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Forwarts® is indicated for the treatment of warts on hands (common warts) and feet (plantar warts).

Forwarts® is a wart removal device that works by the principle of cryotherapy and is intended for the treatment of common and plantar warts. It delivers a precise cryogenic spray directly onto a wart or verruca which causes them to freeze and fall off the skin in approximately 10-14 days. The device consists of a pressurized aerosol can containing 35 ml dimethyl ether (DME). The aerosol can is held in a polypropylene shell (front and back). The front shell contains a distance holder for a safe and regulated application and a visor to point and limit the spray pattern. The translucent back shell contains a ridge for safe handling. The valve system will be extended by an actuator to point and minimize the spray pattern. Forwarts® is supplied with ten (10) protection patches per device to be placed around the wart prior to treatment to help prevent damage of healthy skin. Forwarts® is supplied non-sterile and not intended to be sterilized by the end user. The Forwarts® nozzle should be cleaned after each use with rubbing alcohol (70%).

The provided document describes the "Forwarts®" device, a cryosurgical unit for wart removal. Here's a breakdown of the acceptance criteria and the study information based on the text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to predicate devices rather than listing specific, quantified acceptance criteria with corresponding performance data in a direct tabular format. However, based on the non-clinical performance data section, we can infer the acceptance criteria and the device's reported performance against them.

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

The document does not explicitly state a sample size for the "test set" in the context of clinical trials or specific data points. The studies mentioned are:

• Biocompatibility: General testing per ISO 10993 standards. No specific sample size for a "test set" mentioned; likely refers to laboratory testing of materials.
• Shelf Life: Testing of device stability and functionality under simulated conditions. No specific sample size for a "test set" mentioned.
• Transportation Testing: Testing of the device in its final shipping configuration. No specific sample size for a "test set" mentioned.
• Bench Testing (Thermal Performance): Thermoelectric testing and simulated skin model. No specific sample size for a "test set" mentioned; likely refers to laboratory measurements.
• Self-selection / Label Comprehension Study: "Study subjects were provided with the Forwarts® labeling." No specific sample size provided, nor directly stated provenance (e.g., country of origin, retrospective/prospective).
• Human Factors Study: "Formative Study... included Simulated Use Testing... and a semi-guided interview with test subjects. A Human Factor Validation Test was then performed." No specific sample size provided, nor directly stated provenance.

It is important to note that this submission is a 510(k) premarket notification, which relies on demonstrating substantial equivalence to legally marketed predicate devices rather than requiring extensive clinical trials with large test sets typically seen for PMA submissions. The studies mentioned are primarily non-clinical or usability studies.

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

The document does not describe the use of experts to establish ground truth for any test sets. The studies mentioned (biocompatibility, shelf life, transportation, thermal performance, self-selection, human factors) do not typically involve expert consensus for ground truth in the way a diagnostic AI device would, where expert radiologists/pathologists review cases.

4. Adjudication Method for the Test Set:

No adjudication method is mentioned as there is no specific "test set" and ground truth establishment by experts as would be seen in a clinical trial for a diagnostic device.

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

No MRMC comparative effectiveness study was done. The device is a cryosurgical unit, not a diagnostic AI device that would typically involve human readers.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance):

This question is not applicable to the Forwarts® device, as it is a cryosurgical unit and not an algorithm or AI system.

7. Type of Ground Truth Used:

The "ground truth" for the various non-clinical and usability studies is inherent in the methodology:

• Biocompatibility: Established by adhering to ISO 10993 standards.
• Shelf Life: Determined by stability and functionality over time under simulated conditions.
• Transportation Testing: Demonstrated by maintaining package integrity and device functionality after simulated transport.
• Thermal Performance: Measured physical characteristics (temperature, duration, size of freeze spot) with comparative data against predicate devices.
• Self-selection / Label Comprehension: Success rate based on participant actions and comprehension during the study.
• Human Factors Study: Validation of safe usability based on observations during simulated use and interviews.

8. Sample Size for the Training Set:

This question is not applicable as the Forwarts® device is a physical cryosurgical unit and not an AI/ML algorithm that requires a training set.

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

This question is not applicable as the Forwarts® device is a physical cryosurgical unit and not an AI/ML algorithm that requires a training set.

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

The Compound W® Wart Removal System Dual Power is a cryosurgical system for the over-the-counter removal of common and plantar warts. Compound W® Wart Removal System Dual Power consists of the following:

• O Pressurized aerosol spray canister with a mixture of dimethyl ether and propane (K032271)
• o Reusable actuator/cap that releases the cryogen onto the disposable applicators
• Disposable foam applicators O
• Salicylic acid gel wart remover provided in a squeeze tube (in compliance with OTC O monograph 21 CFR 358 subpart B)
• O Comfort pads
• Instruction Leaflet o

This document is a 510(k) premarket notification for the "Compound W® Wart Removal System Dual Power." It primarily establishes substantial equivalence to a predicate device, rather than presenting a detailed study proving the device meets specific acceptance criteria in the context of clinical performance.

While the document details comparisons between the new device and a predicate device (Dr Scholl's® Dual Action Freeze Away™ Wart Remover) to demonstrate substantial equivalence, it does not contain information about:

1. A table of acceptance criteria and reported device performance: The document compares technical characteristics and indications for use, but there are no specific numerical acceptance criteria (e.g., success rates, cure rates) or corresponding performance data from a clinical study for the new device.
2. Sample size used for the test set and data provenance: No clinical test set data is provided.
3. Number of experts used to establish ground truth and their qualifications: Not applicable, as no clinical test set data is discussed.
4. Adjudication method: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: No such study is mentioned. The device is a direct-to-consumer product, not typically requiring comparative effectiveness studies against human readers for diagnostic tasks.
6. Standalone (algorithm only) performance: Not applicable, as this is a physical medical device, not an AI algorithm.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable, as this is a physical device, not an AI algorithm trained on data.
9. How ground truth for the training set was established: Not applicable.

However, based on the provided text, we can infer the "acceptance criteria" through the lens of "substantial equivalence" to the predicate device. The primary acceptance criterion for the FDA 510(k) pathway is that the new device is "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use and technological characteristics, or if it has different technological characteristics, it does not raise new questions of safety or effectiveness and is as safe and effective as the predicate device.

Here's an attempt to structure the answer based on the provided document, interpreting the "acceptance criteria" as meeting substantial equivalence to the predicate:

The provided document is a 510(k) premarket notification, which seeks to demonstrate substantial equivalence to a legally marketed predicate device rather than presenting a de novo clinical study with specific performance acceptance criteria. Therefore, the "acceptance criteria" are implied by the FDA's regulatory standard for 510(k) clearance, which means the device must be as safe and effective as a predicate device and not raise new questions of safety or effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance:
The document does not describe a clinical performance study with a test set. The basis for clearance is substantial equivalence to a predicate device based on comparison of characteristics and technological features.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable, as no clinical test set data is presented.

4. Adjudication method for the test set:
Not applicable, as no clinical test set data is presented.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
No, an MRMC comparative effectiveness study was not done or reported in this document. This type of study is typically conducted for diagnostic devices where human interpretation of images or signals is involved. The device is a therapeutic cryosurgical unit.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical medical device, not an AI algorithm.

7. The type of ground truth used:
Not applicable, as no clinical data with ground truth is discussed for the device's performance. The "ground truth" in the context of a 510(k) is effectively the established safety and effectiveness of the identified predicate device that the new device is compared against.

8. The sample size for the training set:
Not applicable, as this is a physical medical device, not an AI algorithm that requires 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 AI algorithm.

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