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The Cryocare CS Surgical System is intended for use in open, minimally invasive or endoscopic surgical procedures in the areas in general surgery, urology, oncology, neurology, dermatology, ENT, proctology, pulmonary surgery and thoracic surgery. The system is designed to freeze/ablate tissue by the application of extreme cold temperatures including prostate and kidney tissue. liver metastases, tumors, skin lesions, and warts.

In addition, the system is intended for use in the following indications:

General Surgery

• · Destruction of warts or lesions
• · Palliation of tumors of the oral cavity, rectum and skin
  • Ablation of leukoplakia of the mouth, angiomas, sebaceous hyperplasia, basal cell tumors of the eyelid or canthus area, ulcerated basal cell tumors, dermatofibromas, small hemangiomas, mucocele cysts, multiple warts, hemorrhoids, anal fissures, perianal condylomata, pilonidal cysts, actinic and seborrheic keratoses, cavernous hemangiomas, recurrent cancerous lesions

Urology

• · Ablation of prostate tissue in cases of prostate cancer and benign prostatic hyperplasia
• · Gynecology
• · Ablation of malignant neoplasia or benign dysplasia of the female genitalia Oncology
• · Ablation of cancerous or malignant tissue
• · Ablation of benign tumors
• · Palliative intervention

Neurology

• · Freezing of nerve tissue in pain management/cryoanalgesia
  Dermatology
• · Ablation or freezing of skin cancers and other cutaneous disorders Proctology
• • Ablation of benign or malignant growths of the anus or rectum
• · Ablation of hemorrhoids

Thoracic Surgery

• · Ablation of arrhythmic cardiac tissue
• · Ablation of cancerous lesions

The Endocare Cryocare CS Surgical System is a mobile console system intended for cryoablative tissue destruction. The system consists of a compact, easy to operate console and associated accessories that include cryoprobes to deliver cold temperatures to the targeted tissue, and TempProbe devices to monitor temperatures in the surrounding tissue.

I am sorry, but the provided text does not contain the detailed information necessary to fully answer your request. The document is an FDA 510(k) clearance letter and its associated summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with acceptance criteria and performance metrics for a novel AI device.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance: While it mentions "bench performance," "software validation," "electrical safety," and "electromagnetic compatibility testing," it does not specify any quantitative acceptance criteria or the actual performance values achieved for the Cryocare CS Surgical System.
• Sample sized used for the test set and the data provenance: There is no mention of a test set, sample sizes, or data provenance.
• Number of experts used to establish the ground truth for the test set and their qualifications: No information about ground truth experts is provided.
• Adjudication method for the test set: No adjudication method is described.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done: The document does not describe such a study.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device described is a surgical system, not an AI algorithm, so this type of study is not applicable in this context.
• The type of ground truth used: Not applicable as there is no mention of a ground truth for performance evaluation in the context of an AI device.
• The sample size for the training set: Not applicable as this is not an AI device being trained.
• How the ground truth for the training set was established: Not applicable.

The document states: "Appropriate verification and validation activities were performed on the subject device to evaluate conformance to product specifications and equivalence to the predicate design. Testing included bench performance, software validation, electrical safety and electromagnetic compatibility testing. The results of all studies confirmed equivalency between the subject and predicate device, and that no new issues of safety or efficacy were raised." This generic statement confirms general testing was done for regulatory purposes, but provides no specifics about the criteria or results.

Therefore, I cannot extract the requested information from the provided text.

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