Search Results

To relieve nipples that are sore and cracked from breastfeeding.

Not Found

I'm sorry, but the provided text from the FDA 510(k) clearance letter for the "Soothing Gel Patch" does not contain the detailed information necessary to answer your request about acceptance criteria and a study proving the device meets those criteria.

This document is a clearance letter, which means the FDA has determined the device is "substantially equivalent" to a legally marketed predicate device. This type of clearance typically relies on demonstrating that the new device has the same intended use, technological characteristics, and safety and effectiveness as a predicate device, rather than requiring a full clinical study with specific acceptance criteria and detailed performance metrics to be proven.

The letter focuses on regulatory compliance and categorization, not on the technical performance data of the device itself.

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

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
6. If a standalone performance (i.e., algorithm only without human-in-the-loop) was done (This question is not relevant as it's a physical device, not an algorithm)
7. The type of ground truth used
8. The sample size for the training set (This question is not relevant as it's a physical device, not an AI/ML algorithm)
9. How the ground truth for the training set was established (This question is not relevant as it's a physical device, not an AI/ML algorithm)

To obtain this kind of information, you would typically need to review the full 510(k) submission summary or associated testing reports, which are not included in this FDA clearance letter.

Ask a specific question about this device