(90 days)
The Histofreezer® device is indicated for use in the treatment of the following: Actinic Keratosis Genital Warts Lentigo Molluscum Contagiosum -Seborrhoeic Keratosis_ Skin Tags Verruca Plantaris -Verruca Vulgaris
Not Found
The provided text does not contain information about the acceptance criteria or a study proving device performance in the context of AI/ML or comparative effectiveness. The document is an FDA 510(k) clearance letter for a medical device called Histofreezer®, indicating its substantial equivalence to pre-amendment devices and listing its intended uses.
Therefore, I cannot provide the requested table or answer the specific questions about acceptance criteria, study details, sample sizes, ground truth establishment, or human-in-the-loop performance related to AI/ML.
The clearance letter focuses on regulatory approval based on substantial equivalence, not on a detailed performance study with quantifiable metrics as would be expected for AI/ML device evaluations.
§ 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.