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The new Infant Oxygen Treatment Hood is designed to administer oxygen, under supervision of a physician, to infants or small children within a mukiplace hyperbaric chamber without physically having to hold the infant or child.

Infant Oxygen Treatment Hood

I'm sorry, but the provided text is a 510(k) clearance letter from the FDA for an "Infant Oxygen Treatment Hood." This document confirms that the device is substantially equivalent to a legally marketed predicate device and can proceed to market.

However, a 510(k) clearance letter typically does not contain the detailed information you are requesting regarding acceptance criteria and specific studies, sample sizes, expert qualifications, or ground truth establishment for software or AI-driven medical devices. These types of details are usually found in the original 510(k) submission document itself, which is not provided here.

Therefore, I cannot extract the following information from the given text:

• A table of acceptance criteria and the reported device performance
• Sample sizes used for the test set and the data provenance
• Number of experts used to establish the ground truth for the test set and their qualifications
• Adjudication method for the test set
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size
• If a standalone (algorithm only) performance study was done
• The type of ground truth used
• The sample size for the training set
• How the ground truth for the training set was established

The document focuses on the regulatory clearance process rather than the technical study results.

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