(430 days)
The Freeze 'n Clear Skin Clinic for Warts and Skin Tags product is intended for the OTC treatment of common warts, plantar warts, and skin tags.
The Freeze 'n Clear Skin Clinic for Warts and Skin Tags product utilizes extreme cold to facilitate the removal of warts and skin tags by freezing. Each kit contains a container of cryogen gas, foam applicators, tweezers and instructions for use. The device is for OTC use and utilizes a combination of dimethyl ether, propane and isobutane delivered from the canister into a foam applicator which acts as a reservoir for the cryogen gas. The gas rapidly evaporates and cools the applicator to approximately -55°C. The applicator is then placed against the wart or skin tag for 40 seconds which freezes the targeted tissue. The frozen skin tag or wart falls away over time and new epidermis grows in its place. One to four treatments with intervals of two weeks may be required.
The provided text describes the Freeze 'n Clear Skin Clinic for Warts and Skin Tags device (K211099), a cryosurgical unit intended for the over-the-counter (OTC) treatment of common warts, plantar warts, and skin tags.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria in a table format for performance metrics. Instead, it focuses on demonstrating substantial equivalence to predicate devices and fulfilling safety and usability requirements for an OTC product.
However, based on the performance data section, implicit criteria and reported performance can be inferred:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility: Device materials meet safety standards. | Passed cytotoxicity, sensitivity, irritation tests according to FDA's biocompatibility 2020 guidance and ISO 10993. |
| Cryogenic Efficacy (Temperature): Device achieves equivalent freezing temperatures to predicate. | Bench testing demonstrated equivalent temperatures to the Histofreezer Professional predicate device. |
| Cryogenic Efficacy (Cell Destruction): Device is equivalent in ability to freeze and destroy target cells as predicate. | Bench testing using an in vitro model demonstrated equivalence in freezing and destroying target cells compared to Histofreezer Professional. |
| Self-Diagnosis/Self-Selection: Majority of users can accurately self-diagnose and determine if the product is suitable for their condition. | Clinical study and human factors usability study demonstrated the majority of subjects were able to self-diagnose and self-select for the product. |
| Label Comprehension: Majority of users can understand the product directions. | Clinical study and human factors usability study demonstrated the majority of subjects understood the directions. |
| Appropriate Use: Majority of users can appropriately use the product as instructed. | Clinical study and human factors usability study demonstrated the majority of subjects appropriately used the product. |
| Safety (Post-Market): Low incidence of complaints and adverse events in existing markets. | Historical data showed a low number of complaints and adverse events outside the US with the Freeze 'n Clear product for warts or skin tags. |
2. Sample size used for the test set and the data provenance
- Clinical Study Test Set: Over 300 subjects.
- Data Provenance: Conducted at 3 US dermatology offices (prospective clinical study). Historical data on complaints and adverse events was also considered, which would be retrospective data from outside the US.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not specify the number or qualifications of experts used to establish ground truth for the clinical study's subjects (e.g., confirming the nature of warts or skin tags). It mentions that the study was performed at dermatology offices, implying clinical oversight, but details on expert review for ground truth are not provided. For the "self-diagnosis" aspect, the ground truth would presumably be the dermatologists' diagnoses compared to the subjects' self-diagnoses.
4. Adjudication method for the test set
The document does not describe a specific adjudication method (e.g., 2+1, 3+1). It states a clinical study was performed at dermatology offices, which implies physician oversight and potentially consensus on diagnoses if multiple practitioners were involved, but details are not given.
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, an MRMC comparative effectiveness study was not done. This device is a cryosurgical unit, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, aspects of "standalone" performance were assessed through bench testing.
- Bench Testing (Temperature): Compared temperatures attained by the subject device and a predicate device.
- Bench Testing (Cell Destruction): Used an in vitro model to compare the ability of the subject device and a predicate device to freeze and destroy target cells.
7. The type of ground truth used
- Biocompatibility: Established by adherence to ISO 10993 standards.
- Cryogenic Efficacy (Bench Testing): Ground truth was based on objective physical measurements (temperature) and in vitro cell destruction models.
- Clinical Study: Ground truth for self-diagnosis and self-selection would likely be the dermatologists' clinical diagnoses of warts and skin tags, against which subject self-assessments were compared. Usability and label comprehension ground truth would be based on subjects' ability to follow instructions and correctly operate the device.
- Post-Market Safety: Ground truth derived from historical complaint and adverse event data.
8. The sample size for the training set
The document does not refer to a "training set" as this device is a physical cryosurgical unit and not an AI/machine learning algorithm requiring a distinct training phase.
9. How the ground truth for the training set was established
Not applicable, as there is no training set in the context of this device.
§ 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.