

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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.

The variations of the device are to allow for greater total flow, to accommodate more cannulas per device. The variations are designed and tested for same indication of use, safety and effectiveness; variations are substantially equivalent to predicate devices.

The provided text describes a Portable Oxygen Generator (P.O.G.S. - 3.3) by On Site Gas Systems. The submission is a 510(k) premarket notification, indicating a claim of substantial equivalence to previously marketed devices.

Here's an analysis of the acceptance criteria and the study that indicates the device meets them, based only on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

The document refers to "non-clinical tests" and states the device "meets the requirements" of the standard. However, it does not provide any specific sample size for the test set or information regarding data provenance (e.g., country of origin, retrospective/prospective). The testing appears to be centered on compliance with a technical standard rather than a clinical study with patients.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

The document makes no mention of experts being used to establish ground truth for testing. The evaluation of the device's performance is against the technical requirements of ASTM F 1464-93.

4. Adjudication Method for the Test Set:

There is no mention of an adjudication method in the context of the testing described. The assessment is against the parameters of the ASTM standard.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document is for a Portable Oxygen Generator, which is a physical device, and not a diagnostic or imaging algorithm that would typically involve human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

This question is not applicable as the device is a Portable Oxygen Generator, not an algorithm. The assessment is of the device's physical performance.

7. The Type of Ground Truth Used:

The "ground truth" used for this device's acceptance is compliance with the technical specifications and performance requirements outlined in the FDA recognized standard ASTM F 1464-93 for Oxygen Concentrators. This standard defines objective, measurable parameters for oxygen concentration, flow rate, and other safety/performance aspects of such devices.

8. The Sample Size for the Training Set:

This question is not applicable to a physical medical device like an oxygen generator. The concept of a "training set" is relevant for machine learning algorithms, not for the engineering design and testing of a hardware product.

9. How the Ground Truth for the Training Set Was Established:

This question is not applicable, as there is no "training set" for this type of device.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study proving the device meets its acceptance criteria is a "Discussion of Non-clinical Test to Support Determination of Substantial Equivalency" specifically focused on "Performance Data."

The key statement is: "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."

This indicates that:

• The device was subjected to non-clinical tests.
• These tests evaluated its performance against the technical specifications and requirements of ASTM F 1464-93.
• Successful completion of these tests, demonstrating compliance with the standard, served as the basis for the FDA's determination of substantial equivalence.

The document does not provide details of the granular test results, the specific number of units tested, the methodology of how "meeting" the standard was confirmed, or any clinical trial data with human subjects. The acceptance is based on adherence to an established engineering and performance standard.

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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:

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.

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