(92 days)
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:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functionality (leakage) | Passed |
| Functionality (temperature probe testing) | Passed |
| Functionality (comparator functionality) | Passed |
| Biocompatibility (ISO 10993) | Passed |
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.
§ 878.4350 Cryosurgical unit and accessories.
(a)
Identification —(1)Cryosurgical unit with a liquid nitrogen cooled cryoprobe and accessories. A cryosurgical unit with a liquid nitrogen cooled cryoprobe and accessories is a device intended to destroy tissue during surgical procedures by applying extreme cold.(2)
Cryosurgical unit with a nitrous oxide cooled cryoprobe and accessories. A cryosurgical unit with a nitrous oxide cooled cryoprobe and accessories is a device intended to destroy tissue during surgical procedures, including urological applications, by applying extreme cold.(3)
Cryosurgical unit with a carbon dioxide cooled cryoprobe or a carbon dioxide dry ice applicator and accessories. A cryosurgical unit with a carbon dioxide cooled cryoprobe or a carbon dioxide dry ice applicator and accessories is a device intended to destroy tissue during surgical procedures by applying extreme cold. The device is intended to treat disease conditions such as tumors, skin cancers, acne scars, or hemangiomas (benign tumors consisting of newly formed blood vessels) and various benign or malignant gynecological conditions affecting vulvar, vaginal, or cervical tissue. The device is not intended for urological applications.(b)
Classification. Class II.