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The CRYO-HIT™ System for MRI is intended for cryogenic destruction of tissue during surgical procedures. It is indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurology, 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 CRYO-HIT™ System for MRI, like the already cleared CRYO-HIT™ 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 ablation of benign tumors, and palliative intervention)

Dermatology (ablation or freezing of skin cancers and other cutaneous disorders)

Gynecology (ablation of malignant neoplasia or benign dysplasia of the female genitalia)

General surgery (destruction of warts or lesions, palliation of tumors of the oral cavity, rectum and skin, and ablation of leukoplakia of the mouth, 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, hemorroids, anal fissures, perianal conylomata, pilonidal cysts, actinic and seborrheic keratoses, cavernous hemanglomas, and recurrent cancerous lesions)

Thoracic surgery (ablation of arrhythmic cardiac tissue, and ablation of cancerous lesions)

Proctology (ablation of benign or malignant growths of the anus or rectum, and ablation of hemorrhoids)

The CRYO-HIT™ System for MRI may be used with a magnetic resonance imaging (MRI) device or an ultrasound device to locate the target tissue, ensure correct placement of the probes and monitor the size of the iceball. The MRI or ultrasound device provides real-time visualization of the cryosurgical procedure.

The CRYO-HIT™ system for MRI is the exact same device as Galil Medical LTD's cleared System (K991517) except for the following technological modification: (1)- the additional MRI kit and (2) the availability of more probe types: 2 mm probe, surface probe, and disk shaped probe (The probes cleared for use with the modified CRYO-HIT™ System under K991272 include the same 2 mm probes, surface and disk shape probes, proposed for use with the CRYO-HIT™ for MRI).

The provided text describes the CRYO-HIT™ System for MRI and its indications for use, but it does not contain specific information about acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, or any comparative effectiveness studies.

The document is a 510(k) summary and a subsequent correction letter from the FDA, focusing on substantial equivalence to a predicate device (CRYO-HIT™ 200 System, K991517) based on similar intended use, principle of operation, and technological characteristics. It highlights the modifications (MRI kit and additional probe types) that distinguish the new device from the predicate.

Therefore, I cannot fulfill the request for information regarding acceptance criteria, study details, and sample sizes as this information is not present in the provided text.

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