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The CryoThin™ Surgical System is intended for cryosurgery in the fields of general surgery, urology, oncology, neurology, dermatology, ENT, proctology, pulmonary surgery. The system is designed to freeze/ablate tissue by the application of extreme cold temperatures including prostate and kidney tissue, liver metastase, tumors, skin lesions, and warts. The system has the following specific indications:

General Surgery

• · Destruction of warts or lesions
• · Palliation of tumors of the oral cavity, rectum and skin
• · Ablation of breast fibroadenomas
  · 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, multiple warts, plantar 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 cancerous lesions

Cryosurgery is the use of ultra-low temperatures for selectively freezing and destroying diseased tissues in situ. The CryoThin™ Surgical System is designed to ablate benign and malignant tissues using cryosurgery.

The system utilizes the Joule-Thomson effect for freezing. It uses high-pressure argon gas that undergoes throttling expansion to induce freezing inside the closed tip of the Cryo probe to freeze the target tissue around the probe tip. Low-pressure argon is electrically heated and blown into the probe tip to thaw the tissue around it.

The CryoThin Surgical System consists of a console, a cart, and accessories. The system must be used in conjunction with the Cryo probes for freeze and thaw functions, and the Temp probes for monitoring the temperature in target or adjacent tissues.

The provided FDA 510(k) summary for the CryoThin™ Surgical System and Accessories primarily focuses on demonstrating substantial equivalence to predicate devices through technical comparisons and non-clinical performance testing. It does not include an acceptance criteria table with reported device performance for clinical endpoints, nor does it detail a clinical study with human patients, statistical metrics like sensitivity/specificity, or expert adjudication for ground truth.

Here's an analysis based on the information provided, highlighting what is present and what is notably absent:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not contain a table of acceptance criteria with reported device performance for clinical outcomes. Instead, it lists comprehensive non-clinical tests that the device passed to demonstrate safety and performance.

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided in the document. The testing described is non-clinical and lab-based (e.g., electrical safety, biocompatibility, sterilization validation, iceball formation). There is no mention of a human patient test set.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This information is not applicable as no human-in-the-loop clinical test set or ground truth established by experts is described in this 510(k) summary. The "ground truth" for non-clinical tests would be defined by the technical standards themselves (e.g., a device either meets the specified resistance or it doesn't).

4. Adjudication Method for the Test Set

This information is not applicable as no human-in-the-loop clinical test set requiring adjudication is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The document explicitly states: "The information and data provided in this Traditional 510(k) application demonstrated that the subject device met the safety and performance specifications and did not raise any new safety or effectiveness issues. Thus, the subject device is considered to be substantially equivalent to the legally marketed predicate devices." This indicates a substantial equivalence pathway, which typically relies on demonstrating similar technological characteristics and performance to already cleared devices, rather than conducting new clinical effectiveness studies, especially MRMC studies comparing human readers with and without AI assistance. This device is a surgical system, not an AI diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No. This device is a cryosurgical system, a physical medical device, not an algorithm or AI product requiring standalone performance evaluation in the context of diagnostic accuracy. The "standalone" performance here refers to the device's ability to perform its intended function (e.g., forming an iceball of a certain size and temperature), which is covered by the "Iceball and isotherm testing." The summary states it demonstrated the ability to cool target tissue to desirable therapeutic temperature, implying successful standalone function for its primary mechanism.

7. The Type of Ground Truth Used

For the non-clinical tests, the "ground truth" is established by the technical specifications and standards (e.g., IEC, ISO, ASTM standards) against which the device performance is measured. For the iceball and isotherm testing, the ground truth would be the measured temperature and iceball size achieved compared to predefined therapeutic targets/specifications.

8. The Sample Size for the Training Set

This information is not applicable. This is a physical cryosurgical device, not a machine learning or AI model that requires a training set of data.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as there is no training set for an AI model.

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