Search Results

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.

Ask a specific question about this device

The Histofreezer® device is indicated for use in the treatment of the following: Genital Warts Molluscum Contagiosum Seborrhoeic Keratosis Skin Tags Verruca Plantaris Verruca Vulgaris Verruca Plana

Not Found

The provided document is a 510(k) premarket notification letter from the FDA for a device called "Histofreezer Device." It primarily discusses the substantial equivalence of this device to a legally marketed predicate device and grants permission to market it.

Crucially, the document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, or specific study results (like MRMC or standalone performance). It lists the "Indications For Use" for the device, but this is not equivalent to performance data or acceptance criteria.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, nor can I provide details about the study that proves the device meets those criteria, as this information is not present in the provided text.

Ask a specific question about this device