(22 days)
The Puritan-Bennett Aeris 590 oxygen concentrator with OCI is intended to provide supplemental oxygen to patients who may have difficulty extracting oxygen from the air that they breathe. It is intended to be used with both pediatric and adult patients. It is not intended as life sustaining or life supporting device. The device has no contraindications.
An oxygen concentrator takes in room air, filters it and separates the nitrogen from the air under pressure, allowing only oxygen and trace gases to pass through to the oxygen outlet connection to the patient while exhausting a nitrogen-rich air mixture back into the room. The principle components of the Aeris 590 oxygen concentrator include a compressor, two molecular sieve containers, a valve system and a printed circuit board. The compressor draws in room air, pressurizes it and forces it through the pneumatic circuit of the device. As the air passes through one sieve container, the nitrogen bonds with the molecular sieve material within the pressurized container and allows only the oxygen and trace gases to flow out of the container. This oxygen rich mixture (+90% oxygen) is then delivered to the patient at a regulated pressure and flowrate. The valve system regulates the airflow through the sieve containers alternately. While one is pressurized and producing oxygen, the other is being depressurized and exhausting the nitrogen in preparation for the next cycle. A programmable logic device on the printed circuit board controls the timing of this cycling process. The OCI (Oxygen Concentration Indicator) provides an indication of the oxygen concentration of the output gas and includes alarm features.
Here's an analysis of the acceptance criteria and study information based on the provided text for the Puritan-Bennett Aeris 590 Oxygen Concentrator:
The provided document is a 510(k) Summary for the Puritan-Bennett Aeris 590 Oxygen Concentrator. It describes the device, its intended use, and claims substantial equivalence to a predicate device. It also briefly mentions performance testing.
The document does not contain the level of detail typically found in a robust study report for acceptance criteria, especially
when it comes to AI/ML device evaluations. It's a regulatory submission for a medical device that predates the common use of AI in such devices.
Therefore, many of the requested fields below will be marked as "Not Applicable" or "Not Provided" because this type of information is simply not present in a traditional 510(k) for a non-AI device.
Acceptance Criteria and Device Performance
The document states that the Aeris 590 oxygen concentrator successfully passed tests in several areas. It also mentions an improvement in oxygen concentration performance compared to its predicate device.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Electrical Safety | Successfully passed tests |
| Electromagnetic Compatibility (EMC) | Successfully passed tests |
| Mechanical/Climatic | Successfully passed tests |
| Software | Successfully passed tests |
| Device Performance | Successfully passed tests; improved oxygen concentration performance in the 1 to 4 L/min range and better performance at 5 L/min compared to the predicate device. Delivers over 90% oxygen at flow rates of 0 to 5 L/min. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not Provided. The document mentions "tests" but does not specify the number of units or any other sample size for these tests.
- Data Provenance: Not Provided. No information on the origin or type (retrospective/prospective) of data used for testing is given.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Number of Experts: Not Applicable for this type of device and testing. The "ground truth" for a device like an oxygen concentrator typically comes from engineering specifications, calibration standards, and validated measurement equipment, not expert human interpretation of complex data.
- Qualifications of Experts: Not Applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not Applicable. This concept is relevant for studies involving human interpretation or subjective assessments, which are not described here.
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 is not an AI/ML device, and no MRMC study comparing human readers (or users) with and without AI assistance was performed or is relevant to this device.
- Effect Size: Not Applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not Applicable. This device is a hardware oxygen concentrator with embedded software; it is not an algorithm evaluated in a standalone manner in the context of an AI/ML device. Its "performance" is inherent to its functionality.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: Primarily engineering specifications, validated measurement standards, and performance against defined physical and electrical parameters. For oxygen concentration, the ground truth would be established by calibrated oxygen analyzers.
8. The sample size for the training set
- Sample Size for Training Set: Not Applicable. This is not an AI/ML device, so there's no "training set" in the machine learning sense. The device is designed and manufactured based on engineering principles.
9. How the ground truth for the training set was established
- How Ground Truth was Established: Not Applicable. As there is no training set for an AI/ML model, there is no ground truth established in that context. Device design and validation are based on engineering standards and performance targets.
§ 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).