(133 days)
The POGS 65/130 is intended to generate and deliver USP 93% supplemental oxygen. This device is intended to be used only by trained personnel in disaster relief and emergency preparedness situations, military settings or where bottled oxygen is not readily available.
The Portable Oxygen Generation System 65/130 (POGS 65) has been designed to accommodate medical personnel that require a portable, reliable source of supplemental oxygen in a setting where liquid oxygen may be unavailable. This system is based on the Pressure Swing Absorption principle and uses a molecular sieve to separate gasses from the filtered ambient air. The oxygen is stored and delivered to the patient(s) through the oxygen boost and distribution system. The POGS 65/130 is a system that generates USP 93% oxygen at a flow rate of up to 65 LPM at a pressure of 50-60 PSI. Included with the generator are medical-grade oxygen hose for both low and high pressure, spare parts and tools that are required, but may be not be easily accessible to the user. The POGS 65/130 is compatible with commercial oxygen consuming equipment and accessories, including D. E, H, K, and M cylinder filling accessories, ventilators, nasal cannulas, Draeger Narkomed Anesthesia machines and Impact Univent/Eagle 754/754M Ventilators. It also connects with the high pressure Hospital Oxygen Backup System and the low-pressure Patient Oxygen Distribution System. A complete POGS 65/130 system consists of two (2) feed air compressors, two (2) oxygen generators, one (1) boost and distribution center, and one (1) oxygen back-up system. Each feed air compressor and oxygen generator pair is designed to provide up to 65 LPM independently or can operate in parallel to achieve up to 130 LPM to provide the user flexibility in the deployment of their resources. The approach is modular and enables the user to add or subtract systems to meet the requirements of the situation. Each POGS 65 pair responds to the oxygen demand that is being used and when operated in parallel, will load share between the pair. The boost and distribution system receives the oxygen from up to two oxygen generators. The boost and distribution system can feed the oxygen to 1) the hospital distribution system, 2) fill the back-up system, 3) fill cylinders or 4) fill the hospital back-up system depending upon the requirements of the situation. To ensure patient care, the hospital distribution system has priority over all other options. One or more type of cylinder or back-up system may be filled in conjunction with supplying the hospital distribution system. The System includes the capability to evacuate high pressure oxygen cylinders to 25 inches Hg vacuum prior to filling.
The provided text describes the POGS 65/130 Portable Oxygen Generation System and its 510(k) summary. However, it does not contain the specific details required to fully address all parts of your request regarding acceptance criteria and a study proving those criteria.
The document primarily focuses on:
- The device's description, operation, and indications for use.
- Comparisons with a predicate device (POGS 33C) and improvements.
- The fact that non-clinical bench testing was performed.
Here's an attempt to answer your questions based only on the provided text, highlighting what is present and what is missing:
Acceptance Criteria and Study for POGS 65/130 Portable Oxygen Generation System
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Generate USP 93% oxygen | Generates USP 93% oxygen |
| Flow rate up to 65 LPM | Up to 65 LPM |
| Pressure of 50-60 PSI | 50-60 PSI |
| Compatibility with commercial oxygen consuming equipment and accessories (e.g., D, E, H, K, M cylinder filling accessories, ventilators, nasal cannulas, Draeger Narkomed Anesthesia machines, Impact Univent/Eagle 754/754M Ventilators, Hospital Oxygen Backup System, Patient Oxygen Distribution System) | Compatible as listed |
| Ability to operate with two (2) feed air compressors and two (2) oxygen generators | System consists of two (2) feed air compressors and two (2) oxygen generators. |
| Ability to provide up to 130 LPM (when two units operate in parallel) | Can operate in parallel to achieve up to 130 LPM. |
| Prioritization of hospital distribution system for oxygen supply | Hospital distribution system has priority over other options for oxygen supply. |
| Evacuation of high pressure oxygen cylinders to 25 inches Hg vacuum prior to filling | Includes capability to evacuate high pressure oxygen cylinders to 25 inches Hg vacuum prior to filling. |
| Meet ASTM F-1464-93 performance standard | Performance Standard ASTM F-1464-93 was used. |
| Oxygen purity evaluations sufficient for substantial equivalence | Non-clinical bench testing, including oxygen purity evaluations, found sufficient for substantial equivalence. |
Missing Information Regarding Acceptance Criteria:
The document states that "Requirements are based on the deployment oxygen system- medium (DOGS-M), operational requirements documents that have been issued by the United States Air Force and the United States Army." However, the exact quantitative acceptance criteria (e.g., specific thresholds for purity, flow rate stability, pressure consistency over time, or specific compatibility tests and their pass/fail criteria) from these military documents or the ASTM standard are not detailed in the provided text. The table above largely infers acceptance criteria from the reported performance claims.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified. The document only mentions "Non-clinical bench testing." The number of devices or test runs is not provided.
- Data Provenance: The testing was "conducted by On-Site Gas Systems, Inc." The country of origin of the data is implicitly the USA, where On-Site Gas Systems, Inc. is located. It is a non-clinical bench test, not data from human subjects, so retrospective or prospective doesn't directly apply in the usual clinical sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable. This was non-clinical bench testing of a device's physical output (oxygen purity, flow, pressure). There is no "ground truth" established by human experts in the context of diagnostic performance. The ground truth would be the direct measurement of the device's output parameters.
- Qualifications of Experts: Not applicable for the reasons above.
4. Adjudication method for the test set
- Adjudication Method: Not applicable. This was non-clinical bench testing. Adjudication methods like 2+1 or 3+1 typically apply to human interpretation of data where consensus is needed for ground truth.
5. 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
- MRMC Study: No. This device is an oxygen generator, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Performance: The non-clinical bench testing mentioned ("Performance Standard ASTM F-1464-93 was used," "Non-clinical bench testing conducted by On-Site Gas Systems, Inc. is sufficient in establishing substantial equivalence on the POGS 33C to the predicate device on which substantial equivalence is claimed, including oxygen purity evaluations.") could be considered "standalone" in the sense that they evaluated the device's inherent performance characteristics (oxygen output, purity, flow, pressure) without human intervention in the generation process itself. It's a test of the machine's output, not an algorithm's diagnostic performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: The ground truth for this device's performance would be the direct, objective measurement of the oxygen's physical properties (purity, flow rate, pressure) using calibrated laboratory equipment and standard measurement techniques.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This device is a physical oxygen generator, not an AI/machine learning algorithm that requires a "training set" in the computational sense.
9. How the ground truth for the training set was established
- How Ground Truth for Training Set was Established: Not applicable, as there is no training set for this type of 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).