(435 days)
Wart Freeze is indicated for the removal of common and plantar. The wart remover product is intended to be used in adults and children 4 years of age and over.
Wart Freeze is an over the counter cryosurgical product to remove common and plantar warts. The device consists of the following: Pressurized canister with the cryogen liquid dimethyl ether (DME), a dose valve which expels a specific quantity of the cryogen onto the wart, a polypropylene reusable applicator, 70% alcohol disposable cleansing swabs, Protective plasters (bandages).
The provided text describes a 510(k) Pre-market Notification for the "Wart Freeze" device. This is a submission to demonstrate substantial equivalence to previously cleared devices, not typically a full clinical study with acceptance criteria and performance metrics in the way a novel AI/software medical device would be.
Therefore, many of the requested elements for a detailed AI/software device study (such as MRMC studies, sample sizes for training/test sets, expert qualifications for ground truth establishment, etc.) are not applicable or not provided in this type of regulatory document.
However, I can extract information related to the device's pre-clinical testing, which serves as a form of "acceptance criteria" and "study" for this specific type of device.
Here's the breakdown based on the provided text:
1. A table of acceptance criteria and the reported device performance
Since this is a traditional 510(k) for a cryosurgical device, the "acceptance criteria" are not reported as specific numerical performance metrics (like sensitivity, specificity) but rather as successful completion of various functionality and safety tests demonstrating equivalence to predicate devices. The performance is "reported" as supporting the safety and effectiveness.
| Acceptance Criteria (What was tested) | Reported Device Performance (Outcome) |
|---|---|
| Comparative testing with predicate devices using a phantom skin model | Supports safety and effectiveness; suggests similar performance to predicates. |
| Applicator temperature test | Successfully determined the degree of cold generated by the cryogen on the applicator. |
| Dose technique test (dispensing freeze time) | Determined dispensing freeze time for two potential techniques; subsequent testing showed no difference in effectiveness between techniques. |
| Maximum allowable concentration of DME | Successfully determined. |
| Biocompatibility testing (cryogen & applicator material) | Determined safety of cryogen and applicator material. |
| Safety test (chemical residuals, leachable/degradable components) | Successfully identified any potential chemical residuals. |
| Label comprehension study | Ensured instructions for use and package label were clear and understandable for safe and effective use. |
2. Sample sized 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 explicitly stated for each test. For the "phantom skin test model," no sample size (number of tests or phantoms) is provided. No human subjects test set is mentioned.
- Data Provenance: Not explicitly stated. The manufacturer is Koninklijke Utermöhlen NV, located in the Netherlands. The 510(k) submission was made to the FDA in the USA. Given the nature of pre-clinical bench testing, the data would likely originate from laboratory settings where the tests were performed.
- Retrospective/Prospective: These pre-clinical tests are prospective in nature, as they are specifically conducted to evaluate the device.
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)
- Not applicable. This is a physical device undergoing pre-clinical bench and lab tests. There is no mention of human experts establishing "ground truth" for a test set in the context of diagnostic accuracy, image interpretation, or clinical outcomes. The "ground truth" for these tests would be objective measurements (e.g., temperature readings, concentrations, visual inspection for clarity of labels).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods like 2+1 or 3+1 typically apply to clinical studies where multiple experts evaluate ambiguous cases or determine ground truth in a consensus-driven manner for diagnostic accuracy studies. This document describes bench and lab testing of a physical 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
- Not applicable. This is a cryosurgical device for wart removal, not an AI/software device. No MRMC study or AI assistance is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical cryosurgical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the pre-clinical tests varied by test type:
- Comparative testing: Performance against predicate devices on a phantom skin model.
- Temperature test: Direct measurement of temperature.
- Dose technique test: Measurement of freeze time and assessment of "effectiveness" (likely through simulated application or efficacy on phantom models).
- DME concentration: Chemical analysis.
- Biocompatibility/Safety: Standardized ISO or similar biocompatibility tests for materials and chemical component analysis for safety.
- Label comprehension: Survey results on public understanding of the instructions.
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/machine learning 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.