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WARTNER PRO® is intended for the treatment of common warts and plantar warts in adults and children over the age of 4. Common warts are recognized by the rough 'cauliflower-like' appearance ci the surface. The plantar wart is recognized by its location only on the bottom of the foot, its tenderness, and the interruption of the footprint pattern. The product is intended as an OTC device, which will be marketed to professionals, allied professionals, and semi-professionals.

WARTNER PRO® is a cryosurgical system for the treatment of warts. It consists of

• A canister filled with 125 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.
• 42 Foam applicators in three different sizes (6 mm, 7 mm, 8 mm) .
• An applicator stick/key for holding a foam applicator which is required to . dispense the liquid to the applicator, and is held by the person during treatment
• . Information booklet
  The pressurized canister is filled with dimethyl ether and propane, which acts as a cryogen. The key is fitted with a foam applicator, which is inserted into the safety valve opening in the canister. The valve releasing the cryogen can only be actuated when the key is in place and depressed. When the key is depressed it saturates the foam applicator with the cold cryogenic gases and lowers the temperature of the applicator to approximately -50℃. The foam applicator is then placed on the wart. The freezing kills the wart and the infected skin causing the wart to fall off within a few days.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the WARTNER PRO® device:

The provided text is a 510(k) summary for a cryosurgical system called WARTNER PRO®. It focuses on demonstrating substantial equivalence to predicate devices rather than detailing independent clinical studies with specific performance metrics against pre-defined acceptance criteria. Therefore, many of the requested elements for a typical clinical study, such as specific acceptance criteria for efficacy or safety, effect sizes from MRMC studies, or detailed ground truth establishment, are not explicitly present.

However, based on the information provided, we can infer some "acceptance criteria" through the lens of performance equivalence to the predicate device and the laboratory testing described.

1. Table of Acceptance Criteria and Reported Device Performance

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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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