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Dr. Scholl's® Dual Action Freeze Away™ Wart Remover is indicated for the overthe-counter removal of common and plantar warts.
For the removal of common and plantar warts.

Dr. Scholl's® Dual Action Freeze Away™ Wart Remover is a cryosurgical system for the over-the-counter removal of common and plantar warts. The device consists of the following:
a. Pressurized canister with a cryogen mixture of liquid dimethyl ether and propane
b. Salicylic Acid Liquid Wart Remover
c. Reusable activator that releases the cryogen into the applicators
d. Disposable applicators
e. Cushions
f. Information booklet

Here's an analysis of the provided text regarding the Dr. Scholl's® Dual Action Freeze Away™ Wart Remover, structured according to your request.

Please note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than independent performance claims against specific acceptance criteria for a novel device. Therefore, some of your requested information (e.g., specific acceptance criteria for efficacy, comparative effectiveness study with human readers improving with AI, sample size for training set, how training GT was established) is not present in this type of regulatory submission and cannot be extracted from this document.

Acceptance Criteria and Reported Device Performance

The core of this 510(k) submission is to demonstrate substantial equivalence to existing predicate devices. Therefore, the "acceptance criteria" are generally aligned with the performance and safety characteristics of the predicate devices. The device's performance is reported in comparison to these benchmarks.

Study Information

1. Sample size used for the test set and the data provenance:

   • Actual Use Study: 51 consumers.
   • Data Provenance: The document does not explicitly state the country of origin, but given it's a US FDA submission by a US company, it's highly likely the study was conducted in the United States. The study appears to be prospective as it involved consumers actively using the device under self-treatment conditions.
   • Label Comprehension Study: Sample size not specified, but this study preceded the Actual Use Study involving 51 consumers.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable/Not provided in this document. The "Actual Use Study" observed consumer comprehension and safe use, not the efficacy of wart removal itself, which is generally established through clinical trials (which this document is not). The efficacy of the active ingredients (cryotherapy and salicylic acid) is supported by existing predicate devices and regulations (21 CFR 358).

3. Adjudication method for the test set:

   • Not applicable/Not provided. The "Actual Use Study" focused on consumer comprehension and ability to follow instructions for safe use, not on outcome adjudication by experts.

4. 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:

   • No. This is a medical device for wart removal, not an AI-assisted diagnostic or interpretive system. Therefore, MRMC studies are not relevant.

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

   • No. This is a physical medical device, not a standalone algorithm.

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

   • For physical/chemical characteristics (temperature, composition): Direct measurement and chemical analysis.
   • For biocompatibility: Results from standard ISO 10993 testing.
   • For efficacy/safety of active ingredients (cryogen + salicylic acid): Referenced to the established safety and efficacy of predicate devices and FDA regulations (21 CFR 358 Subpart B, Final Rule for Wart Remover Drug Products). This could be considered "regulatory precedent" rather than a newly established ground truth for this specific device.
   • For "Ease of Use/Label Comprehension": The "ground truth" was whether consumers could correctly understand and apply the instructions safely and effectively for self-treatment in a naturalistic setting. This would be observed behavioral data from the Actual Use Study.

7. The sample size for the training set:

   • Not applicable. This device is not an AI/machine learning product and therefore does not have a "training set" in that context.

8. How the ground truth for the training set was established:

   • Not applicable, as there is no training set for an AI/ML algorithm.

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For the over-the-counter removal of common warts and plantar warts on the bottom of the foot.

Dr. Scholl's Freeze Away Wart Remover is a cryosurgical system for the over-thecounter removal of common warts and plantar warts on the bottom of the foot. The device consists of the following:

• Pressurized canister with a cryogen mixture of liquid dimethyl ether and propane
• Reusable activator that releases the cryogen into the applicators
• Disposable applicators
• Information booklet

The Dr. Scholl's Freeze Away Wart Remover is a cryosurgical system for the over-the-counter removal of common warts and plantar warts. The device was evaluated for substantial equivalence to predicate devices, namely the Wartner Wart Removal System (K011708) and the Histofreezer Wart Removal System (K023487, K924114).

The acceptance criteria for this device are primarily based on demonstrating substantial equivalence to its predicate devices in terms of technological characteristics, safety, and effectiveness. A formal study report with detailed numerical acceptance criteria and a corresponding performance report is not provided in the given text. Instead, the submission relies on direct comparisons to the predicate devices and general statements about the device's performance.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Since explicit numerical acceptance criteria are not presented in the document, the table below is constructed based on the comparisons made to the predicate devices, indicating what was deemed "similar" or "sufficient."

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

The provided text does not include information about any clinical studies or sample sizes for a "test set" in the traditional sense (e.g., patient data). The evaluation appears to be based on laboratory testing of the device's physical characteristics (temperature, duration, cryogen composition) and comparisons to established predicate devices. There is no mention of data provenance (e.g., country of origin, retrospective/prospective).

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable or provided in the given text. The "ground truth" for this type of submission is likely derived from established scientific principles for cryotherapy and the performance characteristics of previously cleared predicate devices, rather than expert consensus on individual cases.

4. Adjudication Method

This information is not applicable or provided as there is no mention of a human-read or human-interpreted test set requiring adjudication.

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

No MRMC comparative effectiveness study was done as this approval is for a physical device (cryosurgical wart remover) rather than an AI-powered diagnostic or interpretive tool. There is no mention of human readers or AI assistance in this context.

6. Standalone Performance Study (Algorithm Only)

Not applicable. This device is a physical product, not an algorithm. Therefore, a standalone algorithm performance study was not conducted. The performance described relates to the physical properties and efficacy of the cryosurgical process itself.

7. Type of Ground Truth Used

The "ground truth" for this submission primarily relies on:

• Physical and Chemical Properties: Laboratory measurements of temperature, duration, and cryogen composition.
• Established Efficacy of Cryotherapy: The underlying principle that cryotherapy is an effective method for wart removal (as demonstrated by the predicate devices).
• Predicate Device Performance: The demonstrated safety and effectiveness of the Wartner and Histofreezer devices in removing common and plantar warts.

8. Sample Size for the Training Set

There is no mention of a training set as this device does not involve machine learning or AI models that require data for training.

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

Since there is no training set, this information is not applicable.

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