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The Invacare Flyer (Model XPO100) is intended to be used by patients with respiratory disorders who require supplemental oxygen. It supplies a high concentration of supplemental oxygen and is used with a nasal cannula to channel oxygen from the concentrator to the patient. The Invacare Flyer can be used in a home, institution, vehicle and various mobile environments. The Invacare Flyer does not nor is it intended to sustain or support life.

The Invacare Flyer is used by patients with respiratory disorders who require supplemental oxygen. The device can be used in the home, an institutional environment or in a vehicle or other mobile 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 Invacare Flyer provides oxygen in pulsed demand flow dosages at settings of 1 through 5. The oxygen concentration level of the output gas ranges from 87% to 95.6%.

Standard power options include an AC to DC switching power supply operating from AC power outlet (120 VAC/ 60 Hertz nominal), a DC to DC switching power supply operating from accessory outlets typically found in a mobile vehicle type environment (12 VDC nominal) and an external rechargeable battery.

The Invacare Flyer 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 Invacare Flyer is equivalent to other approved oxygen concentrators. The principles of operation are equivalent to the noted predicate device.

The provided document is a 510(k) summary for the Invacare Flyer, Model XPO100, an oxygen concentrator. It establishes substantial equivalence to a predicate device, the Inogen One Oxygen Concentrator (K032818). This type of regulatory submission focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than performing de novo clinical studies with acceptance criteria in the way one might for a novel AI/ML device.

Therefore, the following information about acceptance criteria and studies (especially those relating to AI/ML device performance) is not applicable in this context. The "study" here is generally a comparison to a predicate and adherence to recognized standards.

Here's an analysis based on the provided text, addressing the points where information is available or noting its N/A status:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device, "acceptance criteria" are not reported as specific performance metrics with thresholds in the way a diagnostic AI might have. Instead, substantial equivalence is demonstrated through comparative features and adherence to recognized standards. The "reported device performance" is implicitly shown by meeting these standards and having comparable features to the predicate.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable. The submission does not detail a "test set" or specific patient data in the context of diagnostic performance. Performance testing refers to engineering and electrical safety standards testing, not clinical studies with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable. There is no "ground truth" establishment in the context of diagnostic accuracy for this device, nor a test set requiring expert adjudication.

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

This is not applicable. No test set or adjudication method is described.

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 is an oxygen concentrator, not an AI-assisted diagnostic device.

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

This is not applicable. This is an oxygen concentrator, not an algorithm-only device. Its operation is standalone in the sense that it produces oxygen, but it doesn't perform diagnostic or interpretive functions that would be evaluated in this manner.

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

This is not applicable. "Ground truth" in the context of medical device performance studies (particularly for AI/ML) is not a concept applied to oxygen concentrators. The device's "truth" is its ability to produce oxygen within specified parameters and operate safely according to engineering standards.

8. The sample size for the training set

This is not applicable. There is no "training set" for an oxygen concentrator. The device's design is based on established engineering principles and technology, not machine learning or data training.

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

This is not applicable. As there is no training set, there is no ground truth for it.

Summary of the "Study" (Demonstration of Substantial Equivalence):

The "study" in this 510(k) submission is primarily a comparative analysis against a legally marketed predicate device (Inogen One Oxygen Concentrator; K032818) and adherence to recognized performance and safety standards.

• Evidence Type: Bench testing, adherence to national and international standards for medical electrical equipment (e.g., ASTM, ISO, UL, IEC standards for electromagnetic compatibility, safety, and oxygen concentrator-specific requirements), and a comparison of technical specifications.
• Key Finding: The Invacare Flyer performs as intended and is substantially equivalent to the predicate device, with differences in physical dimensions and weight determined not to affect safety or effectiveness.
• No specific sample sizes (e.g., patients, images) are mentioned as this is not a clinical performance study in the typical sense for AI/ML.
• Data Provenance (for comparative data): The performance data is derived from direct testing of the Invacare Flyer against engineering standards and comparison of its specifications to the publicly available specifications of the predicate device.
• Experts/Ground Truth/Adjudication: Not applicable in the context of diagnostic performance. The "experts" are likely the engineers and regulatory professionals who conducted the tests and compared the specifications. The "ground truth" is adherence to the scientific and engineering principles embodied in the referenced standards.

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