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Compound W® Skin Tag Remover is intended for the OTC treatment of skin tags in adults age 22 years or older.

Compound W® Skin Tag Remover is a cryogenic device intended to remove acrochordons (skin tags) via epidermal cryotherapy, destroying target epidermal cells by using extremely cold temperatures. The device contains a non-replaceable, non-refillable aluminum canister holding the gases dimethyl ether and propane. Activation of the device ejects a dose of the gases into a disposable polyurethane foam applicator tip, resulting in freezing of the applicator to approximately -30°C. The cold applicator tip is placed on the skin tag, thus destroying the target tissue. Each Compound W® Skin Tag Remover device is supplied in a paperboard carton with eight disposable tips, plastic tweezers, adhesive "Tag Target" skin-protecting discs, and an Instructions-for-Use leaflet.

The provided document is a 510(k) premarket notification from Medtech Products Inc. to the FDA for their product "Compound W Skin Tag Remover." It details the device's characteristics and compares it to a predicate device to demonstrate substantial equivalence.

Based on the information provided, here's a description of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Cryogenic Performance Study (in vitro): The document does not specify the exact sample size for the "product samples" tested. It only states "Product samples were tested."

  • Provenance: This was an in vitro experiment, meaning it was conducted in a lab setting, not on human subjects. The origin of the products themselves (Compound W device and predicate) would be from the respective manufacturers. There is no mention of country of origin for test data, but the submission is to the US FDA.
  • Retrospective/Prospective: This appears to be a prospective bench test designed specifically for this submission.

• Biocompatibility Testing: The document does not specify the sample size for the materials tested (canister, adhesive Tag Target discs).

  • Provenance: This is lab-based testing.
  • Retrospective/Prospective: This appears to be prospective lab testing.

• Human Factors Validation Testing:

  • Sample Size: 50 participant volunteers.
  • Data Provenance: The document states participants were from the "general population," including "15 intended users and 35 non-intended users." The location of this study (e.g., country, specific site) is not specified.
  • Retrospective/Prospective: This was a prospective usability study specifically conducted to validate the device's human factors.

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

• Cryogenic Performance: No external experts were used for ground truth establishment. The ground truth (temperature readings) was established directly by the measuring instrument (thermocouple sensor).
• Biocompatibility Testing: The ground truth for biocompatibility is established by the test results against the criteria of ISO 10993. This would typically be conducted by certified lab personnel, but "experts" in the sense of adjudicating human-generated data are not applicable here.
• Human Factors Validation Testing: No explicit mention of external experts establishing a "ground truth" for the test set. The study aimed to assess if users could safely and effectively use the device, and the findings are reported at a high level. Human factors studies are more about observing user interaction and identifying potential use errors rather than adjudicating a "truth" like a medical diagnosis. The "ground truth" here is the observed user behavior and the successful completion of tasks based on the product's design and labeling.

4. Adjudication Method for the Test Set

• Cryogenic Performance & Biocompatibility: Not applicable, as these were objective bench/lab tests with quantifiable outputs from measurements or standard protocols.
• Human Factors Validation Testing: The document does not describe a specific adjudication method like "2+1" or "3+1." Human factors studies involve direct observation, task analysis, and error collection. The assessment of whether the user interface "supports safe and effective use" would be based on the data collected during these observations and the analysis by the human factors specialists conducting the study.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, an MRMC comparative effectiveness study was not done. This type of study is specifically relevant for diagnostic imaging AI, where multiple readers interpret cases with and without AI assistance to measure improvement in diagnostic accuracy. The "Compound W Skin Tag Remover" is a cryogenic device for physical removal of skin tags, not a diagnostic imaging device. The studies focused on physical performance, biocompatibility, and usability.

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

• Not applicable in the context of an AI algorithm. This device does not contain an AI algorithm. Its "performance" is mechanical/chemical (freezing capacity) and user interface design. The cryogenic performance and biocompatibility tests can be considered "standalone" in the sense that they assess the device's physical properties independently of human interaction during the test, but this refers to the product's physical function, not an AI algorithm.

7. The Type of Ground Truth Used

• Cryogenic Performance: Objective physical measurement (temperature, in degrees Celsius) using a thermocouple sensor.
• Biocompatibility Testing: Results compared against established ISO 10993 standards and criteria for cytotoxicity, skin irritation, and sensitization.
• Human Factors Validation Testing: Observed user behavior, success/failure in task completion, and identification of use errors based on pre-defined criteria.

8. The Sample Size for the Training Set

• Not applicable. This device is a physical product (cryosurgical unit), not a machine learning or AI model. Therefore, there is no "training set" in the context of AI.

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

• Not applicable. As there is no AI/ML component, there is no training set or ground truth establishment for such a set.

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