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The Visual-ICE MRI Cryoablation System is indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurology (including cryoanalgesia), thoracic surgery (with the exception of cardiac tissue), ENT, gynecology, proctology, and urology. This system is designed to destroy tissue (including prostate and kidney tissue, liver metastases, tumors, and skin lesions) by the application of extremely cold temperatures.

The Visual-ICE MRI 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 hemangiomas, mucocele cysts, multiple warts, plantar warts, actinic and seborrheic keratosis, cavernous hemangiomas, peri-anal condylomata, and palliation of tumors of the skin
• Gynecology Ablation of malignant neoplasia or benign dysplasia of the female genitalia
• . General surgery Palliation of tumors of the rectum, anal fissures, pilonidal cysts, and recurrent cancerous lesions, ablation of breast fibroadenomas
• ENT Palliation of tumors of the oral cavity and ablation of leukoplakia of the mouth
• Thoracic surgery (with the exception of cardiac tissue) •
• Proctology Ablation of benign or malignant growths of the anus or rectum

The Visual-ICE™ MRI Cryoablation System is a mobile system intended for cryoablative tissue destruction using a minimally invasive procedure. The Visual-ICE MRI Cryoablation System has been designed to permit the delivery of cryoablation treatments under visual guidance in an MR environment. The Visual-ICE MRI System is comprised of a Console, Mobile Connection Panel (MCP) and a Junction Box Assembly. The system is computercontrolled with a touch screen user interface that allows the user to control and monitor the procedure. The console is located in the control room, while the Mobile Connection Panel is located in the magnet room. Junction boxes mounted in the two rooms, and connection of the gas and signal lines between the junction boxes occurs via a penetration panel. The Mobile Connection Panel is constructed of non-ferromagnetic materials to allow for placement within the magnet room close to the scanner. The Visual-ICE MRI Cryoablation System was designed for compatibility with Galil Medical's previously cleared IceRod MRI and IceSeed MRI cryoablation needles (K051052).

The provided text describes the Visual-ICE MRI Cryoablation System, which is a cryosurgical tool. However, the document is a 510(k) summary for a premarket notification to the FDA, focused on establishing substantial equivalence to predicate devices, not a study proving the device meets specific acceptance criteria in the context of an AI/ML device.

Therefore, the information required to populate the fields regarding acceptance criteria, study details, ground truth, and sample sizes for an AI/ML device is not present in the provided document. The document describes a medical device, which is an MRI Cryoablation System, and its purpose is to demonstrate its equivalence to previously cleared devices, not to present a performance study against specific acceptance criteria for an AI/ML component.

The document discusses Verification and Validation testing, including system, electrical, mechanical, packaging, labeling, and software testing, as well as design, usability, and animal testing. These are general engineering and medical device validation steps, not specific metrics for evaluating an AI/ML algorithm's performance.

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