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The ICEfy™ 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 destroy tissue (including prostate and kidney tissue, liver metastases, tumors, and skin lesions) by the application of extremely cold temperatures.

The ICEfx 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. Palliation of pain associated with metastatic lesions involving bone in patients who have failed or are not candidates for standard radiation therapy.

· 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, dermatoffbromas, small hemangiomas, multiple warts, plantar warts, actinic and sebortheic 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 ICEfx Cryoablation System is a mobile 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 ICEfx System uses high-pressure argon gas that circulates through closed-tip cryoablation needles to induce tissue freezing. Active tissue thawing is achieved by the use of CX technology in which a heating element inside the cryoablation needle can be energized to cause thawing.

The provided text is a 510(k) FDA clearance letter and summary for a medical device (ICEfx™ Cryoablation System). It describes the device, its intended use, and how it compares to a predicate device. However, it does not contain the information requested regarding acceptance criteria, sample sizes for testing, expert involvement, or any data from a multi-reader multi-case (MRMC) study or standalone AI performance.

The document states that "A full battery of verification and validation testing was conducted on the ICEfx Cryoablation System to ensure that the design, functionality, and performance met the specified requirements." It lists types of testing like system testing, electrical testing, mechanical testing, software testing, and usability testing, and concludes that "Test results demonstrated that the ICEfx Cryoablation System meets defined specifications..."

However, it does not provide the specific acceptance criteria, nor the quantitative results of these tests. The document emphasizes that the device is "substantially equivalent" to a predicate device by having the "same technology and principle of operation." This suggests that the "tests" were primarily to demonstrate conformity to existing standards and to ensure the new device performed equivalently to the predicate, rather than to establish novel performance metrics or to evaluate against new clinical endpoints in the way an AI/ML device might be assessed with a detailed performance study.

**Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for the test set or data provenance.
3. Number and qualifications of experts for ground truth.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study results or effect size.
6. Standalone performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.**

The document is a regulatory approval, not a detailed scientific study report that would contain such experimental data. The focus is on demonstrating substantial equivalence to a previously cleared device.

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