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The HealthLife Oxygen Concentrator delivers supplemental oxygen in a nominal 9 liters-per-minute flow of 38% oxygen for inhalation with mask delivery to the patient.

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I am sorry, but the provided text does not contain the detailed information necessary to answer your request about acceptance criteria and a study proving a device meets them.

The document is a 510(k) clearance letter from the FDA for a device called "HealthLife Oxygen Concentrator." It confirms that the device is substantially equivalent to legally marketed predicate devices and outlines the regulatory requirements the manufacturer must follow.

Here's a breakdown of why I cannot extract the requested information based on the text:

• No acceptance criteria or device performance data: The letter does not describe any specific performance metrics (e.g., accuracy, sensitivity, specificity, flow rate stability over time, oxygen concentration percentage variance) that the device was tested against, nor does it present the results of any such tests.
• No mention of a study: While the FDA grants clearance based on data showing substantial equivalence, the letter itself does not describe any specific study design, sample sizes, data provenance, expert involvement, or ground truth establishment. These details would typically be found in the 510(k) submission itself, not the clearance letter.
• No AI component: The device is an "Oxygen Concentrator," a hardware medical device. There is no indication of any artificial intelligence (AI) component, which means questions about MRMC studies with AI assistance or standalone algorithm performance are not applicable.

In summary, the provided document is a regulatory approval letter and does not contain the technical study details you are asking for.

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