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The Skin Clinic Freeze Point product is intended for the treatment of common warts, plantar warts, and skin tags by OTC consumers. Treat skin tags in adults age 22 years or older

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This 510(k) clearance letter details the clearance of a medical device, "Skin Clinic Freeze Point for Warts and Skin Tags," which is a cryosurgical unit. However, the provided document does not contain any information about the acceptance criteria or the study that proves the device meets the acceptance criteria.

The 510(k) process is primarily focused on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than requiring extensive clinical trials to prove efficacy and safety in the same way a PMA (Premarket Approval) application would. While a 510(k) submission does include performance data, this particular clearance letter only states that the device is substantially equivalent and provides regulatory information, such as:

• Device Name: Skin Clinic Freeze Point for Warts and Skin Tags
• Regulation Number: 21 CFR 878.4350
• Regulation Name: Cryosurgical Unit And Accessories
• Regulatory Class: Class II
• Product Code: GEH
• Indications for Use: Treatment of common warts, plantar warts, and skin tags by OTC consumers; treat skin tags in adults age 22 years or older.
• Type of Use: Over-The-Counter Use

Therefore, I cannot provide the requested information regarding acceptance criteria and study details based solely on this document.

To answer your prompt, I would need a different type of document, such as a summary of safety and effectiveness data (SSED) or a detailed study report that would typically be part of a 510(k) submission but is not included in the clearance letter itself.

Without that information, I cannot fill in the table or address the points about sample size, expert ground truth, adjudication, MRMC studies, standalone performance, training set details, or ground truth establishment.

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