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The product is indicated for the removal of the following skin lesions:

• Verrucae plantaris
• Verrucae Plana
• Verrucae vulgaris
• Mollescum contagiosum
• Skin tags
• = Actinic keratosis
• Genital warts "
• Lentigo
• । Seborrhoeic Keratosis

The product is a portable cryosurqery system which is prescription only intended for medical professionals. It is indicated for removal of skin lesions. The product is comprised of a dispenser (canister) containing a cryogen (cryoliquid) which freezes the lesion. It is packaged with a box of single-use foam-sticks (buds). The foam-stick is placed in the front of the dispenser into the opening under the applicator cap. The applicator button is pressed to dispel cryogen on the foamstick (bud). The foam-stick is applied to the skin lesion for the designated time to freeze the skin lesion.

This document is a 510(k) premarket notification for the Utermöhlen Cryo Professional device. It is a correspondence from the FDA confirming the device's substantial equivalence to previously marketed predicate devices.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

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

Based on the provided text, there are no specific quantitative acceptance criteria or precise performance metrics reported in a table format. The performance data section broadly states:

The text indicates that "Based on the performance testing the product is equivalent to the predicate." However, it does not provide the specific numerical targets or results of these tests that would typically be found in a detailed study report.

2. Sample size used for the test set and the data provenance

The document does not specify the sample size used for any of the performance tests. There is no information regarding the data provenance (e.g., country of origin, retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document does not mention the use of experts to establish a ground truth for a test set. The performance testing described relates to device functionality and biocompatibility, not diagnostic or treatment efficacy evaluated against expert consensus.

4. Adjudication method for the test set

There is no mention of an adjudication method, as the tests described are for device functionality and biocompatibility, not for subjective evaluation requiring adjudication.

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 such study was conducted or reported. This device is a cryosurgical unit, not an AI-assisted diagnostic or treatment system involving human readers.

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

This question is not applicable to the Utermöhlen Cryo Professional device, as it is a physical medical device (cryosurgical unit) and not an algorithm or AI system.

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

The concept of "ground truth" as typically used in AI or diagnostic device evaluations is not directly applicable here. The "ground truth" for the performance tests would be the established engineering and biological standards for functionality (e.g., no leakage, accurate temperature reading) and biocompatibility (e.g., no adverse biological reactions as per ISO 10993).

8. The sample size for the training set

This question is not applicable, as the device is a physical cryosurgical unit and does not involve AI or machine learning algorithms that require a training set.

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

This question is not applicable for the reasons stated in point 8.

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