FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

Canister filled with a liquid mixture of the compressed gases dimethyl ether, propane, and isobutane
. Polyurethane foam swabs
. Detailed instructions including illustrated descriptions
The main component of the device is the pressurized aerosol canister containing cryogen spray. The canister is used with foam swabs, which are non-sterile, single-use applicators that are disposed after each use. The foam swabs allow the cryogen to be localized to a target lesion.
The one- to two-minute procedure begins by spraying cryogen onto a foam swab, which is then placed directly onto the lesion and held for 15-40 seconds. Upon removal of the swab from the skin, the frozen tissue appears white and begins thawing. The typical thaw time is 20-40 seconds.
This treatment methodology is simple and has been an accepted practice used by physicians for decades. It utilizes a standard cryogen composition profile to freeze lesions and destroy the underlying tissue through evaporative cooling. On the cellular level, both extracellular and intracellular ice formation are occurring.

AI/ML Overview

The provided document is a 510(k) summary for the Verruca-Freeze® H cryosurgical system. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving that the device meets specific acceptance criteria through a machine learning or AI algorithm's performance.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving a device meets these criteria in the context of an AI/ML powered device. The "performance data" mentioned refers to non-clinical tests of the cryosurgical process itself, not an algorithm's performance.

Here's why the document cannot answer the prompt's specific questions about AI/ML device performance:

Device Type: The Verruca-Freeze® H is a cryosurgical system, a physical medical device that applies cold to treat skin lesions. It is not an AI-powered or software-based medical device.
"Study" Context: The "performance testing" described in Section 6.2 ("Non-Clinical Performance Data") is about measuring the output temperature and effectiveness of the cryogen and applicators, and visually confirming ice ball formation. This is physical hardware performance testing, not an algorithmic study.
Absence of AI/ML Specifics: There is no mention of algorithms, training sets, test sets, ground truth establishment by experts, adjudication methods, or MRMC studies, all of which are relevant to evaluating AI/ML-based medical devices.
"Clinical Performance Data": Section 6.3 explicitly states, "There was no clinical testing required to support the medical device as the indications for use are equivalent to those of the predicate device. These types of devices have been on the market for decades and their clinical safety and efficacy has been established." This further confirms that no new clinical study was conducted for this submission, let alone one focused on AI/ML performance.

In summary, the provided document is a regulatory submission for a traditional medical device demonstrating substantial equivalence, not an AI/ML device showing performance against specific acceptance criteria.

Therefore, I cannot populate the requested table or answer the specific questions about the study design (sample sizes, expert qualifications, adjudication, MRMC, standalone performance, ground truth types, training set details) because this information is not present in the provided text.

Summary

Regulation Number and Section

§ 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.