(238 days)
The OGL is intended to be used by emergency response personnel in military and commercial applications to produce emergency source of 93% USP liquid oxygen (LOX) which will be transferred into portable LOX systems. The portable LOX systems are used as an emergency source of supplemental oxygen for patient(s) while being transported for a crisis situation to a health care facility. This medical device is for supplemental oxygen and is not intended to sustain or support life.
The OGL is a device that generates 93% USP oxygen gaseous, liquefy it into LOX and store up to 40 liters of LOX. It OGL is a single module that weighs approximately 730 LBS empty or 830 full of LOX. The system is 52" long, 33" wide and 48" tall if the wheels are deployed). The system has to forklift pockets to allow the system to be moved by a forklift. The system also has retractable wheels that allows for one or two persons to easily move the device on a flat smooth surface.
The OGL requires only 200-240 VAC, 50/60 Hz 30 amp single phase power supply for operation. The system is very simple to operate. The control panel has a mode switch that allows the user to make liquid oxygen (LOX), generate gaseous oxygen for the oxygen gas port or transfer the liquid oxygen to a separate device. The control panel also has fault indicators if there is a problem with the system, emergency stop button, hour meter, Dewar pressure gauge and LOX quantity gauge.
1. Acceptance Criteria and Reported Device Performance:
| Performance/Characteristics | Acceptance Criteria (Predicate Device K022684) | Reported Device Performance (OGL) |
|---|---|---|
| Oxygen Purity | 93% USP | 93% USP |
| Operating Temperature | 32°F to 90°F | 0°F to 120°F |
| Storage Temperature | -40°F to 158°F | 0°F to 130°F |
| Humidity | Up to 95% | Up to 95% |
| Storage Humidity | Up to 100% | Up to 100% |
| Oxygen Gas Outlet - Flow Rate | 45 LPM | 11 LPM |
| Oxygen Gas Outlet - Pressure | 50 PSIG | 7 PSI |
| Power (Compressor Module A & B) | 208-220 VAC, 60 Hz, Three Phase, 6.93 kW MAX | 200-240 VAC, 50/60 Hz, Single Phase, 6.3 kW MAX |
| Oxygen Concentrator Module Power | 110 VAC, 50/60 Hz, 100 W | Not applicable (integrated system) |
| High Pressure Fill Module Power | 110 VAC, 60 Hz, 600 W | Not applicable (integrated system) |
The OGL is largely compared to its predicate device (PTOCS K022684) based on a variety of functional and environmental parameters. The acceptance criteria are implicitly defined by the predicate device's characteristics. The OGL's reported performance is then compared to these, demonstrating both similarities and some differences that the manufacturer argues are insignificant for safety and effectiveness.
2. Sample Size and Data Provenance for Test Set:
The document does not explicitly mention a "test set" in the context of a clinical study or a labeled dataset for AI model evaluation. Instead, the performance evaluation relies on bench testing of the OGL device itself, comparing its physical and functional specifications against those of the predicate device.
- Sample Size: Not applicable in the typical sense of a data sample for AI training/testing. The "sample" is the manufactured OGL device itself.
- Data Provenance: The data comes from the internal bench tests conducted by Essex Industries, Inc. d/b/a Essex Cryogenics of MO as described in their Qualification Test Report (OTR-50C-0103-5 .- 7). The country of origin for this testing is presumably the United States, given the company's location in St. Louis, Missouri. The testing is prospective in the sense that it evaluates the device's performance post-manufacture according to predefined specifications.
3. Number of Experts and Qualifications for Test Set Ground Truth:
Not applicable. The ground truth for the device's technical specifications and performance characteristics (e.g., oxygen purity, flow rate, environmental tolerances) is established through instrumentation and measurement according to engineering and quality assurance standards, not by human expert consensus or interpretation of images/data.
4. Adjudication Method for Test Set:
Not applicable. There is no human interpretation or subjective assessment that would require an adjudication method. The testing involves objective measurements and functional verification against established engineering specifications.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for AI-powered diagnostic or screening devices where human reader performance is a key metric. The OGL is a medical device for oxygen generation and liquefaction, and its evaluation focuses on its technical and functional performance, not its impact on human reader accuracy.
6. Standalone (Algorithm Only) Performance:
Not applicable. The OGL is a physical medical device; it is not an algorithm that performs a standalone function (e.g., image analysis) without human interaction. While it contains software with a microprocessor, its "performance" is evaluated as an integrated system, not as a standalone algorithm in the AI sense.
7. Type of Ground Truth Used:
The ground truth used for evaluating the OGL's performance is based on engineering specifications, objective physical measurements, and functional tests to ensure compliance with design requirements and comparability to the predicate device. For example:
- Oxygen Purity: Measured by a purity analyzer.
- Dimensional Examination: Measured with appropriate tools.
- Weight: Measured on a scale.
- Operating Temperature/Humidity: Tested under controlled environmental conditions.
- Functional Testing: Verifying delivery rates, pressure, normal evaporation rate, liquid transfer, and fault indicator operation.
8. Sample Size for the Training Set:
Not applicable. This device is not an AI/ML system that utilizes a training set of data. Its design and manufacturing are based on engineering principles and established medical device regulations, not machine learning.
9. How the Ground Truth for the Training Set was Established:
Not applicable, as there is no training set for this device.
§ 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).