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Intended to produce oxygen for emergency use at 6 LPM flow rate for at least 15 minutes (90 liters) for individuals 17 years and older requiring emergency or supplemental oxygen.

The Rugged Oxygen Generator (ROG) is intended for environment such as emergency use, home use, and commercial use and is OTC. The ROG is designed to provide supplemental oxygen and is a single use product. The ROG is a chemical oxygen generator that produces a minimum of 90 liters of oxygen at ≥96% purity for minimum of 15 minutes with an average flow rate of 6 liters per minute or greater. There is a need for oxygen in a variety of applications/locations where compressed oxygen cylinders are not suitable.

Principle of Operation: The subject device is initiated though a friction interaction between an integrated phosphorous match and the candle block. To initiate, open the lid and turn the dial clockwise 2-3 times. The turning of the dial will rotate the match and screw the match down into the candle block. This will start the chemical reaction, which will produce oxygen. Once oxygen is flowing, close the lid and place the face mask onto patient.

Here's a summary of the acceptance criteria and study information for the Rugged Oxygen Generator (ROG) based on the provided document:

Acceptance Criteria and Device Performance

Study Information

The provided document describes non-clinical bench testing to demonstrate that the subject device met its acceptance criteria. This is not a study on diagnostic accuracy or comparative human-AI performance.

1. Sample size used for the test set and the data provenance: Not explicitly stated as this is non-clinical bench testing of a physical device. The testing was conducted by the sponsor, Molecular Products Ltd. (UK).

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for device performance features like oxygen purity, flow rate, and temperature is established through direct measurement and adherence to specifications.

3. Adjudication method for the test set: Not applicable for non-clinical bench testing. Performance metrics are measured directly.

4. 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 an oxygen generator, not an AI-powered diagnostic tool.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not an algorithm. Bench testing evaluates the device's inherent performance.

6. The type of ground truth used: Direct physical measurements and adherence to engineering and performance specifications (e.g., flow rate, purity, temperature limits). Biocompatibility testing was also performed, where the ground truth is established by relevant ISO standards (ISO 18562-2 and ISO 18562-3) and their pass/fail criteria.

7. The sample size for the training set: Not applicable. This is a physical device, not a machine learning model.

8. How the ground truth for the training set was established: Not applicable.

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