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Wartie® Wart Remover is intended for over-the-counter treatment of common warts and plantar warts to be used in adults and children 4 years of age and older.

Wartie® Wart Remover is indicated for the over-the-counter treatment of common warts for patients aged 4 years and older.

The Wartie® Wart Remover is effective in the treatment of warts by providing an over the counter cryosurgery product (for the treatment of warts), to be used at home.

Wartie® Wart Remover consists of:

• A pressurized canister filled with 50ml of the compressed liquid gas dimethy) ether.
• A custom application unit used to administer the cold delivered by the cryogen to the wart.
• Instructions for use in which you can read about the product how it works, how to use the product to treat warts, warnings and limitations.

Wartie® Wart Remover technology involves freezing a wart (common and/or platar) using a very cold releasing liquid gas (cryogen) into a patented-pending applicator which, in turn become very cold and is able to freeze the skin. The freezing of the skin causes damage to the cells housing and protecting the wart. The latter either develops a blister underneath and falls off, or the damaged skin cells are discarded by the body, thereby also effectively removing the wart and the virus.

Wartie® Wart Remover contains the following materials:
Cap: PP
Cone: POM
Nose Piece: Bronze coated with Nickel
Ring: POM
Can: Aluminum

This submission for the Wartie® Wart Remover is a 510(k) premarket notification, which seeks to demonstrate substantial equivalence to legally marketed predicate devices, rather than establishing acceptance criteria and proving performance through a standalone clinical study against those criteria. Therefore, much of the requested information about acceptance criteria, study sizes, ground truth establishment, expert roles, and MRMC studies is not directly applicable or available in this type of submission.

However, based on the provided text, I can infer and extract the following:

1. A table of acceptance criteria and the reported device performance:

Since this is a 510(k) submission, there isn't a table of explicit numeric "acceptance criteria" and "reported device performance" in the traditional sense of a clinical trial proving efficacy against pre-defined metrics. Instead, the "acceptance criteria" for a 510(k) revolve around establishing substantial equivalence in terms of intended use, indications for use, technological characteristics, safety, and effectiveness compared to predicate devices.

The "reported device performance" is primarily based on bench testing and biocompatibility evaluation, demonstrating equivalence to the predicates, particularly in heat transfer and safety.

2. Sample sized used for the test set and the data provenance:

• Test Set Sample Size: Not applicable in the context of this 510(k) submission for efficacy; no patient test set mentioned for performance claims.
• Data Provenance: The primary performance evidence comes from bench testing using a "biological tissue skin test model." The country of origin for the studies is not specified, but the applicant (YouMedical BV) is based in Amsterdam, The Netherlands. The testing described is prospective bench testing, comparing the device against multiple predicates.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable as there was no patient test set requiring expert ground truth for efficacy. The "ground truth" for the bench testing would be the physical measurements of cryogenic performance on the tissue model and comparison to predicate devices, which does not involve experts establishing a diagnostic ground truth in the typical clinical sense.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not applicable as there was no patient test set requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No MRMC study was done. This device is a cryosurgical unit, not an AI-assisted diagnostic or treatment system.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• This device is a physical cryosurgical unit, not an algorithm. Standalone performance was demonstrated through bench testing on a biological tissue skin model, comparing its physical performance to other similar devices.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• For the bench testing, the "ground truth" was derived from physical measurements on a biological tissue skin test model and direct comparison of performance metrics (e.g., heat transfer efficiency, skin adherence) against predicate devices. The safety evaluation primarily relies on literature data, chemical characterization, and ISO 10993 biocompatibility testing.

8. The sample size for the training set:

• Not applicable. There is no training set mentioned, as this is not an AI/ML device.

9. How the ground truth for the training set was established:

• Not applicable.

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