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WARTNER® Wart Removal System is indicated for the over-the-counter treatment of common warts and plantar warts.

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This document, a 510(k) summary, does not contain the information requested about acceptance criteria and a study proving a device meets those criteria.

The provided text is a summary prepared for the FDA's 510(k) premarket notification process for the WARTNER® Wart Removal System. Its primary purpose is to demonstrate substantial equivalence to legally marketed predicate devices, not to present detailed performance study results against specific acceptance criteria.

Therefore, I cannot extract the following information from the given 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 their qualifications
4. Adjudication method for the test set
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size
6. If a standalone performance study was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

The document focuses on:

• Contact information of the submitter.
• Device name.
• Predicate devices used for comparison.
• The FDA's letter granting substantial equivalence.
• The intended indications for use.

These elements are standard for a 510(k) summary and do not delve into the specifics of performance studies as you've requested.

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