(261 days)
Wartner Wart Removal System is intended for the over-the-counter treatment of common warts.
Wartner Wart Removal System is indicated for OTC treatment of common warts.
Wartner Wart Removal System is intended for the treatment of common warts.
Wartner Wart Removal System is a cryosurgical system for the treatment of warts. It consists of
- A canister filled with 35 ml of a liquid mixture of the compressed gases . dimethyl ether and propane. This gas mixture does not harm the ozone layer, and has a four-year shelf life.
- . Ten foam applicators
- . An applicator stick/key for holding a foam applicator, required to dispense the liquid to the applicator, and held by the person during treatment
- An illustrated description of how to use the product .
The provided text describes the Wartner Wart Removal System and focuses on its substantial equivalence to a predicate device rather than presenting a detailed study with specific acceptance criteria and performance metrics for the new device. Therefore, many of the requested elements (like sample size for test sets, number of experts for ground truth, MRMC study results, etc.) are not available in this document.
However, based on the information provided, here's what can be extracted and inferred:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Safety and Effectiveness Equivalence: Functionally and operationally equivalent to predicate device. | The device is concluded to be safe and effective for its intended use and substantially equivalent to the primary predicate device (Wartner Wart Removal System for prescription use). It is also substantially equivalent in intended use, safety, and labeling to several labeling predicate devices. |
| Applicator Temperature (after saturation): Optimal for wart treatment. | Average temperature of the applicator surface after saturation is -56.4° C. |
| Applicator Effectiveness Duration: Maintain temperature below a certain threshold. | Foam applicator maintains a temperature of less than -50° C for up to five minutes. |
| Cryogen Composition: Same as predicate device. | Cryogen is a mixture of dimethylether and propane, identical to the predicate device. |
| Biocompatibility: Materials used are safe. | Cryogen and foam material (S616) are the same as the predicate device and well-characterized in published literature. |
| Safety Valve Functionality: Ensures safe operation. | Design incorporates a safety valve that cannot be actuated unless the foam applicator and holder are in place, identical to the predicate device. |
| Labeling Adequacy: Clear directions for use and safety, and information for self-diagnosis. | Labeling developed to ensure adequate directions for use, safety, self-diagnosis information, and instructions to contact a doctor if needed. Safety and warning statements are essentially similar to predicate devices. |
Missing Information for this Section: The document does not explicitly state quantitative "acceptance criteria" for clinical effectiveness (e.g., "X% of warts removed within Y weeks"). The focus is heavily on equivalence to the predicate.
2. Sample Size used for the Test Set and Data Provenance
- Sample Size: Not specified. The document describes laboratory testing and comparisons to predicate device characteristics, but no human clinical trial involving a "test set" of patients is detailed.
- Data Provenance: The document describes laboratory testing. It does not mention clinical data or its provenance (e.g., country of origin, retrospective/prospective).
3. Number of Experts used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Not applicable as no clinical test set requiring expert-established ground truth is described. The safety and effectiveness claims are based on substantial equivalence to a predicate device and laboratory testing.
4. Adjudication Method for the Test Set
- Not applicable as no clinical test set requiring adjudication is described.
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 device is a cryosurgical wart removal system, not an AI or imaging diagnostic device. Therefore, no MRMC study or AI assistance is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable as this is a physical medical device, not an algorithm.
7. The type of ground truth used
- The "ground truth" for the claims in this submission appears to be derived from:
- Predicate Device Characteristics: Comparison of physical and chemical properties, design features, and intended use with the legally marketed predicate device.
- Laboratory Measurements: Explicit measurements of temperature (-56.4°C applicator surface,
§ 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.