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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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Intended to produce oxygen for emergency use at 6 lpm flow rate for at least 15 minutes (90 liters).

The ROGS is a chemical based portable oxygen generator which generates 99% oxygen for at least 15 minutes at a flow rate of at least 6 lpm. It is a self-contained device with the oxygen delivered via standard oxygen face mask or nasal cannula.

The provided text describes the ROGS portable oxygen generator, a chemical-based device intended for emergency oxygen production. The acceptance criteria and the study proving it meets these criteria are outlined through a comparison to a predicate device (Molecular Products - POGS - K062153) and performance testing.

Here's an organized breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state a specific "sample size" for a test set in the traditional statistical sense for device performance. Instead, it mentions "Performance testing was performed" and lists various tests, implying that units of the ROGS device were tested against the specified parameters. The provenance of the data is retrospective, as the testing was performed and then summarized for the 510(k) submission. The country of origin for the device's manufacturer is the United Kingdom.

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

Not applicable. This device is a portable oxygen generator, not a diagnostic or AI-driven decision support system that would require expert-established ground truth for a test set. The "ground truth" here is objective physical and chemical measurements (e.g., % oxygen purity, flow rate, temperature).

4. Adjudication Method for the Test Set:

Not applicable. Given the nature of the device (physical oxygen generator), the performance evaluation relies on direct measurement against predefined specifications, not expert adjudication.

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

Not applicable. An MRMC study is relevant for AI-assisted diagnostic or interpretive tasks involving multiple human readers and imaging cases. The ROGS is a standalone physical device.

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

No, this is not an algorithm-only device. It is a physical device where its performance is inherently "standalone" in the sense that its oxygen generation function operates independently of human intervention during its use, once activated. The performance testing described (flow rate, purity, temperature, etc.) represents the intrinsic performance of the device itself.

7. The Type of Ground Truth Used:

The ground truth used for evaluating the ROGS device is objective physical and chemical measurements against engineering specifications and regulatory requirements. This includes metrics such as:

• Percent oxygen generated
• Flow rate (liters per minute)
• Duration of flow
• Temperature measurements (external container, outlet gas)
• Presence of VOCs, PM2.5, and Ozone.
• Resistance to environmental conditions (temperature, vibration).

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable, as there is no training set for this type of device.

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The Portable Oxygen Generator (POG) is intended to produce oxygen for emergency use at 6 lpm for at least 15 minutes.

The Molecular Products' POG is a chemical based portable oxygen generator which generates 99% oxygen for 15 minutes at a flow rate of 6 lpm. It is a self-contained device with the oxygen delivered via a standard oxygen face mask or nasal cannula.

The document describes the acceptance criteria and performance of the POG (Portable Oxygen Generator) device.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). It mentions "Testing" as a category, implying that tests were conducted, but lacks details on the experimental design.

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

Not applicable. This device is a portable oxygen generator, and its performance criteria are based on measurable physical properties (flow rate, oxygen concentration, temperature, duration), not on subjective expert assessment of medical images or conditions. Therefore, there is no mention of experts establishing ground truth in this context.

4. Adjudication Method for the Test Set

Not applicable, as expert adjudication is not relevant for the type of objective performance criteria evaluated for this device.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. The POG is a medical device for generating oxygen, not an imaging or diagnostic AI tool that would typically undergo an MRMC study. Its effectiveness is measured by its physical output characteristics.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This concept is not directly applicable. The POG is a physical device, and its performance is inherently "standalone" in how it generates oxygen. There isn't an algorithm or human-in-the-loop component in its primary function that would be separately evaluated in this manner. The reported performance metrics are for the device operating independently.

7. Type of Ground Truth Used

The ground truth for this device's performance is based on direct physical measurements and engineering specifications, such as a calibrated flow meter for flow rate, an oxygen analyzer for % oxygen, a timer for duration, and a thermometer for temperature.

8. Sample Size for the Training Set

Not applicable. The POG is a hardware device where performance is determined by its design and manufacturing process, not trained using a data set like an AI algorithm.

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

Not applicable, as there is no "training set" in the context of this physical device. Performance is validated through engineering tests and quality control.

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