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The LifeChoice Oxygen Concentrator is used on a prescriptive basis by patients who are diagnosed as requiring supplemental oxygen. This oxygen concentrator will provide supplemental, high concentration oxygen to these patients. It is not life supporting nor life sustaining. It may be used continuously in a home, institution or travel environment. The LifeChoice is also portable.

The IBC LifeChoice Oxygen Concentrator is a prescription use device for patients needing supplemental high concentration oxygen. The LifeChoice is not intended to be life sustaining or to be life supporting. The LifeChoice provides approximately 90% oxygen to the patients on a demand flow basis at an equivalent rate of 1.0 liter per minute to 3.0 liters per minute in increments of 1.0 liter per minute. The LifeChoice is a portable device which may be used continuously in a home, institution or travel environment. The LifeChoice uses molecular sieve pressure swing adsorption technology.

The provided text describes a 510(k) submission for the International Biophysics Corporation (IBC) LifeChoice Oxygen Concentrator. This is a medical device submission, and as such, the "acceptance criteria" and "device performance" are typically defined by demonstrating substantial equivalence to a predicate device, rather than explicit numerical performance metrics like those for an AI algorithm.

Here's an analysis based on the provided text, addressing your points where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device (portable oxygen concentrator), "acceptance criteria" are generally based on meeting the performance characteristics of an already legally marketed predicate device. The text does not provide a specific table of numerical acceptance criteria or detailed performance metrics. Instead, it relies on a qualitative comparison.

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

The text does not provide information about a "test set" in the context of an algorithmic evaluation. This is a medical device submission for a physical oxygen concentrator, not an AI algorithm. The evaluation relies on "Benchtop performance testing" and comparison to a predicate device. Therefore, concepts like sample size for a test set, country of origin, or retrospective/prospective data are not applicable in the way they would be for an AI study.

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

This information is not applicable as there is no "test set" or "ground truth" to be established by experts in the context of an AI algorithm evaluation. The device's "truth" is its physical performance and adherence to established engineering principles, benchmarked against a predicate.

4. Adjudication Method

This information is not applicable for the same reasons as above. There's no expert adjudication of image or data interpretation.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This type of study is relevant for evaluating the impact of an AI system on human reader performance (e.g., radiologists interpreting images). The IBC LifeChoice Oxygen Concentrator is a physical device, not an AI algorithm, so an MRMC study was not conducted.

6. Standalone Performance Study

Yes, in a sense. The text mentions "Benchtop performance testing" for the IBC LifeChoice. This would be considered the standalone performance evaluation for the physical device itself (i.e., how it performs in terms of oxygen concentration, flow rate, power consumption, etc., without human interaction during its operation). However, the specific results of this testing are not detailed in the provided summary, only that it demonstrated substantial equivalence.

7. Type of Ground Truth Used

The "ground truth" for this medical device's performance is ultimately derived from:

• Its engineering specifications and physical measurements (e.g., actual oxygen concentration produced, flow rates, battery life).
• The performance characteristics of the predicate device (AirSep LifeStyle Oxygen Concentrator), which serves as the established benchmark for safety and effectiveness.
• Adherence to recognized standards and regulations for oxygen concentrators.

8. Sample Size for the Training Set

This information is not applicable. The IBC LifeChoice is a physical device using established technology (molecular sieve pressure swing adsorption). It does not involve machine learning or AI that would require a "training set."

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

This information is not applicable as there is no training set for an AI algorithm.

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