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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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Wartner Wart Removal System is intended for the over-the-counter treatment of common warts.
Wartner Wart Removal System is indicated for OTC treatment of common warts.
Wartner Wart Removal System is intended for the treatment of common warts.

Wartner Wart Removal System is a cryosurgical system for the treatment of warts. It consists of

• A canister filled with 35 ml of a liquid mixture of the compressed gases . dimethyl ether and propane. This gas mixture does not harm the ozone layer, and has a four-year shelf life.
• . Ten foam applicators
• . An applicator stick/key for holding a foam applicator, required to dispense the liquid to the applicator, and held by the person during treatment
• An illustrated description of how to use the product .

The provided text describes the Wartner Wart Removal System and focuses on its substantial equivalence to a predicate device rather than presenting a detailed study with specific acceptance criteria and performance metrics for the new device. Therefore, many of the requested elements (like sample size for test sets, number of experts for ground truth, MRMC study results, etc.) are not available in this document.

However, based on the information provided, here's what can be extracted and inferred:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information for this Section: The document does not explicitly state quantitative "acceptance criteria" for clinical effectiveness (e.g., "X% of warts removed within Y weeks"). The focus is heavily on equivalence to the predicate.

2. Sample Size used for the Test Set and Data Provenance

• Sample Size: Not specified. The document describes laboratory testing and comparisons to predicate device characteristics, but no human clinical trial involving a "test set" of patients is detailed.
• Data Provenance: The document describes laboratory testing. It does not mention clinical data or its provenance (e.g., country of origin, retrospective/prospective).

3. Number of Experts used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

• Not applicable as no clinical test set requiring expert-established ground truth is described. The safety and effectiveness claims are based on substantial equivalence to a predicate device and laboratory testing.

4. Adjudication Method for the Test Set

• Not applicable as no clinical test set requiring adjudication is described.

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

• Not applicable. This device is a cryosurgical wart removal system, not an AI or imaging diagnostic device. Therefore, no MRMC study or AI assistance is relevant.

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

• Not applicable as this is a physical medical device, not an algorithm.

7. The type of ground truth used

• The "ground truth" for the claims in this submission appears to be derived from:
  • Predicate Device Characteristics: Comparison of physical and chemical properties, design features, and intended use with the legally marketed predicate device.
  • Laboratory Measurements: Explicit measurements of temperature (-56.4°C applicator surface,

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Ask a specific question about this device