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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

Device Description

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.

AI/ML Overview

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.

Characteristic / "Acceptance Criteria"	Predicate Device (Cryoprobe-C K024009)	CryOmega (Reported Device Performance)
Intended Use	To destroy tissue during surgical procedures by applying extreme cold.	Disposable device intended for surgical destruction of target tissue by applying cryogenic gases at extreme low temperatures. Examples of treatable lesions listed: Genital Lesions, Molluscum Contagiosum, Seborrheic Keratoses, Skin Tags, Verruca Plantaris, Verruca Vulgaris, Verruca Plana, Actinic Keratosis, Lentigo.
Cryogen Characteristics	Nitrous Oxide, N2O at 50 bar pressure. 8g or 16g cartridges.	Nitrous Oxide, N2O at 50 bar pressure. 16g cartridge.
Materials	Housing: Aluminum; Micro-Applicator: unknown; Lock Cap: Plastic; Filter: Unknown; O-rings: Unknown; Cartridge: Metal.	Housing: Plastic; Filter: Plastic; O-rings: Butadiene-rubber; Cartridge: Metal.
Mode of Use	Apply Spray Topically.	Apply Spray Topically.
Mechanism of action	N2O gas is delivered to the treatment site at -89°C to effect cellular destruction.	N2O gas is delivered to the treatment site at -89°C to effect cellular destruction.
Storage Conditions	<50°C	<50°C
Safety (ASTM Standard)	Complies with ASTM: F882-84 (96) for Cryosurgical Medical Instruments.	Complies with ASTM: F882-84 (96) for Cryosurgical Medical Instruments.
Gas Cartridge Safety	Cartridge can expel unused gas under pressure during cartridge replacement.	Unit is discarded after liquefied gas is emptied (implying increased safety due to inaccessibility of high-pressure cartridge).
Treatment Procedure	Suggests Freezing of target tissue by spray.	Same.
Operation	Spray begins when gas cartridge is engaged. Continuous spray unless capped.	Gas dispensed using actuator lever. Spray controlled by on/off actuator.
Disposal	Main Unit is reusable with replaceable gas cartridges.	Whole Unit is disposable after liquefied gas is emptied from the cartridge.
Defined Operators	Physician or Licensed Practitioner.	Same.
Service/Repair	Return to Manufacturer.	Disposable once liquefied gas is emptied. No Servicing.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable as the document describes a physical medical device (cryosurgical unit), not a software or AI device requiring a test set of data. The "testing" mentioned refers to engineering and safety verifications, not clinical performance studies with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable. Ground truth for image interpretation or diagnosis is not relevant for this type of device submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable.

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 information is not applicable. This is not an AI-assisted device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not applicable. The "ground truth" relevant to this submission is the established performance and characteristics of the legally marketed predicate device (Cryoprobe-C) to which the CryOmega is being compared for substantial equivalence.

8. The sample size for the training set

This information is not applicable.

9. How the ground truth for the training set was established

This information is not applicable.

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