Search Results

Emergency Use - OTC: Intended to produce oxygen for emergency use. There is a minimum 6 LPM flow rate for at least 15 minutes established a minimum total oxygen capacity of 90 liters. Environment of use - locations where emergency oxygen maybe needed.
Rx use: A portable oxygen generator intended to produce oxygen to provide supplemental oxygen as prescribed by a physician. Environment of use – Home, institutional, travel / mobile environments.

A portable oxygen generator that utilizes a chemical reaction to generate oxygen. It is available in two versions: Emergency Use - OTC and Rx use. The Emergency Use version provides a minimum flow rate of 6 LPM for at least 15 minutes with a total oxygen capacity of 90 liters. The Rx use version provides variable flow rates (0.5 LPM for 60 minutes/30 liters capacity and 3 LPM for 30 minutes/90 liters capacity) as prescribed by a physician. Both versions are single use and disposable and use a standard oxygen mask or nasal cannula for patient interface.

The provided text describes two devices, O2-in-a-box™ for Emergency Use (OTC) and O2-in-a-box™ for Rx Use, which are portable oxygen generators. The document focuses on demonstrating substantial equivalence to predicate devices rather than independent performance studies with detailed acceptance criteria. However, based on the comparative tables and performance testing sections, we can infer acceptance criteria and reported performance.

1. Table of Acceptance Criteria and Reported Device Performance

Here's a table summarizing the acceptance criteria (primarily based on predicate device specifications and stated minimums) and the reported performance of the O2-in-a-box™ devices.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state sample sizes for performance testing. It mentions "Performance testing was performed" and lists various tests, concluding that "The proposed devices met and passed all the performance testing as outlined above." This implies that a sufficient number of units were tested to demonstrate compliance, but specific numbers are not provided.

The data provenance is from bench testing conducted by Get-O2, Inc. The document does not specify the country of origin of the data beyond "Get-O2, Inc." being located in Westport, CT, USA. It is prospective testing performed on the O2-in-a-box™ devices.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable in this context. The "ground truth" for these tests relates to physical measurements and chemical analyses (e.g., oxygen concentration, flow rate, temperature, chemical composition). These are objective measurements determined by laboratory equipment and standard test methods (e.g., EPA TO-15 VOC, NIOSH 0500 PM2.5), not through expert consensus or interpretation.

4. Adjudication Method for the Test Set

This is not applicable. As mentioned above, the performance tests involve objective measurements, not subjective evaluations requiring adjudication. The results are either within the specified limits or not.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data, and the AI's impact on their performance is evaluated. The O2-in-a-box™ devices are portable oxygen generators, which are therapeutic medical devices whose performance is assessed through bench testing against physical and chemical specifications, not by human reader interpretation.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

Yes, standalone performance testing was done. The entire performance testing described (VOC/PM2.5, Bacteria/Mold, Environmental, Mechanical, Flow Rate, Duration, % Oxygen) assesses the device's inherent performance characteristics independent of human interaction during operation other than activating the device. The reported performance refers exclusively to the device's capabilities.

7. The Type of Ground Truth Used

The ground truth used for performance testing is based on objective physical and chemical measurements obtained through standard laboratory test methods. Examples include:

• Direct measurement of oxygen concentration using appropriate sensors.
• Measurement of flow rate and duration using flow meters and timers.
• Chemical analysis for VOCs, PM2.5, and residual hydrogen peroxide according to established methods (e.g., EPA TO-15 VOC, NIOSH 0500 PM2.5).
• Microbiological testing for bacteria and mold.
• Temperature measurements for housing and gas outlet.
• Mechanical stress tests for vibration.

8. The Sample Size for the Training Set

This is not applicable. The O2-in-a-box™ is a physical, chemical-reaction-based device, not an AI or algorithm-driven system that requires a "training set" in the machine learning sense. Its performance is inherent in its design and manufacturing.

9. How the Ground Truth for the Training Set Was Established

This is not applicable for the same reason as point 8. There is no AI training set for this device.

Ask a specific question about this device