(41 days)
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
| Feature/Parameter | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Oxygen output flow | Up to a total maximum flow of 33 liters-per-minute (LPM) at 50 psig | 33 liters-per-minute at 50 psig |
| Oxygen concentration purity | 93% minimum | 93% minimum, with an oxygen purity level average of 95% |
| Medical air output flow | Up to a total of 30 liters per minute (LPM) at 50 PSIG | Up to a total of 30 liters per minute at 50 PSIG |
| Compatibility | Compatible with specified commercial oxygen-consuming equipment and accessories (D, E, H, K cylinder-filling accessories, ventilators, cannulas, Draeger Narkomed Anesthesia machines and Impact Univent/Eagle 754/754M Ventilators). | 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. |
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.
§ 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).