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The Oxygen Concentrator is indicated for the delivery of supplemental oxygen in the home or medical institutions. The device is not intended for life support nor does it provide any patient monitoring capabilities.

The Merits Health Products Oxygen Concentrators are prescription devices designed to provide an inexpensive supply of supplemental oxygen in a home or institution without a continuous source of purified oxygen. They are not lifesupporting 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 draw room air 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 gas to flush 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. Other options will include an Oxygen alarm and a pediatric flowmeter.

The provided text is a 510(k) summary for an oxygen concentrator, which is a medical device. This document focuses on demonstrating substantial equivalence to predicate devices and does not describe acceptance criteria, a detailed study proving performance, or specific AI/algorithm performance metrics. The information requested falls outside the scope of this particular submission for a Class II medical device like an oxygen concentrator, which typically relies on established performance standards for its product category rather than complex efficacy studies with AI components.

Therefore, most of the requested information cannot be extracted from the given text.

Here's a breakdown of what can be inferred or directly stated:

1. Table of acceptance criteria and the reported device performance

The document states: "The Device meets the requirements of the FDA recognized standard of the first The Device meets the requirements of the PDF roosgnitations of the predicate devices."

This implies that the acceptance criteria are based on the FDA-recognized standards applicable to oxygen concentrators and that the device's performance met these standards. However, the specific quantitative criteria (e.g., oxygen purity levels, flow rates) and the exact reported performance values are not detailed in this summary. It only indicates compliance.

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/Not provided. This submission is for a physical medical device (oxygen concentrator), not a data-driven AI algorithm. There is no "test set" in the context of diagnostic performance. Performance tests would relate to the physical operation of the concentrator itself (e.g., oxygen output, reliability).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable/Not provided. This information is relevant for studies validating diagnostic algorithms, not for the regulatory submission of an oxygen concentrator.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/Not provided. Similar to point 3, this is for diagnostic studies.

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

Not applicable/Not provided. The device is an oxygen concentrator, not an AI diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable/Not provided. The device is an oxygen concentrator, not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable/Not provided. For an oxygen concentrator, performance "ground truth" would be objective measurements like oxygen concentration, flow rate, noise levels, and durability, measured against established engineering and medical device standards. These specific measurements are not presented in this summary.

8. The sample size for the training set

Not applicable/Not provided. There is no "training set" as this is not an AI/machine learning device.

9. How the ground truth for the training set was established

Not applicable/Not provided. There is no "training set" as this is not an AI/machine learning device.

In summary, the provided document is a 510(k) Pre-Market Notification for an oxygen concentrator. Its purpose is to demonstrate "substantial equivalence" to other legally marketed devices, primarily by showing that it has the same intended use, technological characteristics, and performs according to established FDA-recognized standards for its device class. It does not contain the detailed study results, acceptance criteria, or AI-specific information requested, as these are not typically part of a 510(k) submission for this type of device.

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