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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.

• 3-long presses resulted in a freeze time of 1.99 seconds. |
  | - Maximum acceptable concentration of DME administered | - Maximum acceptable concentration of DME administered was 0.37 mg/ml during both dose techniques, ensured by a safety (dose) valve. |
  | Biocompatibility | |
  | - Applicator material safety | - Biocompatibility testing (ISO 10993:5 Tests for in vitro cytotoxicity) performed on the polypropylene applicator in contact with cryogen.
• The applicator material was found to be non-lysic. |
  | Chemical Residuals/Leachables | |
  | - Absence of harmful chemical residuals/leachables | - Laboratory testing concluded no chemical residuals in dimethylether/polypropylene extracts, indicating no leachable components between the applicator and cryogen. |
  | Cryogen Safety (Dimethylether - DME) | |
  | - Non-toxic by inhalation | - DME inhalation studies (by suppliers), including US National Toxicological Programme (NTP) acute toxicity studies (LC50) on mouse and rabbit.
• Concluded DME did not produce acute toxicity in animal models or bacteria (Ames Salmonella Typhimiurium).
• Developmental toxicity studies in animal models showed no significant toxic effect on mice or rabbit pups.
• DME received a ranking of "not acutely toxic" by the NTT.
• Current exposure limits (1000 ppm or 0.1% DME for 8-hour daily life-time exposures) are significantly higher than typical consumer product exposures (~100 ppm for short periods

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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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