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The CryoFreeze Wart and Skin Tag Remover is intended for use in the over-the-counter treatment of common warts and plantar warts in adults and children age 4 years or older and over-the-counter treatment of skin tags in adults age 22 years or older.

The CryoFreeze Wart and Skin Taq Remover is an over-the-counter (OTC) cryotherapy device designed for the treatment of common, plantar warts, and skin tags. The device includes:

• A pressurized aerosol canister filled with a liquid mixture of the compressed gases dimethyl ether, propane, and isobutane
• Applicator swabs
• Detailed instructions, including illustrated descriptions

To use the device, the user must insert an applicator swab into the actuator, saturate the swab with cryogen, and apply the foam tip of the swab directly onto the lesion, holding it in place for 40 seconds. After removal, the frozen tissue will appear white and begin to thaw, typically taking 20-40 seconds.

The device is non-sterile and intended for home use by laypersons. No special training or sterilization is required for operation.

The provided document is a 510(k) summary for the CryoFreeze Wart and Skin Tag Remover, which is a cryosurgical unit. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed clinical study results with acceptance criteria in the same way a PMA (Pre-Market Approval) or de novo submission might.

Therefore, the document does not contain the detailed information required to fully answer all aspects of your request, specifically regarding clinical studies, sample sizes, expert qualifications, or ground truth establishment relevant to AI/algorithm performance. The device described is a physical medical device, not an AI/software as a medical device (SaMD).

Here's an analysis based on the available information:

1. A table of acceptance criteria and the reported device performance:

The document does not explicitly state "acceptance criteria" in the traditional sense of a clinical trial for performance outcomes (e.g., cure rates, recurrence). Instead, substantial equivalence is demonstrated through technological comparison and non-clinical performance testing against a reference device.

• Use (OTC)
• Mechanism of action (extreme cold destroys tissue)
• Cryogen material (dimethyl ether, propane, isobutane)
• Freeze temperature (-55°C)
• Design (canister, applicators, tweezers)
• Treatment procedure
• Storage & safety conditions
• Disposal
• Defined operators (consumer use) |
  | Output Temperature of Cryogen | Equivalent to reference device (Verruca-Freeze H) | Confirmed equivalent to reference device |
  | Freeze Charge Hold Time | Equivalent to reference device (Verruca-Freeze H) | Confirmed equivalent to reference device |
  | Visual Confirmation of Ice Ball | Equivalent to reference device (Verruca-Freeze H) | Confirmed equivalent to reference device |

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Sample Size for Test Set: Not applicable in the context of this 510(k) for a physical cryosurgical device. The document mentions "comparative performance testing against the reference device," but it does not specify sample sizes for these non-clinical tests (e.g., how many times temperature was measured, or how many freeze cycles were observed).
• Data Provenance: Not specified, but generally, non-clinical tests for 510(k) devices are conducted by the manufacturer or a contract research organization.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• This information is not provided because the device is a physical cryosurgical unit, and the testing described is non-clinical performance testing rather than clinical evaluation against an expert-determined ground truth for diagnostic accuracy, for example.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable/Not provided as the testing described is non-clinical performance testing, not a clinical trial requiring adjudication of patient outcomes or diagnostic readings by experts.

5. 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 MRMC study was done. This device is a direct-to-consumer physical cryosurgical tool, not an AI or imaging device that would involve human readers or AI assistance.

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

• No standalone algorithm performance study was done. This device does not involve an algorithm.

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

• For the non-clinical performance tests, the "ground truth" would be the measured physical properties (e.g., temperature) as determined by calibrated instruments, and visual observations (e.g., ice ball formation). This is not a "ground truth" in the clinical or diagnostic sense.

8. The sample size for the training set:

• Not applicable. This device is not an AI/ML product and does not have a "training set."

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

• Not applicable. This device is not an AI/ML product and does not have a "training set."

In summary, the provided 510(k) letter and summary establish substantial equivalence for the CryoFreeze Wart and Skin Tag Remover based on its technological characteristics and non-clinical performance being comparable to previously cleared predicate and reference devices. It does not involve AI or clinical studies with expert-adjudicated ground truth as would be relevant for software/AI-based medical devices.

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