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The Histofreezer V indications for use as follows: l, 1,1,2-tetrafluoroethane, pentafluoroethane, and l, 1,1-tri fluoroethane is to be used for the treatment of verruca (warts) including plantar warts, seborrheic keratoses, actinic keratosis, achrochorodon, molluscum contagiosum, age spots, dermatofibroma, small keltoids, granuloma annulare, Porokeratosis Plantaris, Angiomas, Keratoacanthoma, chrondrodermatitis, epithelial nevus, Leukoplakia, granuloma pyogenicum, and pyogenic granuloma.

The Histofreezer V device utilizes extreme cold to facilitate the removal of benign topical lesions. The device utilizes a combination of 1.1.1.2-Tetrafluoroethane. Pentafluoroethane, and 1,1,1-Trifluoroethane delivered from the cannister of gas into a foam bud or cone which acts as a reservoir for the cryogen gas. To perform the treatment the bud or cone facilitates freezing the targeted lesion for up to 40 seconds .. The frozen lesion falls away over time and new epidermis grows in its place. One to four treatments with intervals of two weeks may be required.

The provided text is a 510(k) Premarket Notification from the U.S. FDA for the Histofreezer V device. This document does not describe acceptance criteria for an AI/ML powered medical device, nor does it detail a study that proves a device meets such criteria. Instead, it focuses on demonstrating substantial equivalence of the Histofreezer V, a cryosurgical unit, to a predicate device (CryoDose/McKesson) based on its technological characteristics and performance (specifically temperature attainment).

Therefore, I cannot provide the requested information regarding acceptance criteria, reported device performance, sample sizes, data provenance, expert qualifications, ground truth, MRMC studies, or standalone performance for an AI/ML device, as this information is not present in the provided text.

The text does include:

• A comparison of the Histofreezer V with its predicate device, CryoDose/McKesson (K130995), highlighting similarities in intended use, cryogen, cryogen gas boiling point, cone materials, mode of use, mechanism of action, safety, operation, and defined operators.
• A brief mention of "bench testing" that focused on "demonstrating the equivalency of temperatures over their treatment times while using cone or applicators from the CryoDose/McKesson device and Histofreezer V."
• A statement that the product was tested for biocompatibility according to FDA's guidance and ISO 10993 requirements.

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

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This document is an FDA 510(k) clearance letter for the Histofreezer® Verruca Plana, a cryosurgical device. As such, it does not contain the detailed information about acceptance criteria, study design, and performance metrics typically found in a clinical study report or a premarket approval (PMA) application.

The letter confirms that the device is "substantially equivalent" to legally marketed predicate devices. This substantial equivalence determination means that the FDA has agreed, based on the sponsor's submission (which would have included comparative performance data), that the new device is as safe and effective as a device already on the market. However, the letter itself does not provide the specifics of those studies.

Therefore, I cannot provide the requested information from the given text. The document is a regulatory approval, not a scientific study report.

To answer your request, if this were a hypothetical scenario where this document provided performance data relevant to AI/ML device approval, here's how I would approach it, highlighting why the current document is insufficient:

Based on the provided text, I cannot extract the specific acceptance criteria, study design, or performance metrics in the format requested. The document is a 510(k) clearance letter, which states that the device, Histofreezer® Verruca Plana, has been found "substantially equivalent" to a predicate device. It does not contain the detailed study results, acceptance criteria, or experimental setup typically required to answer the questions about device performance and validation.

Here's a breakdown of why each point cannot be addressed from the given text:

1. A table of acceptance criteria and the reported device performance: This information is not present. A 510(k) submission would include performance data demonstrating equivalence to a predicate, but the clearance letter itself doesn't report these details.
2. Sample size used for the test set and the data provenance: Not mentioned in the clearance letter.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not mentioned.
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: This device (Histofreezer) is a cryosurgical tool, not an AI/ML diagnostic or assistive device for human readers. Therefore, an MRMC study for AI assistance is not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned.
8. The sample size for the training set: Not applicable, as this is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable, as this is not an AI/ML device.

In summary, the provided FDA 510(k) clearance letter serves as a regulatory approval document and does not contain the detailed technical and clinical study information required to answer your specific questions regarding acceptance criteria and performance data. Such information would typically be found in the 510(k) submission itself, which is not provided here.

Ask a specific question about this device