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XSense Cryoablation System with CryoProbes is intended for cryogenic destruction of tissue during surgical procedures by the application of extreme cold temperatures.

XSense Cryoablation System with CryoProbes is indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurology (including cryoanalgesia), thoracic surgery, ENT, gynecology, oncology, proctology, and urology.

The system is designed to destroy tissue by the application of extreme cold temperatures including fibroadenomas, prostate and kidney tissue, liver metastases, tumors, skin lesions, and warts.

XSense Cryoablation System with CryoProbes may be used with an imaging device such as an ultrasound to provide realtime visualization of the cryosurgical procedure.

The system has the following specific indications:

• · Urology Ablate prostate tissue in cases of prostate cancer and benign prostatic hyperplasia (BPH).
• · Oncology - Ablation of cancerous or malignant tissue and benign tumors and palliative intervention.
• · Dermatology - Ablation or freezing of skin cancers and other cutaneous disorders. Palliation of the skin. Destruction of warts or lesions.
• · Gynecology - Ablation of malignant neoplasia or benign dysplasia of the female genitalia.
• · ENT (Ear, Nose, and Throat) - Palliation of tumors of the oral cavity and ablation of leukoplakia of the mouth.
• · General Surgery - Ablation of breast fibroadenomas, leukoplakia of mouth, angiomas, sebaceous hyperplasia, basal cell tumors of the eyelid or canthus area, ulcerated basal cell tumors, dermatofibromas, mucocele cysts, multiple warts, plantar warts, hemorrhoids, anal fissures, perianal condylomata, pilonidal cysts actinic and seborrheic keratoses, cavernous hemangiomas, recurrent cancerous lesions. Palliation of tumors of the rectum, hemorrhoids, anal fissures, pilonidal cysts, and recurrent cancerous lesions. Destruction of warts or lesions. Palliation of the oral cavity, rectum, and skin.
• · Thoracic Surgery - Ablation of arrhythmic cardiac tissue and cancerous lesions.
• · Proctology - Ablation of benign or malignant growths of the anus and rectum and hemorrhoids.

The XSense Cryoablation System with CryoProbes is operated in conjunction with an imaging system, such as ultrasound, to provide real-time visualization of the cryosurgical procedure, used in a professional healthcare environment for cryotherapy according to IceCure Medical's technology. The device technology is based on the delivery of the lowtemperature cryogen under pressure from the internal dewar to the CryoProbe's tip, enabling it to reach very low temperature, due to the thermal energy transfer principle that occurs as a result of phase transfer from liquid to gas of nitrogen at the tip of the CryoProbe, and thus freeze and destroy the treated tissue that the CryoProbe comes in contact with.

The XSense Cryoablation System with CryoProbes is the next generation of its predicatethe already cleared ProSense™ Cryoablation System (K183213) and is part of the IceCure family of cryoablation products. The XSense Cryoablation System with CryoProbes operates in the same manner as the previous design of the ProSense™ Cryoablation System. The XSense Cryoablation System will include the following additional accessories: (1) CryoProbes that are available in two configurations, (2) an external 25 liters dewar with a supporting cart, (3) an Introducer, and (4) a Holder.

The system is comprised of three main subsystems: XSense (console), CryoProbes, External dewar. Optional accessories: Introducer, Holder.

The provided text is a 510(k) Summary for the XSense Cryoablation System with CryoProbes. It compares the subject device to a predicate device (ProSense™ Cryoablation System) to demonstrate substantial equivalence, rather than providing a performance study of an AI/ML powered device.

Therefore, the document does not contain the information requested regarding acceptance criteria and performance studies for an AI/ML device. Specifically, it lacks:

• A table of acceptance criteria and reported device performance for an AI/ML model.
• Details on sample size, data provenance, expert adjudication, MRMC studies, or standalone algorithm performance.
• Information on ground truth establishment or training set details relevant to AI/ML.

The provided text focuses on the device's intended use, technological characteristics, and safety and effectiveness relative to a traditional medical device predicate, not an AI-powered one.

