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Wart Freeze (private label trade mark: Wart Freezer, Cryogenic Wart Remover) is indicated for the removal of common and plantar warts.
The product is indicated for the removal of common and plantar warts.

Wart Freeze is a private label (private label trade mark: Wart Freezer, Cryogenic Wart Remover) over the counter cryosurgery product for the treatment of common and plantar warts. The device consists of the following:

• A pressurised dispenser (canister) containing as ingredient 38ml dimethylether (DME) with a . polypropylene applicator that is permanently attached (fixed) to the dispenser. The gas does not harm the ozone layer. The applicator is used to administer the cryogen directly to the wart. The applicator is cleaned after each use.
• Disposable 70% alcohol cleansing swabs for cleaning the applicator after each use .
• Instruction for use .
  The Wart Freeze (private label trade mark: Wart Freezer, Cryogenic Wart Remover) is a 21. cryosurgical system comprised of a dispenser containing as ingredient, dimethylether (DME), and a permanently attached (fixed) applicator to apply the cryogen directly to the wart.

The provided document is a 510(k) summary for a medical device called "Wart Freeze," which is an over-the-counter cryosurgery product for wart removal. The document focuses on establishing substantial equivalence to a predicate device (K101049) and demonstrating the safety and effectiveness of the modified device.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" in the typical sense of numerical thresholds for clinical performance. Instead, it demonstrates performance through comparative laboratory testing and characterization against a predicate device and established safety standards. The primary acceptance criterion here is substantial equivalence to the predicate device, especially in terms of functionality, safety, and indications for use.

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

The testing conducted for this device appears to be all laboratory-based or pre-clinical studies, not a human clinical trial test set in the traditional sense.

• Comparative laboratory testing: Involved "predicate devices using a phantom skin model." The sample size (number of phantom skin models or tests) is not specified.
• Applicator temperature laboratory test: Used "infrared camera technology." Sample size (number of tests/measurements) is not specified.
• Dose technique testing: Used "infrared (IR) camera technology." Sample size (number of tests/measurements for each dose technique) is not specified.
• Biocompatibility testing: Performed "in line with ISO 10993:5 Tests for in vitro cytotoxicity." While "testing was performed," the specific sample size (e.g., number of cell cultures, replicates) is not detailed.
• Chemical residual testing: "Laboratory testing was conducted." Sample size (number of extractions, analyses) is not specified.
• Inhalation studies on dimethylether: "Conducted by the suppliers." The US National Toxicological Programme (NTP) conducted "acute toxicity studies (LC50)" and "developmental toxicity studies" on mouse and rabbit models. The exact number of animals is not specified in this summary.

Data Provenance: All data appears to be from laboratory studies and existing toxicological literature/supplier data, not human patient data. There is no mention of country of origin for the studies, but the NTP study suggests US involvement for those specific studies.

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

Since this is not a human clinical study with a "test set" of patient cases requiring expert interpretation for ground truth, this information is not applicable. The "ground truth" for the laboratory tests was derived from physical measurements (temperature, concentration, freeze time) or established scientific methods (cytotoxicity assays, toxicology studies).

4. Adjudication Method for the Test Set

As there is no human-interpreted test set for this device, an adjudication method is not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, What was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance?

This is not an AI/CAD device. No MRMC study was performed, and this question is not applicable.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is not an algorithm-based device. No standalone performance study of an algorithm was done, and this question is not applicable.

7. The Type of Ground Truth Used

The "ground truth" in this context refers to the verifiable outcomes or measurements from the laboratory and pre-clinical studies:

• Quantitative Measurements: Applicator temperature (-50 °C), freeze times (1.31s, 1.99s), DME concentration (0.37 mg/ml), stated exposure limits (1000 ppm).
• Standardized Assay Results: Biocompatibility (non-lysic via ISO 10993:5), chemical residuals (none detected).
• Toxicological Study Endpoints: Acute toxicity (no acute toxicity in animal models/bacteria, "not acutely toxic" ranking), developmental toxicity (no significant toxic effect in animal models).
• Comparative Assessment: Functional similarity to predicate devices based on phantom skin model behavior.

8. The Sample Size for the Training Set

This device did not involve machine learning or AI; therefore, there is no "training set." All reported studies are for performance evaluation or characterization.

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

As there is no training set, this question is not applicable.

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Wart Freeze is indicated for the removal of common and plantar. The wart remover product is intended to be used in adults and children 4 years of age and over.

Wart Freeze is an over the counter cryosurgical product to remove common and plantar warts. The device consists of the following: Pressurized canister with the cryogen liquid dimethyl ether (DME), a dose valve which expels a specific quantity of the cryogen onto the wart, a polypropylene reusable applicator, 70% alcohol disposable cleansing swabs, Protective plasters (bandages).

The provided text describes a 510(k) Pre-market Notification for the "Wart Freeze" device. This is a submission to demonstrate substantial equivalence to previously cleared devices, not typically a full clinical study with acceptance criteria and performance metrics in the way a novel AI/software medical device would be.

Therefore, many of the requested elements for a detailed AI/software device study (such as MRMC studies, sample sizes for training/test sets, expert qualifications for ground truth establishment, etc.) are not applicable or not provided in this type of regulatory document.

However, I can extract information related to the device's pre-clinical testing, which serves as a form of "acceptance criteria" and "study" for this specific type of device.

Here's the breakdown based on the provided text:

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

Since this is a traditional 510(k) for a cryosurgical device, the "acceptance criteria" are not reported as specific numerical performance metrics (like sensitivity, specificity) but rather as successful completion of various functionality and safety tests demonstrating equivalence to predicate devices. The performance is "reported" as supporting the safety and effectiveness.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not explicitly stated for each test. For the "phantom skin test model," no sample size (number of tests or phantoms) is provided. No human subjects test set is mentioned.
• Data Provenance: Not explicitly stated. The manufacturer is Koninklijke Utermöhlen NV, located in the Netherlands. The 510(k) submission was made to the FDA in the USA. Given the nature of pre-clinical bench testing, the data would likely originate from laboratory settings where the tests were performed.
• Retrospective/Prospective: These pre-clinical tests are prospective in nature, as they are specifically conducted to evaluate the device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. This is a physical device undergoing pre-clinical bench and lab tests. There is no mention of human experts establishing "ground truth" for a test set in the context of diagnostic accuracy, image interpretation, or clinical outcomes. The "ground truth" for these tests would be objective measurements (e.g., temperature readings, concentrations, visual inspection for clarity of labels).

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

• Not applicable. Adjudication methods like 2+1 or 3+1 typically apply to clinical studies where multiple experts evaluate ambiguous cases or determine ground truth in a consensus-driven manner for diagnostic accuracy studies. This document describes bench and lab testing of a physical device.

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 is a cryosurgical device for wart removal, not an AI/software device. No MRMC study or AI assistance is mentioned.

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

• Not applicable. This is a physical cryosurgical device, not an algorithm.

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

• The "ground truth" for the pre-clinical tests varied by test type:
  • Comparative testing: Performance against predicate devices on a phantom skin model.
  • Temperature test: Direct measurement of temperature.
  • Dose technique test: Measurement of freeze time and assessment of "effectiveness" (likely through simulated application or efficacy on phantom models).
  • DME concentration: Chemical analysis.
  • Biocompatibility/Safety: Standardized ISO or similar biocompatibility tests for materials and chemical component analysis for safety.
  • Label comprehension: Survey results on public understanding of the instructions.

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device that requires a training set.

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

• Not applicable. This is not an AI/machine learning device.

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