(311 days)
The Oxygen Concentrator is intended for the administration of supplemental oxygen. This device is not intended for life supporting nor does it provide any patient monitoring capabilities. The system will be operated by trained personnel, at home, in community health care and medical institutions.
The Oxygen Concentrator adopts the principle of pressure swing adsorption technology. At normal temperature, the device can continuously supply a high concentration of supplemental oxygen (93%±3%). The main function of the proposed device includes supplying supplemental oxygen. The device also includes alarms for high temperature, low oxygen output, and interruption of power. The proposed device includes three models, which are M50, M40 and M30. The only difference of the three models is flow rate.
The provided document pertains to a 510(k) premarket notification for an Oxygen Concentrator. As such, it describes a medical device, not an AI/ML algorithm. Therefore, many of the requested details regarding acceptance criteria, study design for AI performance, expert adjudication, and ground truth establishment are not applicable to this document.
The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing and comparison of technical characteristics.
Here's a breakdown of the relevant information from the document, addressing the applicable parts of your request:
1. Table of acceptance criteria and the reported device performance
The document does not present "acceptance criteria" in the typical sense of a target performance metric for an AI algorithm. Instead, it describes compliance with established medical device standards and comparison to a predicate device. The "performance" is demonstrated by meeting these standards and showing similar technical characteristics to the predicate.
Below is a table summarizing the technical characteristics of the proposed device and how they compare to the predicate, which serves as the basis for the substantial equivalence determination. The "acceptance criteria" here are implied by the predicate device's characteristics and relevant standards.
| Item | Acceptance Criteria (Implied by Predicate/Standards) | Reported Device Performance (Proposed Device) |
|---|---|---|
| Classification | Class 2 | 2 |
| Product Code | CAW | CAW |
| Regulation Number | 21 CFR 868.5440 | 21 CFR 868.5440 |
| Intended Use | Administration of supplemental oxygen; not life-supporting; no patient monitoring; operated by trained personnel. | Administration of supplemental oxygen; not life-supporting; no patient monitoring; operated by trained personnel, at home, in community health care and medical institutions. |
| Use Environment | Home, hospital, and medical facility | Home, community health care, and medical institutions |
| Operation Principle | Pressure Swing Adsorption (PSA) technology | Pressure Swing Adsorption (PSA) technology |
| Oxygen Purity | 93% +/- 3% | 93% +/- 3% |
| Flow Type | Continuous flow | Continuous flow |
| Flow Rate | 0.5 - 15 L/min | M30: 0-3 L/min, M40: 0-4 L/min, M50: 0-5 L/min |
| Sound Level |
§ 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).