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The YuYue OxygenMax™ 7F-5 Oxygen Concentrator is intended solely for medical use in oxygen therapy programs under the supervision of a physician. It is intended to provide supplemental oxygen to patients with respiratory disorders for use in the home or health care facility. This device is available by prescription only and is not intended to support or sustain life.

The Yuyue OxygenMax™ 7F-5 oxygen concentrator (" the Yuyue 7F-5") is used by patients with respiratory disorders who require supplemental oxygen. The device can be used in the home or an institutional environment. The device is not intended to sustain or support life. The device is used with a nasal cannula to direct oxygen from the device to the patient. The Yuyue 7F-5 provides oxygen in pulsed demand flow dosages at settings of 1 through 5. The oxygen concentration level of the output gas ranges from 90% to 94%. The Yuyue 7F-5 uses a standard AC power of 120 V/60 Hertz. The Yuyue 7F-5 uses a molecular sieve and pressure swing adsorption methodology to produce the oxygen gas output. Ambient air enters the device, is filtered and then compressed. This compressed air is then directed toward one of two nitrogen adsorbing sieve beds. Concentrated oxygen exits the opposite end of the active sieve bed and is directed into an oxygen reservoir where it is delivered to the patient in specific volumes during the inhalation portion of a detected breath The basic technology of The Yuyue 7F-5 is commonly used and equivalent to other FDA approved oxygen concentrators under the same Product Code of CAW. The principles of operation are equivalent to the predicate device.

The provided text describes a 510(k) premarket notification for a medical device, the Yuyue OxygenMax™ 7F-5 oxygen concentrator. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a de novo study with acceptance criteria and novel performance data. Therefore, many of the requested elements for a study proving acceptance criteria will not be present in this document.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not provide specific acceptance criteria in the format of a table with numerical thresholds for performance metrics. Instead, it relies on demonstrating conformity to recognized standards and substantial equivalence to a predicate device.

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

The document does not describe a test set or data provenance in the context of a clinical study or new performance data. The evaluation is based on bench testing against established standards and comparison to a predicate device. Therefore, there is no "test set" in the traditional sense for evaluating AI or diagnostic performance.

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

Not applicable. This is a 510(k) submission for an oxygen concentrator, not an AI or diagnostic device that relies on expert ground truth for a test set.

4. Adjudication Method for the Test Set

Not applicable. There is no test set requiring adjudication in this submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This device 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 device is an oxygen concentrator, not an algorithm. Bench tests were performed to demonstrate compliance with standards and equivalence to the predicate device.

7. The Type of Ground Truth Used

The "ground truth" in this context is the conformity to established engineering and medical device standards (ISO 8359, ASTM F1464-93, IEC 60601-1-2) and the demonstrated equivalence to a legally marketed predicate device (John Bunn® O2 Premier oxygen concentrator, K844223). This is primarily based on technical specifications, functional testing, and regulatory compliance, rather than clinical outcomes or pathology data for a new diagnostic claim.

8. The Sample Size for the Training Set

Not applicable. This device is an oxygen concentrator, not an AI algorithm requiring a training set.

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

Not applicable. This device is an oxygen concentrator.

Summary of the Study and Device Proof:

The study proving the device meets the acceptance criteria is primarily a non-clinical performance evaluation based on bench testing and a substantial equivalence comparison to a predicate device.

• Bench Tests: The Yuyue 7F-5 underwent bench tests to conform to the following recognized standards:
  • ISO 8359:1996 for oxygen concentrators for medical use - safety requirements.
  • ASTM F1464-93 (2005) for oxygen concentrators for domiciliary use.
  • IEC 60601-1-2:2001 for medical electrical equipment - electromagnetic compatibility.
  • FDA Reviewer Guidance document "Excerpts Related to EMI from November 1993" as appropriate.
• Substantial Equivalence: The Yuyue 7F-5 was determined to be substantially equivalent to the John Bunn® O2 Premier oxygen concentrator (K844223). The submission states that, "Except using different trade name and model name, the subjective device and the predicate device is identical in the intended use, specification and other key characteristics." Minor power supply differences between models were noted but the counterpart models (Yuyue 7F-5 and John Bunn O2 Premier, JB0160-010/015) use identical power supply.

The results of these tests and the successful demonstration of substantial equivalence were deemed sufficient by the FDA to determine that the Yuyue 7F-5 oxygen concentrator is safe and effective for its intended use.

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