(215 days)
The emOx™ device by MedTrak is intended to generate 99% pure oxygen for emergency first aid administration.
The emOx™ device is a lightweight, portable device that produces oxygen of greater than 99% purity by a chemical reaction. The evolved oxygen bubbles pass through a water-filled chamber to humidify the gas on its way to the patient via flexible, ribbed tubing and an open adult or pediatric face mask.
The device, other than the face mask, does not come into contact with the patient. The mask is a currently legally marketed adult or pediatric mask. The oxygen container is constructed of polypropylene. Therefore, the biocompatibility of the materials used is without significance.
This request pertains to the acceptance criteria and supporting studies for a medical device described in a 510(k) premarket notification, not an AI/ML powered device that relies on algorithms and ground truth data. Therefore, many of the questions regarding AI/ML specific details (e.g., sample sizes for training/test sets, expert adjudication, MRMC studies, ground truth establishment for training) are not applicable to this document.
However, I can extract the relevant information from the provided text regarding the device's acceptance criteria and the tests performed.
Acceptance Criteria and Reported Device Performance for MedTrak International Inc: emOx™
| Acceptance Criteria | Reported Device Performance / Test Conclusion |
|---|---|
| Oxygen Purity | Greater than 99% purity (Stated in device description and comparable predicate device, confirmed by independent lab testing) |
| Minimum Oxygen Volume | Minimum of 60 liters (Stated as comparable to predicate device) |
| Minimum Mean Flow Rate | 4.0 L/min or greater (Stated as comparable to predicate device, confirmed as 4.6 L/min by independent lab testing) |
| Contaminants (specifically CO or CO2) | No detectable CO or CO2 (Confirmed by independent lab testing) |
| Toxicity | Non-toxic (Confirmed by independent lab testing) |
| Fire or Explosion Hazard | No fire or explosion hazard (Confirmed by independent lab testing) |
| Stability | Confirmed by independent lab testing (No specific performance metric given, implies stability was met) |
| Decomposition Products | Confirmed by independent lab testing regarding acceptability (No specific performance metric given, implies acceptable levels) |
Study Details:
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- The document does not specify a "test set" in the context of data for an algorithm. Instead, it refers to non-clinical tests performed by independent laboratories on the device itself. Therefore, sample sizes for these tests are not provided, nor is the provenance of "data" in the sense of clinical data. It describes physical testing of the device.
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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 not an AI/ML algorithm that requires expert-established ground truth from a dataset. The "ground truth" here is the physical measurement of the device's output (e.g., purity, flow rate) by independent testing laboratories.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable for a physical device test. The tests were performed by "independent test laboratories," implying standard scientific measurement and reporting, not expert adjudication of cases.
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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-powered device. No clinical tests were performed as explicitly stated in the document.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI/ML algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this device's performance is based on direct physical and chemical analytical measurements performed by independent test laboratories (e.g., gas chromatography for purity, flow meters for flow rate, analytical chemistry for contaminants).
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The sample size for the training set:
- Not applicable. This is not an AI/ML algorithm that requires a training set.
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How the ground truth for the training set was established:
- Not applicable. This is not an AI/ML algorithm that requires a training set.
§ 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).