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The Visual-ICE™ Cryoablation System is intended for cryoablative destruction of tissue during surgical procedures. The Visual-ICE System is indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurology (including cryoanalgesia), thoracic surgery, ENT, gynecology, oncology, proctology, and urology. The system is designed to destroy tissue by the application of extreme cold temperatures including prostate and kidney tissue, liver metastases, tumors, skin lesions, and warts.

The Visual-ICE Cryoablation System has the following specific indications:

• Urology (ablation of prostate tissue in cases of prostate cancer and Benign Prostate Hyperplasia "BPH")
• . Oncology (ablation of cancerous or malignant tissue and benign tumors, and palliative intervention)
• . Dermatology (ablation or freezing of skin cancers and other cutaneous disorders. Destruction of warts or lesions, angiomas, sebaceous hyperplasia, basal cell tumors of the eyelid or canthus area, ulcerated basal cell tumors, dermatofibromas small hemanglomas, mucocele cysts, multiple warts, plantar warts, actinic and seborrheic keratoses, cavernous hemanglomas, perianal condylomata, and palliation of tumors of the skin.)
• . Gynecology (ablation of malignant neoplasia or benign dysplasia of the female genitalia)
• . General surgery (palliation of the rectum, hemorrhoids, anal fissures, pilonidal cysts, and recurrent cancerous lesions, ablation of breast fibroadenoma)
• . ENT (Palliation of tumors of the oral cavity and ablation of leukoplakia of the mouth)
• Thoracic surgery (ablation of arrhythmic cardiac tissue cancerous lesions) .
• . Proctology (ablation of benign or malignant growths of the anus or rectum, and hemomhoids)

The Visual-ICE Cryoablation System is a mobile console system intended for cryoablative tissue destruction using a minimally invasive procedure. The system is computer-controlled with a touch screen user interface that allows the user to control and monitor the procedure. The therapy delivered by the system is based on the Joule-Thomson effect displayed by compressed gases. The Visual-ICE System uses high-pressure argon gas that circulates through closed-tip cryoablation needles to induce tissue freezing. Active tissue thawing is achieved by circulating. helium gas through the needles or, alternatively, by the use of Galil Medical i-Thaw technology in which a heating element inside the cryoablation needle can be energized to cause thawing.

This Special 510(k) is being submitted to modify the software with a variety of changes to enhance usability of the system. These changes are primary being made to the user interface and the service and maintenance screens. Basic functionality of the system remains unchanged, however, the following functional modifications have been made:

• . Organ map display has been modified to allow users to place MTS needles on the Organ Мар,
• When all channels are locked and linked together the Test All button icon state identifies the . state for all channels.
• The software defaults all needles to the first 1-wire needle that was attached. .
• User interface can display up to three large timers instead of two. .
• Freeze-thaw cycles can now be programmed for all channels using the All button, .
• The software wams the user of low gas when the remaining gas time reaches 10 minutes . instead of 5 minutes,
• "Stick" intensity has been changed from 20% to 5%, .
• Helium low-pressure warning was reduced to 1800 PSI from 2100 PSI. .

Here's an analysis of the provided text regarding the acceptance criteria and study for the Visual-ICE® Cryoablation System, Software Revision 1.2.2:

This submission is a Special 510(k) for software modifications to an existing device (Visual-ICE® Cryoablation System, K113860). Special 510(k)s are for well-established devices where changes do not alter the fundamental scientific technology or intended use, and where performance can be verified through existing test methods. This typically means a full clinical study with acceptance criteria for the device's diagnostic performance (e.g., sensitivity, specificity) against a ground truth would not be required or presented in this type of submission. Instead, the focus is on verification and validation of the software changes to ensure they did not introduce new risks or negatively impact existing functionality.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size: Not applicable in the context of a diagnostic performance study, as this is a software update for a cryoablation system, not a diagnostic device. The "test set" here refers to the software verification and validation tests. The document states a "complete software verification test was conducted" but does not specify the number of individual test cases or scenarios.
• Data Provenance: Not applicable for a software verification study. The tests would have been performed by the manufacturer (Galil Medical Inc.) in a testing environment.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Number of experts: Not applicable. The "ground truth" for a software verification study involves comparing the software's behavior against its functional specifications and requirements. This is typically established by software engineers and quality assurance personnel, not medical experts for a diagnostic assessment.

4. Adjudication method for the test set

• Adjudication method: Not applicable. Software verification involves testing against defined specifications. Test failures would be reported and addressed, but there isn't a "consensus" or "adjudication" process in the medical expert sense.

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

• MRMC Study: No. This is not a diagnostic device with an AI component that assists human readers.

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

• Standalone Performance: Not applicable. This is a cryoablation system where the software controls the hardware and user interface for a medical procedure performed by a clinician. It's not an algorithm that performs a task autonomously in a "standalone" fashion such as diagnosing an image.

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

• Type of Ground Truth: The "ground truth" for this software update is the software requirements specification and design documentation. The verification testing confirms that the software's behavior matches these predefined requirements.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This is not a machine learning or AI-driven system that requires a "training set."

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

• Ground Truth for Training Set: Not applicable, as there is no training set for this type of software update.

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