(619 days)
The OX-GEN Rigid O2 Generation System, Model 5-OX-03 is intended to produce instant, non-pressurized oxygen for emergency uses.
The OX-GEN Rigid O2 Generation System, Model 5-OX-03 is found to be substantially equivalent in that it produces a minimum of 6 liters per minute of 99% pure oxygen for a 15 minute interval, by means of a chemical reaction. The OX-GEN Rigid O2 Generation System is composed of three self-contained chambers that when opened are activated and begin to generate instant, non-pressurized oxygen. The second part of the device consists of the plastic tubing, an inline filter and an oxygen mask, which are attached to the outlet of the oxygen generator.
The provided text describes a 510(k) premarket notification for the OX-GEN Rigid O2 Generation System, Model 5-OX-03. This is a medical device submission seeking clearance based on substantial equivalence to existing devices, not a study directly proving performance against acceptance criteria in the way a clinical trial for a novel drug or a new AI algorithm would.
Therefore, many of the requested categories (expert ground truth, sample sizes, MRMC studies, standalone performance of an algorithm) are not applicable to this type of submission. This submission focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than proving performance against pre-defined quantitative acceptance criteria through a clinical study.
However, we can infer "acceptance criteria" from the performance characteristics of the predicate devices and the new device. The "study" here is essentially the technical comparison and testing performed by the manufacturer to demonstrate these performance characteristics are met.
Here's an attempt to answer the questions based on the provided text, acknowledging the limitations inherent in a 510(k) submission:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred from Predicate/Device Description) | Reported Device Performance (OX-GEN Rigid O2 Generation System, Model 5-OX-03) |
|---|---|
| Minimum oxygen production: 6 liters per minute (LPM) | At least 6 LPM |
| Oxygen Purity: 99% pure oxygen | 99% pure oxygen |
| Duration of oxygen production: 15 minutes | Maintained for at least 15 minutes |
| Maximum temperature of oxygen at the mask | 33°C |
| Intended for emergency uses | Intended to produce instant, non-pressurized oxygen for emergency uses |
| Oxygen generation initiated by chemical reaction | Oxygen generated by a chemical reaction |
| Provided in kit form with necessary components | Provided in kit form with necessary components |
| Single-use device | Designed for single use only |
| Content non-toxic hazard upon disposal | Contents are not a toxic hazard (water, sodium carbonate, manganese dioxide, platinum) |
| Chemicals contain water, 6.0% hydrogen peroxide, manganese dioxide, platinum powder, and sodium percarbonate | Device uses these chemicals |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" sample size in the context of a clinical study or data-driven algorithm validation. Instead, the submission describes the device's technical specifications and performance characteristics, likely derived from laboratory testing and engineering assessments of the physical device.
- Sample Size: Not specified in terms of "test set" for a clinical study. It would refer to the number of devices tested during manufacturing and quality control.
- Data Provenance: Not explicitly stated, but implies prospective engineering and performance testing carried out by the manufacturer (OX-GEN Corporation) in the US.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a medical device submission based on substantial equivalence, not an AI or diagnostic device that requires expert-established ground truth for a clinical dataset. The "ground truth" here is the physical and chemical properties of oxygen generation measured by instrumentation.
4. Adjudication method for the test set
Not applicable. There was no "test set" requiring adjudication by human experts in the context of this submission. Device performance parameters (flow rate, purity, temperature) are objectively measured.
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 device is a portable oxygen generator, not a diagnostic imaging or AI-assisted diagnostic tool. Therefore, MRMC studies and the concept of human readers improving with AI assistance are irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical product, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance would be objective, quantitative measurements obtained through laboratory testing of the oxygen generated. This would involve:
- Gas analyzers to measure oxygen purity.
- Flow meters to measure oxygen flow rate.
- Timers to measure duration of generation.
- Thermometers to measure temperature at the mask.
- Chemical analysis to confirm composition of reactants and products.
8. The sample size for the training set
Not applicable. This device does not involve a "training set" in the context of machine learning or AI algorithms.
9. How the ground truth for the training set was established
Not applicable. As there is no training set, the concept of establishing ground truth for it does not apply.
§ 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).