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The Oxygen Concentrators are indicated for provide supplemental oxygen when the patient is away from their primary home oxygen source. The devices are not intended for life support nor do they provide any patient monitoring capabilities.

The Merits Health Products Portable Oxygen Concentrator is the prescription device designed to use in an automobile, with power from the automobile's battery and for use with an AC power supply. It is not for 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 90% 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. This submission covers a model that has 1-liters per minute continuous flow output and 2-6 liters per minute for demand flow which is actuated by breathing and detecting oxygen concentration whenever greater than 85%. An oxygen alarm is built in the oxygen concentrator.

The provided text is a 510(k) summary for Merits Health Products Oxygen Concentrators. This document describes the device, its intended use, and claims substantial equivalence to a predicate device. However, it does not contain specific acceptance criteria or a detailed study proving the device meets said criteria in a quantifiable manner typical for studies involving AI/ML devices.

The document generally states: "The results of the testing confirm that the device meets specifications and is substantially equivalent to the predicate device." without elaborating on what those specifications are or what specific tests were performed beyond general performance and design.

Therefore, many of the requested categories cannot be filled from the provided text.

Here's an attempt to extract what information is present and indicate where information is missing:

Acceptance Criteria and Device Performance Study for Merits Health Products Oxygen Concentrator

Based on the provided K053230 510(k) summary, specific acceptance criteria and detailed study results demonstrating the device meets those criteria are not explicitly provided in a quantifiable table format. The document generally states that the device "meets specifications" and is "substantially equivalent to the predicate device."

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: Comprehensive, quantifiable acceptance criteria (e.g., minimum oxygen purity at specific flow rates, alarm activation thresholds, pressure specifications, battery life, etc.) are not detailed in this summary.

2. Sample size used for the test set and the data provenance

• Sample size for test set: Not specified. The document refers to "testing" but does not detail the size or nature of the test subjects or samples.
• Data provenance: Not specified. It can be inferred that testing was conducted by Merits Health Products Co., LTD. (Taiwan) but details on the type of data (e.g., patient data, engineering test data) or its origin are not provided.

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

• This information is not applicable to this type of device and submission. The device is a hardware oxygen concentrator, not an AI/ML-driven diagnostic or prognostic tool that would typically require expert-established ground truth for a test set. The performance would be measured against engineering specifications and industry standards.

4. Adjudication method for the test set

• Not applicable. This is typically relevant for studies involving human interpretation or AI output review against a gold standard. Device performance for an oxygen concentrator is assessed through engineering and functional testing.

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. This is an oxygen concentrator, not an AI-assisted diagnostic tool.

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

• Not applicable. This is a hardware device; there is no "algorithm only" performance to evaluate in this context. The device's function is standalone in its operation to produce oxygen.

7. The type of ground truth used

• Type of ground truth: Implied to be engineering specifications and established performance standards for oxygen concentrators (e.g., oxygen purity measured by analytical equipment, flow rates verified by flow meters). The document indicates "comparison to currently marketed devices" (predicate device: Innosan Travelair "S" Plus Portable Oxygen Concentrator K971947), suggesting the predicate's performance or relevant standards serve as a benchmark.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device that requires a training set.

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

• Not applicable. This is not an AI/ML device that requires ground truth for a training set.

Summary of Study:

The provided document describes a 510(k) submission for an oxygen concentrator. The "study" mentioned is general "testing" to confirm the device meets specifications and is "substantially equivalent" to a predicate device (Innosan Travelair "S" Plus Portable Oxygen Concentrator - K971947). The submission relies on established technologies (molecular sieve material, demand flow delivery systems) and claims that "There are no major technologies differences." The document does not provide a detailed, quantitative study with specific acceptance criteria, sample sizes, or detailed performance metrics. Instead, it makes a high-level assertion of compliance and equivalence.

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