(154 days)
The Histofreezer® Wart Removal System is indicated for over-the-counter treatment of common warts and plantar warts.
The Histofreezer® Wart Removal System is a cryosurgical system for the treatment of warts. It consists of: A canister filled with a liguid mixture of the compressed gases dimethyl ether, propane 0 and isobutane o Custom applicators O An illustrated description of how to use the product
The provided text does not contain information about specific acceptance criteria or a study designed to prove the device meets such criteria. The document is a 510(k) summary for the Histofreezer® Wart Removal System, which focuses on demonstrating substantial equivalence to a predicate device rather than conducting a new performance study with explicit acceptance criteria.
The main points of the document are:
- Device Name: Histofreezer® Wart Removal System
- Intended Use: Over-the-counter treatment of common warts and plantar warts.
- Basis for Equivalence: Substantial equivalence to the prescription Histofreezer® device (K911420, K924114, K971392) for the same indications, and commercial predicate devices (Wartner Wart Removal System, Compound W Gel, Clear Away Liquid, Clear Away One Step for Kids, Rite Aid Wart Liquid, Suave Hairspray) regarding labeling, safety, and intended use.
- Technological Characteristics: Both the proposed device and the predicate device are portable cryosurgical systems using a canister with cryogen and an applicator.
- Conclusion: The device is deemed safe, effective, and substantially equivalent to the predicate devices.
Therefore, I cannot provide a table of acceptance criteria or details of a study proving the device meets them from the given text.
To address the specific points of your request, based only on the provided text:
- A table of acceptance criteria and the reported device performance: Not available in the provided text. The document asserts substantial equivalence based on intended use, technological characteristics, and safety/labeling similarities rather than presenting a performance study with defined criteria.
- Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable. No test set or performance data is presented.
- 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. No test set or ground truth establishment process is described.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No test set or adjudication is mentioned.
- 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 physical cryosurgical system, not an AI-assisted diagnostic tool.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This refers to a physical device, not an algorithm.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. No ground truth is described for a performance study.
- The sample size for the training set: Not applicable. No training set is mentioned as this is not an AI/algorithm-based device.
- How the ground truth for the training set was established: Not applicable. No training set or ground truth for it is described.
§ 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.