(48 days)
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.
§ 868.5440 Portable oxygen generator.
(a)
Identification. A portable oxygen generator is a device that is intended to release oxygen for respiratory therapy by means of either a chemical reaction or physical means (e.g., a molecular sieve).(b)
Classification. Class II (performance standards).