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The LifeChoice Oxygen Concentrator is used on a prescriptive basis by patients who are diagnosed as requiring supplemental 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 LifeChoice Oxygen Concentrator is a prescription use device for patients needing supplemental high concentration oxygen. The LifeChoice is not intended to be life supporting. The device provides approximately 90% oxygen to patients on a demand flow basis at an equivalent rate of 1.0 liter per minute to 5.0 liters per minute in increments of 1.0 liter per minute. The LifeChoice is a portable device which can be used in a home, institution or travel environment. The device uses molecular sieve pressure swing adsorption technology.

This document, specifically a Special 510(k) Summary for the Inova Labs LifeChoice Oxygen Concentrator (Model OXY1000), describes the device and its indications for use, but does not contain information about specific acceptance criteria or a detailed study proving the device meets those criteria, as one would expect for an AI/ML medical device submission.

The document explicitly states: "The technologies used in the modifications to the LifeChoice Oxygen Concentrator do not create any new questions of safety and effectiveness. Benchtop performance testing and comparison of performance characteristics have demonstrated that the modified LifeChoice is substantially equivalent to the previously marketed version."

This indicates that the submission is based on substantial equivalence to a predicate device (K072688) and relies on benchtop testing for performance, rather than a clinical study with human subjects, ground truth establishment, or specific acceptance criteria for AI/ML performance metrics.

Therefore, many of the requested sections about AI/ML specific evaluation are not applicable based on the provided text.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not explicitly stated as pass/fail criteria in the provided document. The basis for acceptance is "substantial equivalence" to a predicate device (K072688).
• Reported Device Performance: The document states the device:
  • Provides approximately 90% oxygen.
  • Delivers oxygen on a demand flow basis at an equivalent rate of 1.0 LPM to 5.0 LPM in increments of 1.0 LPM.

Therefore, a table cannot be constructed as requested for AI/ML performance.

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

• Not applicable. The document refers to "benchtop performance testing" and comparison of characteristics, not a clinical test set with human subjects or data provenance typically associated with AI/ML evaluations.

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)

• Not applicable. This device is an oxygen concentrator, not an AI/ML diagnostic or prognostic system requiring expert-established ground truth for a test set.

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

• Not applicable. No clinical test set or adjudication method is mentioned.

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 not an AI/ML system and no MRMC study was performed.

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

• Not applicable. This is a hardware medical device, not an algorithm.

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

• Not applicable. The performance is based on the physical output of oxygen and flow rates, verified through engineering/benchtop testing, not clinical ground truth like pathology or expert consensus.

8. The sample size for the training set

• Not applicable. This device does not involve a training set as it's not an AI/ML system.

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

• Not applicable. No training set is used for this device.

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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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