Search Results

The CryOmega Flexx is intended for the surgical destruction of tissue by applying cryogenic gases at extreme low temperatures.

The List below shows examples of the types of lesions that may be treated:

• Molluscum Contagiosum
• · Skin Tags
• · Actinic Keratosis
• Lentigo
• · Verruca Plana
• · Verruca Vulgaris
• Verruca Plantaris
• · Genital Lesions
• · Seborrheic Keratosis

The CryOmega Flexx device is designed to dispense a continuous stream of liquid nitrous oxide when actuated. The device uses a 16g or 25g cartridge of nitrous oxide that is sprayed once the gas cartridge has been screwed onto the applicator. Licensed Practitioners can then dispense the gas for use in procedures requiring the destruction of tissue using the extreme cold of nitrous oxide, N2O (-89ºC).

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the CryOmega Flexx device:

The document is a 510(k) premarket notification summary for the CryOmega Flexx, a cryosurgical unit. It focuses on demonstrating substantial equivalence to a predicate device (CryOmega-K102006) rather than defining and proving new acceptance criteria for novel performance claims. Therefore, the "acceptance criteria" here are essentially the performance characteristics of the predicate device, which the new device must meet or be substantially equivalent to.

1. Table of Acceptance Criteria and Reported Device Performance

Ask a specific question about this device

The CryOmega is a disposable device intended for the surgical destruction of target tissue by applying cryogenic gases at extreme low temperatures. The list below shows examples of the type of lesions that can be treated.

-Genital Lesions -Molluscum Contagiosum -Seborrheic Keratoses -Skin Tags -Verruca Plantaris -Verruca Vulgaris -Verruca Plana -Actinic Keratosis -Lentigo

The CryOmega device is designed to dispense a continuous stream of liquid nitrous oxide when actuated. The device contains a 16g cartridge of nitrous oxide that is dispensed once the device is activated. Physicians or medical professionals can then dispense the gas for use in procedures requiring the destruction of tissue using the extreme cold of nitrous oxide (-89°C). Unlike the predicate device, the CryOmega is designed to be self contained and disposable after all of the liquefied gas has been dispensed.

The provided text is a 510(k) Premarket Notification Summary for the CryOmega device. It focuses on demonstrating substantial equivalence to a predicate device (Cryoprobe-C) rather than presenting a standalone study with detailed acceptance criteria and performance metrics typically found for AI/software-as-a-medical-device (SaMD) clearances.

Therefore, much of the requested information regarding AI device testing (such as sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, or standalone performance for an algorithm) is not applicable to this document. The CryOmega is a physical cryosurgical unit, not an AI/software device.

However, I can extract information related to the device's characteristics and the basis for its substantial equivalence.

Here's a breakdown of the requested information based only on the provided text:

1. A table of acceptance criteria and the reported device performance

Since this is a 510(k) for a physical device, the "acceptance criteria" are not framed as statistical performance metrics for an algorithm but rather as characteristics demonstrating substantial equivalence to a predicate device. The "reported device performance" is essentially a comparison of its characteristics to the predicate.

Ask a specific question about this device