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The Millennium M10 Oxygen Concentrator is intended to provide supplemental oxygen to persons requiring oxygen therapy. The device is not intended to be life support nor life sustaining.

The Millennium M10 Oxygen Concentrator is a medical device that produces concentrated oxygen from room air for delivery to a patient requiring oxygen therapy. It uses molecular sieve and a pressure swing adsorption process to concentrate oxygen from air. The device is capable of providing oxygen flow up to 10 LPM and is offered with an optional Oxygen Percentage Indicator.

This submission focuses on the substantial equivalence of the Millennium M10 Oxygen Concentrator to existing predicate devices rather than providing a detailed performance study with specific acceptance criteria and ground truth analysis. Therefore, much of the requested information regarding sample sizes, expert qualifications, and specific statistical performance metrics is not available in the provided text.

Here's an analysis based on the available information:

Acceptance Criteria and Reported Device Performance

The document states that "Performance, environmental, electrical, mechanical and electromagnetic compatibility testing was performed to prove the safety and effectiveness of the Millennium M10." However, it does not explicitly list specific numerical acceptance criteria or the reported performance data against those criteria. The conclusion is a general statement of substantial equivalence.

Study Information

Due to the nature of this 510(k) summary, which focuses on substantial equivalence to predicate devices, comprehensive study details typically found in a clinical trial report are not present.

1. Sample size used for the test set and the data provenance: Not explicitly stated. The testing mentioned ("Performance, environmental, electrical, mechanical and electromagnetic compatibility testing") likely involved a series of engineering and bench tests rather than a patient-based test set with a defined sample size for performance evaluation in the context of diagnostic accuracy.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable or not stated. As this is not a diagnostic device with "ground truth" established by human interpretation, there's no mention of experts for ground truth.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable or not stated.
4. 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 an oxygen concentrator, not an AI-assisted diagnostic device.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device, not a standalone AI algorithm. The performance evaluation would be of the device itself.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not explicitly defined as "ground truth" in the diagnostic sense. The "ground truth" for an oxygen concentrator would be its physical output and functional parameters measured against engineering specifications and industry standards for safety and performance (e.g., oxygen concentration, flow rate, purity, noise levels, power consumption, etc.).
7. The sample size for the training set: Not applicable. This is a hardware device, not a machine learning model requiring a training set.
8. How the ground truth for the training set was established: Not applicable.

In conclusion, the provided document is an Abbreviated 510(k) summary for an oxygen concentrator, primarily demonstrating substantial equivalence to existing devices. It outlines that various engineering and performance tests were conducted to confirm safety and effectiveness, but it does not detail specific acceptance criteria or results in the way a diagnostic device study would.

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