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The POGS 33C is intended to provide medical grade air and oxygen (USP oxygen 93%) at 50 PSIG nominal and lower output pressures in hospitals, surgical suites, and other clinical settings in military facilities only. The POGS 33C is compatible with commercial oxygen-consuming equipment and accessories, including D, E, H, and K cylinder-filling accessories, ventilators, cannulas, Draeger Narkomed Anesthesia machines and Impact Univent/Eagle 754/754M Ventilators.

The Portable Oxygen Generation System 33 (POGS 33C) has been designed to The Fortable Oxygen Ocheration of Supplemental oxygen in a setting where liquid oxygen may be unavailable, and of medical air to drive respiratory equipment. liquid oxygen may be unavaliable, and sed medical missions require medical support systems Aeromedical evacuation and ground ban. The gaseous oxygen generator will also be required Capable of providing therapoule oxygen. The gassessing and the oxygendriven equipment included in the AFMS deployable medical assemblages. Requirements are differi equipment included in the uspicy and mational requirements document that has been issued by the United States Air Force. This system is based on the Pressure Swing Adsorption principle and uses a molecular sieve to separate gases from the filtered ambient air. The oxygen is stored and delivered to the patient(s) through one of four ports with a total maximum flow of 33 liters-per-minute at 50 psig. The oxygen concentration purity level is at 93% minimum, with an oxygen purity level average of 95%. Included with the generator is a secured accessory kit including medicalgrade oxygen hose and flow regulators for the outlets. Medical air output of up to a total of 30 liters per minute at 50 PSIG is also provided.

Acceptance Criteria and Study for Portable Oxygen Generator System: POGS 33C

This document describes the acceptance criteria and the study that demonstrates the Portable Oxygen Generator System: POGS 33C meets these criteria, based on the provided 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

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

The 510(k) summary explicitly states that "Non-clinical bench testing" was conducted.

• Test Set Sample Size: The document does not specify the sample size used for the bench testing. It's implied that typical engineering validation and verification protocols would be followed, but no specific numbers are provided.
• Data Provenance: The testing was conducted by On Site Gas Systems, Inc. This indicates the data is prospective as it was generated specifically for the 510(k) submission. The country of origin for the data is implicitly the United States, where On Site Gas Systems, Inc. is located.

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

• Number of Experts: Not applicable/not mentioned. This was non-clinical bench testing, not a study involving expert interpretation of medical data.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The "ground truth" for the performance parameters (flow, pressure, purity) would be established by calibrated measurement instruments rather than human adjudication.

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

• MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is an oxygen generator, and its performance is evaluated through objective physical measurements rather than human interpretation of medical cases.

6. Standalone Performance Study

• Standalone Study: Yes, a standalone performance evaluation was conducted. The "non-clinical bench testing" described evaluates the algorithm (or the device's functional components) directly on its ability to produce oxygen and medical air according to specifications, without human intervention as part of the primary performance assessment.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth for this device's performance is based on objective physical measurements obtained from calibrated instrumentation. This includes measurements of oxygen purity, flow rate, and pressure. These are quantifiable, verifiable physical properties.

8. Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This device is a physical medical device (an oxygen generator), not an algorithm or AI model that requires a training set in the conventional sense. The "training" for such a system would involve engineering design, prototyping, and iterative testing, but not a distinct "training set" of data.

9. How Ground Truth for the Training Set Was Established

• Ground Truth for Training Set: Not applicable. As this is a physical device, a "training set" with established ground truth is not relevant to its development in the context of typical AI/algorithm studies. The device's design and engineering parameters are based on scientific principles and industry standards for oxygen generation, which are validated through rigorous bench testing.

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The POGS is intended to provide medical grade air and oxygen (USP oxygen 93%) at 50 PSIG nominal and lower output pressures in hospitals, surgical suites, and other clinical settings in military facilities only. POGS is compatible with commercial oxygen-consuming equipment and accessories, including D,E,H, K cylinder-filling accessories, ventilators, cannulas, and Draeger Narkomed Anesthesia Machine.

The FDA-cleared On Site Gas Systems' Portable Oxygen Generation System 33, "POGS 33", (K020362) is being modified to include medical air, and compatibility with the Draegar Narkomed Anesthesia Machine. The system uses PSA technology, and supplies medical grade air and oxygen (USP oxygen 93%) at 50 PSIG nominal and lower output pressures in battlefield/ hospital settings in military facilities only.

The POGS 33 utilizes the same Draegar Narkomed Anesthesia Machine as the predicate, PVOCS. The POGS 33 utilizes the same oilless scroll feed compressor in the production of medical air as does the predicate, PVOCS.

The variations of the POGS device to the predicate are greater oxygen total flow, to accommodate more cannulas per device. The variations are designed and tested for the same indication of use, safety and effectiveness. Variations are substantially equivalent to the predicate device.

This document, K030920, describes the Portable Oxygen Generation System with Medical Air (POGS 33) manufactured by On Site Gas Systems, Inc. It's a 510(k) summary seeking substantial equivalence to existing legally marketed devices.

Here's an analysis of the acceptance criteria and study data:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the POGS 33 are based on recognized FDA standards for oxygen concentrators and medical air.

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

The document does not specify a sample size for a test set in the context of clinical studies with patients. The performance data presented refers to the device meeting established quality and performance standards rather than results from a pre-market clinical trial involving human subjects or real-world data.

The data provenance is from non-clinical tests conducted by the manufacturer to demonstrate compliance with recognized standards. This is not retrospective or prospective clinical data.

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

Given that this is a 510(k) submission based on non-clinical performance data against established standards, the concept of "ground truth established by experts" as it would apply to a diagnostic or clinical AI device is not applicable in this context. The "ground truth" here is the set of criteria defined by the recognized standards (ASTM F 1464-93 and USP Standards). The expertise lies in the development and validation of these standards themselves, not in a specific set of experts adjudicating results for this particular device's performance test.

4. Adjudication Method for the Test Set

Again, an adjudication method for a "test set" in the sense of expert review of clinical cases is not applicable here. The device's performance is measured against objective, verifiable parameters defined by the ASTM and USP standards. Passing these tests constitutes meeting the "acceptance criteria."

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

No MRMC study was done, as this is a device for generating oxygen and medical air, not a diagnostic imaging device or an AI application intended to assist human readers in interpretation. Therefore, there is no effect size related to human reader improvement with or without AI assistance.

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

The device is a machine that generates gases. Its performance is inherently "standalone" in that it produces oxygen and medical air autonomously based on its design and manufacturing. There is no "algorithm only" performance separate from the physical device's operation. Its performance is evaluated independently against physical/chemical standards.

7. The Type of Ground Truth Used

The "ground truth" used for this device is based on established industry and regulatory standards:

• ASTM F 1464-93 for oxygen concentrators.
• USP Standard for oxygen.
• USP Standard for Medical Air.

These standards define the acceptable purity, concentration, and other performance characteristics for medical-grade oxygen and air.

8. The Sample Size for the Training Set

This device does not utilize a "training set" in the context of machine learning or artificial intelligence. It's a mechanical and chemical system. Therefore, the concept of a training set sample size is not applicable.

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

Since there is no training set for this type of device, the question of how its ground truth was established is not applicable. The "ground truth" relevant to this device's approval are the performance specifications mandated by the recognized standards it claims to meet.

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