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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, < -50°C for 5 minutes).
  • Material Characterization: Reference to published literature for S616 foam.
  • Labeling Review: Assessment of clarity and consistency with predicate device labeling.

8. The Sample Size for the Training Set

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

9. How the Ground Truth for the Training Set was established

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

Summary of Study (Based on Provided Document):

The document describes a substantial equivalence review for the Wartner Wart Removal System (Over-the-Counter use) against a predicate device (Wartner Wart Removal System for prescription use) and several other labeling predicates. The "study" presented here is primarily a comparative analysis of technological characteristics, safety features, and labeling between the proposed device and its predicates, supported by some laboratory testing of physical properties.

• Laboratory Testing: Conducted to determine the average temperature of the applicator surface after saturation (-56.4°C) and the duration it maintains a temperature below -50°C (up to five minutes). Foam characteristics (liquid retention, shape versatility) were also tested. The details of these lab tests (sample sizes, methods) are not provided beyond the results.
• Comparison to Predicate Devices: A detailed comparison was performed covering:
  • Application Method: Identical applicators.
  • Applicator Effectiveness Duration: Identical to predicate.
  • Cryogen: Identical composition.
  • Safety/Ease of Use: Identical safety valve design.
  • Biocompatibility: Identical cryogen and foam material to predicate, with foam being well-characterized in literature.
  • Indications for Use: OTC treatment of common warts (vs. prescription use by a physician for the primary predicate).
  • Labeling: Developed for consumer clarity, safety, self-diagnosis, and similar to predicate device warnings.

The conclusion drawn from this comparative analysis and limited laboratory testing is that the proposed device is substantially equivalent to the predicate device in terms of safety and effectiveness, and identical in crucial technological characteristics, making it suitable for its intended OTC use. No clinical trials or expert-adjudicated test sets are described in this 510(k) summary.

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