(104 days)
The O2 Concepts Oxlife Independence is indicated on a prescription basis for the administration of supplemental oxygen. It is not intended for life support, nor does it provide any patient monitoring capabilities.
The Oxlife Independence is a portable oxygen concentrator that enables patients requiring supplemental oxygen to be treated in a home environment, in an institutional environment or in a vehicle/mobile environment. The Oxlife Independence utilizes O2 Concepts' Dynamic Network Analysis (DNA) technology to provide equipment performance, location and usage data to O2 Concepts and its customers via cellular and GPS connection. The device delivers 87%-95% pure oxygen to a patient through a standard single lumen nasal cannula. The Independence detects a patient breath and delivers a bolus of oxygen during the inhalation period in pulse mode or delivers a continuous flow of oxygen in continuous mode.
This document describes the O2 Concepts Oxlife Independence Model 301-0001, a portable oxygen concentrator, and its 510(k) submission for FDA clearance. The information provided is primarily focused on demonstrating substantial equivalence to a predicate device, rather than an AI/ML software as a medical device (SaMD). As such, the request for specific AI/ML-related acceptance criteria and study details (like MRMC studies, ground truth establishment for training sets, or sample sizes for test/training sets in the context of AI model performance) are not directly applicable or available in the provided text.
The document focuses on engineering and usability testing for a hardware device, not the performance claims of an AI algorithm.
However, I can extract and present the available acceptance criteria and performance data for this hardware device based on the provided text, while explicitly stating where requested information related to AI/ML is not applicable or not found.
Here's an attempt to structure the information based on your request, noting the limitations of the provided document in the context of AI/ML performance studies:
Acceptance Criteria and Device Performance for O2 Concepts Oxlife Independence Model 301-0001
This device is a hardware portable oxygen concentrator, and its clearance is based on demonstrating substantial equivalence to a predicate device, primarily through engineering performance testing and usability studies. It is not an AI/ML algorithm or SaMD. Therefore, many of the requested criteria related to AI/ML performance (e.g., AUC, sensitivity/specificity, MRMC studies, training set details for an AI model) are not relevant or described in this submission.
1. Table of Acceptance Criteria and Reported Device Performance
The document describes performance in terms of meeting various standards and demonstrating equivalence to the predicate. The "acceptance criteria" here are largely implied by compliance with recognized standards and successful verification/validation testing.
| Acceptance Criteria (Implied by Standards/Testing) | Reported Device Performance |
|---|---|
| Oxygen Concentration | |
| Deliver 87-95% pure oxygen. | Achieves 87-95% oxygen concentration. |
| Flow Rates | |
| Deliver specified flow rates in pulse and continuous modes. | Pulse mode settings: 0.5 to 6.0 (8ml - 96ml). Continuous mode settings: 0.5 to 3.0 LPM. Adjustable in 0.5 increments for both modes. |
| Biocompatibility | |
| Compliance with ISO 10993-1. | Evaluation conducted in accordance with FDA Guidance Document on ISO 10993-1. PM2.5 levels |
§ 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).