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The IceCure Family (IceSense™3, ProSense™, and MultiSense™) cryoablation system is intended for cryogenic destruction of tissue during surgical procedures by the application of extreme cold temperatures. It is indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurology (including cryoanalgesia), 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 system has the following specific indications: Urology (ablate prostate tissue in cases of prostate cancer and benign prostatic hyperplasia (BPH)). Oncology (ablation of cancerous or malignant tissue and benign tumors and palliative intervention). Dermatology (ablation or freezing of skin cancers and other cutaneous disorders. Palliation of tumors of the skin. Destruction of warts or lesions). Gynecology (ablation of malignant neoplasia or benign dysplasia of the female genitalia). ENT (Palliation of tumors of the oral cavity and ablation of leukoplakia of the mouth). General Surgery (ablation of leukoplakia of mouth, angiomas, sebaceous hyperplasia, basal cell tumors of the eyelid or canthus area, ulcerated basal cell tumors, dermatofibromas, mucocele cysts, multiple warts, plantar warts, hemorrhoids, anal fissures, perianal condylomata, pilonidal cysts actinic and sebortheic keratoses, cavernous hemangiomas, recurrent cancerous lesions. Palliation of the rectum, hemorrhoids, anal fissures, pilonidal cysts, and recurrent cancerous lesions. Destruction of warts or lesions. Palliation of the oral cavity, rectum, and skin. Ablation of breast fibroadenomas). Thoracic Surgery (ablation of arrhythmic cardiac tissue and cancerous lesions). Proctology (ablation of benign or malignant growths of the anus and rectum and hemorrhoids). The system may be used with imaging device like ultrasound to provide real-time visualization of the cryosurgical procedure. MultiSense™ System is indicated for three probe configuration only.

The IceCure Family of cryotherapy devices includes the IceSense™3 single-probe system (cleared under 510(k) #K102360 and rebranded as ProSense™), and MultiSense™ – a new system that accommodates up to three cryoprobes operating in parallel. The systems are used to destroy unwanted tissue by application of extreme cold to the selected sites. The devices deliver cold temperatures to targeted tissue by pressurized liquid nitrogen closed system and a disposable cryoprobe. Various cryoprobes are available. The devices consist of a main chassis for the cooling system, a controller, a touch screen, a foot pedal and a cryohandle that controls the system and holds the probe. Safety measures of the system include alarms, safety valve, emergency button and automatic abortion of the procedure in case of technical malfunction.

This document is a 510(k) premarket notification for the IceCure Family Cryoablation System, specifically K183213. It details the device's characteristics and compares it to predicate devices to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and study proving the device meets them, based on the provided text:

Important Note: This submission is for a medical device (cryoablation system) and not an AI/software device that would typically involve a multi-reader multi-case (MRMC) study or complex AI performance metrics like sensitivity, specificity, etc., established against expert ground truth for image interpretation. The "acceptance criteria" here relate to the engineering and performance specifications of the physical device and its cryoablation capabilities, compared to its predicates.

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device (cryoablation system), the acceptance criteria are based on functional performance, safety standards, and equivalence to predicate devices, rather than diagnostic accuracy metrics of an AI.

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

The document does not explicitly state a "sample size" in terms of number of cases or patients for a test set, as this was not a clinical performance study in the way an AI diagnostic device would require.

• Test Set: The "test set" here refers to the physical devices and their components undergoing bench testing, electrical safety, EMC, and sterilization validation. The number of units tested is not specified but would follow standard engineering and quality assurance protocols for device validation.
• Data Provenance: The data provenance is from bench testing and validation activities performed by the manufacturer (IceCure Medical LTD.), likely at their facility in Israel, in accordance with international and FDA standards. This is prospective testing as it's part of the device development and regulatory submission process. There is no mention of patient data (retrospective or prospective) for performance evaluation, as clinical testing was not deemed necessary for this 510(k) submission.

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

This information is not applicable in the context of this device and submission. "Ground truth" in this submission refers to:

• Established engineering specifications and performance targets (e.g., specific cryotemperature, iceball size, electrical safety limits).
• Compliance with recognized industry standards (e.g., ISO, IEC).
• Comparison to the performance of legally marketed predicate devices.

