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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

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

The provided document describes laboratory testing and comparison to predicate devices rather than a clinical human subject test set for efficacy.

• Test Set Sample Size: Not applicable in the context of a clinical study. For the laboratory testing, while it mentions "Several lengths, sizes, and shapes of foam were tested," a specific quantitative sample size for this internal testing is not provided.
• Data Provenance: The data appears to be internal laboratory testing data from Wartner Medical Products. No information is given about the country of origin of subjects/data (as it's not a clinical study) or if it's retrospective or prospective.

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

This information is not provided in the document. The filing is a 510(k) based on substantial equivalence, relying on physical and functional comparisons to predicate devices and internal lab measurements, not on clinical expert consensus for ground truth on patient outcomes.

4. Adjudication Method for the Test Set

This information is not applicable as there is no mention of a test set requiring adjudication in the context of a clinical study or human subject data.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done or described in this 510(k) summary. This type of study comparing human readers with and without AI assistance is not relevant to a cryosurgical device for wart removal, which is a direct treatment device, not an imaging or diagnostic aid.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This device is a cryosurgical tool, not an algorithm or AI system. Its performance is related to its physical properties (temperature, cryogen, applicator design) and its ability to deliver the therapy as intended, not an algorithm's standalone performance.

7. Type of Ground Truth Used

The "ground truth" for the device's technical specifications and equivalence is established through:

• Laboratory Measurements: For physical characteristics like applicator temperature (-56.4°C).
• Chemical and Material Analysis: Confirming identical cryogen composition and applicator foam material to the predicate device.
• Design Comparison: Verifying similarity in application method, safety features, and overall design to predicate devices.
• Labeling Comparison: Ensuring comparable instructions for use, warnings, and indications, particularly by referring to existing predicate devices for the plantar wart indication.

8. Sample Size for the Training Set

There is no mention of a "training set" in the context of this device. A training set is typically used for machine learning models, which is not applicable here. The device's design and characteristics were developed through engineering processes and laboratory testing, rather than a data-driven training process.

9. How the Ground Truth for the Training Set Was Established

Since there is no training set mentioned or implied for this device, this question is not applicable.

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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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