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The ISOLIS cryoprobes, used with the Cryocare Systems, are intended for use in open, minimally invasive or endoscopic surgical procedures in the areas in general surgery, urology, gynecology, neurology, dermatology, ENT, proctology, pulmonary surgery and thoracic surgery. The systems are designed to freeze/ablate tissue by the application of extreme cold temperatures including prostate and kidney tissue, tumors, skin lesions, and warts.

In addition, the systems are 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 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, 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 cancerous lesions

The ISOLIS cryoprobe is a single use, disposable device designed for use with CryoCare® Systems. ISOLIS cryoprobes are designed to deliver cold temperatures for cryoablation using high-pressure argon gas circulated through the cryoprobe, followed by active thawing using helium gas. The refrigerative and warming capability is limited to the distal end of the probe shaft that is comprised of stainless steel and is designed with a pointed tip to facilitate cryoprobe insertion and placement.

This document is a 510(k) Premarket Notification for the ISOLIS Cryoprobe, which aims to demonstrate substantial equivalence to a predicate device (CRYOCARE TOUCH™ System and Accessories, K201588). The document primarily focuses on explaining the device, its intended use, and comparing its technical characteristics to the predicate. It does not contain a study designed to prove the device meets specific acceptance criteria in the way one might expect for an AI/ML-driven device or a device requiring clinical performance validation against metrics like sensitivity/specificity.

The information provided describes a design and performance validation process rather than a clinical study with human subjects, ground truth adjudication, or statistical metrics like AUC, sensitivity, or specificity commonly associated with AI/ML device performance. The "acceptance criteria" here are implicitly related to the device's functional and performance characteristics mirroring or improving upon the predicate device within established safety and effectiveness parameters.

Here's an attempt to structure the available information relevant to your request, with significant caveats that much of the information you've asked for (e.g., sample size for AI, number of experts for ground truth, MRMC study, effects of AI assistance) is not applicable or not present in this type of premarket notification for a physical medical device like a cryoprobe.

Device: ISOLIS Cryoprobe (K230271)

Type of Device: Cryosurgical Unit And Accessories (Product Code: GEH)

Summary of Acceptance Criteria and Device Performance (Based on Bench Testing and Comparison to Predicate):

• Handle Construction & Materials: Heat shrink (polyolefin or PVDF) covering a stainless-steel vacuum handle (Predicate: Plastic ABS injection molded handle). Rationale: Smaller, slimmer handle and provides better improved insulation.
• Heat Exchanger: Copper-nickel alloy finned tubing coiled around a stainless-steel mandrel (Predicate: Copper screw-type cryostat). Rationale: Increases surface area for thermal exchange, maximizing freeze performance.
• Accessories: Two Return Hose Clips added to the Return Hose. Rationale: Added as an optional feature to aid in stability of the Return Hose and probe, especially during CT imaging. |
  | Usability | Successfully passed usability evaluations. |
  | Packaging & Sterilization| Successfully passed packaging tests. Sterilization method (Gamma Irradiation) and Single-Use, Sterile, Disposable status are the same as the predicate. |
  | Biocompatibility | Successfully passed biocompatibility evaluations (10993-1, Externally communicating medical device with tissue/bone/dentin contact with limited duration (≤24 hours)). Same as predicate. |
  | Risk Profile | Verified that the differences between the subject and predicate devices did not alter the overall risk profile. |

Study Details (Relevant to a physical device without AI/ML component):

1. Sample Size Used for the Test Set and Data Provenance:

   • Sample Size: Not explicitly stated as a "sample size" in the context of patient data or clinical images. The testing described is bench testing of the physical device variants. The document lists 4 variants of the ISOLIS Cryoprobe (PC-2.1E, PC-2.1S, PC-2.1EL, PC-2.1SL). It is implied that these variants, or representative samples thereof, were subjected to the described bench tests.
   • Data Provenance: Not applicable in the context of clinical data. The "data" comes from engineering bench tests conducted by Varian Medical Systems, Inc. (located in Austin, TX, USA). The testing is non-clinical.

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

   • Not applicable. "Ground truth" in the context of this device's performance refers to the objective physical measurements obtained during bench testing (e.g., isotherm size, temperature profiles) and engineering design specifications. These are established through validated measurement methods and engineering principles, not expert consensus on medical images or clinical outcomes.

3. Adjudication Method for the Test Set:

   • Not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements in expert labeling of data, typically in AI/ML performance studies or clinical trials involving subjective assessments. This document describes objective bench testing.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

   • No. This device is a physical cryoprobe, not an AI/ML-driven diagnostic tool. MRMC studies are used to evaluate human reader performance, often with and without AI assistance. This type of study is not relevant for this device.
   • Effect size of how much human readers improve with AI vs without AI assistance: Not applicable.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

   • No. This device does not contain an "algorithm" in the sense of AI/ML. Its function is based on physical principles (Joule-Thomson Effect). The performance evaluation is based on the physical properties and functional output of the probe itself.

6. The type of ground truth used:

   • The "ground truth" for this device's performance testing is based on objective physical measurements and engineering specifications. For example, the "size of isotherm" is a measurable physical property of the cryoprobe's freezing capability, measured directly during bench testing under controlled conditions. "Temperature-time history" is also a direct physical measurement.

7. The sample size for the training set:

   • Not applicable. This document describes a physical medical device, not an AI/ML model for which a "training set" would be relevant.

8. How the ground truth for the training set was established:

   • Not applicable. As there is no AI/ML model or training set, this question is not relevant.

Conclusion from the Document:

The manufacturer concluded that the ISOLIS Cryoprobe is substantially equivalent to the predicate device (Slimline probes) based on:

• Successful completion of comprehensive bench testing (functional, electrical safety, performance, physical, usability, packaging, bioburden, gamma sterilization adoption, and biocompatibility).
• Demonstration that the device meets established design criteria.
• Confirmation that the differences in design and performance (e.g., improved isotherm size, sharper tip, better handle insulation) do not alter the overall risk profile.
• The fact that the indications for use and principle of operation are identical to the predicate device.
• The isotherm and temperature-time history data are similar to (or improved upon) the predicate device.

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