These are validated through engineering measurements, not via expert interpretation of data like in an image-based AI diagnostic study.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (e.g., 2+1, 3+1) are typically used for consensus reading in clinical studies, particularly for human ground truth establishment in diagnostic accuracy studies. For device performance testing, results are quantitative measurements against predefined specifications.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. A MRMC study was not conducted because:

• This is a physical cryoablation system, not an AI or diagnostic imaging device that assists human readers in interpretation.
• The FDA determined that "Clinical testing was not required to demonstrate the safety and effectiveness of the device."

Therefore, no effect size of human readers improving with AI assistance is applicable or reported.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)

Not applicable. This device is a cryoablation system, which is a surgical tool, not a diagnostic algorithm. Its performance is evaluated on its ability to generate an iceball, maintain temperatures, and conform to safety standards, not on an algorithm's diagnostic output.

7. Type of Ground Truth Used

The "ground truth" for this device's performance acceptance is based on:

• Engineering Specifications: Predefined quantitative targets for device function (e.g., iceball size, temperature ranges, operational parameters).
• Compliance with Recognized Standards: Meeting requirements of international standards for electrical safety (IEC 60601-1, IEC 60601-1-2), sterilization (ISO 11135), and biocompatibility (ISO 10993-1).
• Equivalence to Predicate Device Performance: Demonstrating that the performance characteristics (e.g., iceball formation, temperature control) are "similar" to or "as safe and effective as" those of the already cleared predicate devices.

8. Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable, as there is no training set for this type of device.

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The IceSense3 is intended for cryogenic destruction of tissue during surgical procedures. The IceSense3 is indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, thoracic surgery, gynecology, oncology, proctology, and urology. The IceSense3 may be used with an ultrasound device to provide real-time visualization of the cryosurgical procedure.

The IceSense3 device is used to destroy unwanted tissue by application of extreme cold to the selected sites. The device delivers cold temperatures to targeted tissue by pressurized liquid nitrogen closed system and a disposable cryoprobe. Various cryoprobes are available. The device consists of a main chassis for the cooling system, a controller, a touch screen, a foot pedal and a cryohandle that controls the system and holds the probe. Safety measures of the system include alarms, safety valve, emergency button and automatic abortion of the procedure in case of technical malfunction.

The device discussed is the IceCure Medical IceSense3.

Summary of Acceptance Criteria and Device Performance:

The provided text does not specify quantitative acceptance criteria in terms of clinical outcomes (e.g., specific percentages of lesion shrinkage, recurrence rates, etc.) for the IceSense3 device. Instead, the submission relies on demonstrating substantial equivalence to predicate devices. This means that its performance is considered acceptable if it is comparable to already cleared devices.

The primary performance metric explicitly stated for the IceSense3 is its ability to create an iceball of a certain size within a specific timeframe.

Study Details:

1. Sample size used for the test set and the data provenance:

   • The document does not specify a distinct "test set" in the context of a clinical study with a defined sample size of patients/cases. The performance data presented appears to be from bench testing or engineering validation studies comparing the IceSense3 to predicate devices.
   • There is no information about the country of origin or whether the data is retrospective or prospective, as it does not appear to be human clinical data.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable. The "ground truth" here is based on physical measurements of iceball size and temperature, not expert interpretation of clinical images or outcomes.

3. Adjudication method for the test set:

   • Not applicable, as there is no human interpretation involved in establishing the performance metrics.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No. This is not an imaging or diagnostic device with an AI component requiring MRMC studies.

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

   • Not applicable. This is a cryosurgical unit, not an algorithm. Its performance is inherent in its physical operation. The "performance data" provided evaluates the device's function directly.

6. The type of ground truth used:

   • The ground truth used for the performance evaluation appears to be physical measurements of iceball diameter, freezing time, and temperature, likely against established engineering specifications or the performance of predicate devices.

7. The sample size for the training set:

   • Not applicable. This is a medical device, not a machine learning algorithm that requires a "training set."

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

   • Not applicable. This is a medical device, not a machine learning algorithm.

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