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The Advanced Cryo Wart Remover is designed as an over-the-counter (OTC) self-care device indicated for adults and children from the age of four years and older for the treatment of common and plantar warts.

The Advanced Cryo Wart Remover is an over-the-counter (OTC) cryotherapy device designed for the treatment of common and plantar warts. The device includes:

• A 15 mL / 0.51 oz pressurized aerosol canister containing a freezing agent (1,1-Difluoroethane, Propane, and Isopentane).
• A metal tip that applies the cryogen directly to the wart
• Detailed instructions, including illustrated descriptions.
  To activate the product, the lay user must, while holding the device facing downward, press the side buttons firmly five times in a row. Apply the cold metal tip for 20 seconds on warts located on the hands, tops of feet, and toes. Apply for 40 seconds on plantar warts in areas with thicker or calloused skin.
  The device is non-sterile, reusable, and intended for home use by laypersons. No special training or sterilization is required for operation.

The provided text is a 510(k) premarket notification for the "Advanced Cryo Wart Remover." It describes the device, its intended use, and the non-clinical performance data used to demonstrate substantial equivalence to predicate devices. However, this document does not contain information about a study that establishes acceptance criteria for performance metrics (e.g., sensitivity, specificity, accuracy) or the results of such a study.

The document details:

• Non-clinical Performance Data (Section 9):
  • Biocompatibility Testing (ISO 10993 series)
  • Shelf Life Testing (ASTM D3090-72)
  • Transportation Testing (ASTM D4169)
  • Bench Testing (comparative thermal performance, freeze temperature extremes, plateau, and duration)
  • Label and IFU Comprehension Study (Flesch test)
  • Human Factors Study (usability study compliant with EN ISO 8317:2004, secondary usability study on timing, self-assessment study on wart identification)

These studies are primarily focused on safety, usability, and the physical characteristics of the device (such as its ability to freeze at certain temperatures or its shelf life). They do not involve a clinical study with a test set, ground truth experts, or metrics like sensitivity/specificity for wart removal effectiveness. The "self assessment study" mentioned under Human Factors is related to label comprehension, not the device's efficacy.

Therefore, I cannot provide the requested table or answer the questions related to clinical performance, as the provided text does not contain that information. The 510(k) pathway for this device relied on demonstrating substantial equivalence primarily through non-clinical performance data and comparison to legally marketed predicate devices, rather than a new clinical efficacy study with performance acceptance criteria like those often seen for AI/ML-driven devices.

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