(52 days)
The Skin Clinic Freeze Point product is intended for the treatment of common and plantar warts by OTC consumers. May be used with children 4 years of age or older under adult supervision.
The Skin Clinic Freeze Point device utilizes extreme cold to facilitate the removal of warts and by freezing. Each kit contains a container of cryogen gas in a plastic holder and instructions for use. The device is for OTC use and utilizes difluoroethane cryogen delivered from the canister into a foam wrapped tip which acts as a reservoir for the cryogen gas. The gas rapidly evaporates and cools the applicator to as low as -50°C. The applicator is then placed against the wart for up to 40 seconds which freezes the targeted tissue. The frozen wart falls away over time and new epidermis grows in its place. One to four treatments with intervals of two weeks may be required.
This document describes the FDA's 510(k) clearance for the Skin Clinic Freeze Point device. However, it does not contain the detailed information necessary to fully answer your request regarding acceptance criteria and the comprehensive study that proves the device meets those criteria, particularly for a medical device that relies on AI/ML or complex diagnostic capabilities.
The provided text focuses on demonstrating substantial equivalence to predicate devices for a cryosurgical unit, which is typically cleared based on bench testing (temperature comparison, cell destruction), biocompatibility, and human factors usability for an OTC product. It does not involve performance metrics or study designs typically associated with AI/ML devices or diagnostic accuracy studies (e.g., sensitivity, specificity, MRMC studies, detailed ground truth establishment, or specific acceptance criteria for algorithm performance).
Therefore, I cannot provide a complete answer with all the requested details (especially points 1, 2, 3, 4, 5, 6, 7, 8, 9) because the information is not present in this kind of 510(k) summary for this type of device.
However, I can extract what is provided and explain why other points are not applicable or present:
Based on the provided document for the Skin Clinic Freeze Point device:
1. A table of acceptance criteria and the reported device performance:
This 510(k) summary does not present specific quantitative acceptance criteria or detailed performance results in the format of a table as one would expect for a diagnostic or AI/ML device (e.g., sensitivity, specificity thresholds). Instead, "performance" is demonstrated by:
- Bench Testing:
- Acceptance Criteria (Implied): Temperatures attained by the Skin Clinic Freeze Point product are comparable to the Wartie and Freeze n Clear Skin Clinic predicate devices.
- Reported Performance: "Bench testing compared the temperatures attained by the Wartie and Freeze n Clear Skin Clinic predicate devices to the Skin Clinic Freeze Point product to demonstrate that they were comparable."
- Acceptance Criteria (Implied): Ability to freeze and destroy target cells is comparable to predicate devices.
- Reported Performance: "Additional bench testing using an in vitro method compared all the same products and showed they were comparable in their ability to freeze and destroy target cells."
- Biocompatibility:
- Acceptance Criteria (Implied): Meets the requirements of ISO 10993.
- Reported Performance: "product was tested for biocompatibility including cytotoxicity, sensitivity, irritation according to FDA's biocompatibility 2020 guidance and meets the requirements of ISO 10993."
- Human Factors Usability:
- Acceptance Criteria (Implied): Consumers can comprehend and understand the labeling and use of the product for OTC indication.
- Reported Performance: "The human factors usability testing evaluated consumers ability to comprehend and understand the labelling and use of the product."
2. Sample size used for the test set and the data provenance:
- Bench Testing: Not specified as "sample size" in the context of clinical data. It refers to a comparison of devices rather than patient data. Data provenance is implied to be laboratory testing.
- Human Factors Usability Study: The specific sample size for the usability study is not provided in this summary. Data provenance would be prospective usability testing with human participants.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not provided. This device is a cryosurgical unit, not a diagnostic device requiring expert interpretation for ground truth. Its performance is evaluated through physical characteristics (temperature, cell destruction) and user comprehension.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable / None specified. This concept is relevant for diagnostic accuracy studies involving multiple readers or assessors to establish a reference standard, which is not the primary mode of evaluation for this device.
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, not done. This is a physical device (cryosurgical unit), not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies and AI assistance are irrelevant to its evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device does not have an "algorithm" in the sense of AI/ML or image processing that performs standalone tasks.
7. The type of ground truth used:
- Bench Testing:
- Temperature Measurement: The "ground truth" would be the measured temperature of the applicator or the frozen tissue, compared against the predicate devices' performance.
- Cell Destruction: The "ground truth" would be the observed destruction of target cells in an in vitro model, compared against the predicate devices' performance.
- Human Factors Usability: The "ground truth" would be the observed user interactions and comprehension of instructions, typically assessed against pre-defined usability success criteria (e.g., successful task completion, correct answers to comprehension questions).
8. The sample size for the training set:
- Not applicable / Not provided. This device does not use a "training set" in the context of machine learning or algorithms. Its design and manufacturing are based on established engineering principles and safety standards for medical devices.
9. How the ground truth for the training set was established:
- Not applicable. See point 8.
Summary:
The provided 510(k) summary focuses on demonstrating substantial equivalence for a cryosurgical unit based on its physical characteristics, biocompatibility, and user-friendliness for over-the-counter use, not on complex diagnostic or AI-driven performance metrics. Therefore, many of the questions related to AI/ML device evaluation are not applicable or answered by this document.
§ 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.