Search Results

The Owgels Oxygen Concentrator is intended to be used by patients with respiratory disorders who require supplemental oxygen. A high concentration of supplemental oxygen is supplied and a nasal cannula is used to channel oxygen from the concentrator to the patient. The Owgels Oxygen Concentrator can be used in a home, institution environments. The Owgels Oxygen Concentrator does not nor is it intended to sustain or support life. The device is intended for use in adults.

Owgels Oxygen Concentrator, Model : OZ-5-02TW0 adopts pressure swing adsorption principle, which can separate oxygen, nitrogen and other gas from the air, at constant temperature. The concentrator can generate oxygen with steady oxygen flowing out and reliable, adjustable flow. The device is capable of providing oxygen flow up to 5 LPM. The concentration of supplied oxygen is from 90%-96%. The weight of Owgels Oxygen Concentrator, Model : OZ-5-02TW0 is around 19kg.

This document is a 510(k) summary for the Owgels Oxygen Concentrator, Model OZ-5-02TW0, seeking FDA clearance for market. It focuses on demonstrating substantial equivalence to a predicate device, not on proving that an AI/ML device meets specific performance criteria.

Therefore, the requested information regarding acceptance criteria, AI/ML study details, sample sizes, expert involvement, and ground truth establishment cannot be found or inferred from the provided text.

The document describes the device as a medical oxygen concentrator and the testing performed is for traditional medical device safety and performance, such as:

• Biocompatibility testing (ISO 18562-1, ISO 18562-3, ISO 10993-5, ISO 10993-10, ISO 10993-17)
• Electrical safety and electromagnetic compatibility (EMC) (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-8, IEC 60601-1-11, and ISO 80601-2-69)
• Software Verification and Validation Testing (adhering to FDA guidance for software in medical devices, noting a "minor level of concern" for the software as it's not life-supporting)
• Performance Bench Testing (based on ISO 80601-2-69, including oxygen concentration and maximum flow performance after 8 hours of continuous operation)
• No animal study or clinical testing was required.

The "Performance Bench Testing" section is the closest to having "acceptance criteria," but it only states that the device was evaluated based on ISO 80601-2-69 and verified its oxygen production capacity. It doesn't provide specific numerical acceptance criteria or detailed results in a table format as requested.

The comparison table on pages 5-6 primarily focuses on technical specifications (e.g., oxygen concentration 93% ± 3%, flow 0-5 LPM, acoustic noise, alarms) and regulatory equivalences with its predicate device, not statistical performance of an AI/ML algorithm.

In summary, this document does not contain the information requested about an AI/ML device, its acceptance criteria, or the study proving it meets those criteria.

Ask a specific question about this device