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The Oxygen Concentrator is intended for the administration of supplemental oxygen. This device is not intended for life supporting nor does it provide any patient monitoring capabilities. The system will be operated by trained personnel, at home, in community health care and medical institutions.

The Oxygen Concentrator adopts the principle of pressure swing adsorption technology. At normal temperature, the device can continuously supply a high concentration of supplemental oxygen (93%±3%). The main function of the proposed device includes supplying supplemental oxygen. The device also includes alarms for high temperature, low oxygen output, and interruption of power. The proposed device includes three models, which are M50, M40 and M30. The only difference of the three models is flow rate.

The provided document pertains to a 510(k) premarket notification for an Oxygen Concentrator. As such, it describes a medical device, not an AI/ML algorithm. Therefore, many of the requested details regarding acceptance criteria, study design for AI performance, expert adjudication, and ground truth establishment are not applicable to this document.

The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing and comparison of technical characteristics.

Here's a breakdown of the relevant information from the document, addressing the applicable parts of your request:

1. Table of acceptance criteria and the reported device performance

The document does not present "acceptance criteria" in the typical sense of a target performance metric for an AI algorithm. Instead, it describes compliance with established medical device standards and comparison to a predicate device. The "performance" is demonstrated by meeting these standards and showing similar technical characteristics to the predicate.

Below is a table summarizing the technical characteristics of the proposed device and how they compare to the predicate, which serves as the basis for the substantial equivalence determination. The "acceptance criteria" here are implied by the predicate device's characteristics and relevant standards.

Note on "Acceptance Criteria" for a non-AI/ML device: For this type of device, "acceptance criteria" are typically defined by compliance with recognized standards (e.g., ISO, IEC, AAMI) and demonstration of substantial equivalence to a legally marketed predicate device. The document explicitly states: "Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device."

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

This is not applicable as there is no "test set" in the context of an AI/ML algorithm's performance evaluation. The "testing" refers to non-clinical bench testing to demonstrate compliance with standards and safety/performance specifications of the physical device.

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

This is not applicable. No expert-established ground truth for an AI/ML algorithm's performance is involved in this 510(k) submission.

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

This is not applicable. No expert adjudication for an AI/ML algorithm's performance is involved.

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

This is not applicable. This submission is for a physical medical device (oxygen concentrator), not an AI-assisted diagnostic or therapeutic tool.

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

This is not applicable. There is no algorithm to evaluate in a standalone manner.

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

This is not applicable. For this type of device, "ground truth" relates to the physical and functional parameters of the device (e.g., oxygen purity, flow rate, pressure) as measured by calibrated equipment and verified against engineering specifications and industry standards. It's not a diagnostic or clinical "ground truth."

8. The sample size for the training set

This is not applicable. There is no AI/ML algorithm involved, and thus no training set.

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

This is not applicable. There is no AI/ML algorithm involved, and thus no training set or associated ground truth.

Summary of the Study Proving Device Meets Acceptance Criteria (and Substantial Equivalence):

The "study" refers to non-clinical testing and comparative analysis rather than clinical trials or AI performance evaluations.

• Type of Testing: Non-clinical tests were conducted. These typically include bench testing for electrical safety, electromagnetic compatibility, oxygen concentration accuracy, flow rate stability, alarm functions, sound levels, and biocompatibility of patient-contacting materials.
• Standards Met: The device demonstrated compliance with several international and US standards, including:
  • AAMI / ANSI ES60601-1 (General requirements for basic safety and essential performance of medical electrical equipment)
  • IEC 60601-1-2 (Electromagnetic Compatibility)
  • ISO 80601-2-69 (Particular requirements for basic safety and essential performance of oxygen concentrator equipment)
  • ISO 10993-5 (Biological Evaluation - In Vitro Cytotoxicity)
  • ISO 10993-10 (Biological Evaluation - Irritation and Skin Sensitization)
  • VOCs and PM2.5 test (per EPA TO 15 and IP-10 method)
• Comparison to Predicate Device (K150930): A detailed comparison of technical characteristics (Table 1) was performed against the predicate oxygen generator.
  • Similarities were highlighted in classification, product code, regulation number, intended use principle, and oxygen purity.
  • Differences in flow rate range, sound level, oxygen purity warning threshold, electrical requirements, and outlet pressure were acknowledged and discussed. The submission argues that these differences do not raise different questions of safety and effectiveness because:
    • The proposed device's flow rate is within the predicate's range.
    • Even with a lower oxygen purity warning level (<82% vs <85%), both comply with ISO 80601-2-69.
    • The outlet pressure, while different, also complies with ISO 80601-2-69.
    • Electrical requirements, though different, comply with the relevant electrical safety and EMC standards.
• Conclusion: Based on the non-clinical tests and the comparison, the manufacturer concluded that the proposed device models are substantially equivalent to the predicate device.
• Clinical Study: The document explicitly states: "No clinical study is included in this submission." This indicates that the substantial equivalence determination for this device did not require human clinical data.

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