(286 days)
CONTEC™ Oxygen Concentrator, OC3D, is intended to provide supplemental oxygen in a home, institutional environment. The device is only used for adult and prescription use only.
The Oxygen Concentrator is a small and portable oxygen concentrator. It consisted of air compressor, adsorption tower of molecular sieve, oxygen sensor and flow meter. It adopts pressure swing absorbers(PSA) directly concentrate the medical oxygen from the air.
The machine takes the advantages of small in volume, light in weight, convenient in moving (as it has turning truckle), stable in performance, easy in operating, low in noise, which complies with requirements of medical device.
The OC3D is divided into power module, MCU control module, Pressure detection module, Oxygen concentration detection module, alarm module, Compressor and fan drive module, Solenoid valve drive module, Display driver module, Work indication module, button detection module.
The provided text is a 510(k) summary for the CONTEC™ Oxygen Concentrator Model OC3D. It outlines the device's technical specifications, comparison to a predicate device, and the non-clinical tests performed to demonstrate substantial equivalence.
However, the questions you've asked relate specifically to the Acceptance Criteria and Study Design for an AI/ML-based medical device performance evaluation. The provided document is for an oxygen concentrator, which is a physical medical device, not an AI/ML algorithm. Therefore, the information requested in your prompt (e.g., sample size for training/test sets, expert adjudication, MRMC studies, ground truth establishment) is not present in this document because it doesn't apply to the type of device being described.
The document discusses:
- Acceptance Criteria for the Oxygen Concentrator (implied by meeting standards and comparison to predicate): This is shown in the "Table 7-1 Comparison of Technology Characteristics" and the "Non-Clinical Test Conclusion" sections. The device is deemed acceptable if its performance (e.g., oxygen concentration, flow rates, alarms, electrical safety, EMC) meets the requirements of specified international standards (IEC 60601-1, ISO 80601-2-69, etc.) and is comparable to a legally marketed predicate device.
- Study Proving Acceptance: Non-clinical tests were performed to verify compliance with these standards and the substantial equivalence to the predicate device. These tests are not "studies" in the AI/ML sense (i.e., not involving large datasets of images and human interpretation). They are engineering and performance validation tests.
Given the mismatch between your prompt and the provided document, I cannot fulfill your request for AI/ML-specific details.
§ 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).