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Galil Medical's IcePearl 2.1 CX and IceFORCE 2.1 CX Cryoablation Needle families are intended for cryoablative destruction of tissue during surgical procedures. The IcePearl 2.1 CX and IceFORCE 2.1 CX Cryoablation Needle families are 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, oncology, and urology. The systems are designed to destroy tissue by the application of extreme cold temperatures including prostate and kidney tissue, liver metastases, tumors, skin lesions, and warts.

The Galil Medical IcePearl 2.1 CX and IceFORCE 2.1 CX Cryoablation Needle families have 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)
• · 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,

dermatofibromas small hemanglomas, mucocele cysts, multiple warts, actinic and seborrheic keratoses, cavernous hemanglomas, perianal 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, hemorrhoids, anal fissures, pilonidal cysts, and recurrent cancerous lesions, ablation of breast fibroadenoma)

• · 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)

Galil Medical's IcePearl 2.1 CX, IceFORCE 2.1 CX, IcePearl 2.1 CX L, and IceFORCE 2.1 CX L Cryoablation Needles (collectively referred to as the 2.1 CX Cryoablation Needles) are sterile, single use, disposable components, when used in conjunction with Galil Medical's commercially available cryoablation systems, to perform cryoablative destruction of tissue. The needles are intended to convert high-pressure gas to either a very cold freezing application or to a warm thawing application.

The 2.1 CX Cryoablation Needles are disposable 2.1 mm needles that have a sharp cutting tip, a color-coded handle, a gas tube, and a connector. Both the IcePearl and IceFORCE needle families offer handles configured as straight and in a 90-degree angled configuration (to aid positioning of the needle within the CT imaging system gantry). Additionally, both needle families offer a long version of the needle that contains a longer needle shaft and a 90-degree angled handle configuration (IcePearl 2.1 CX L and IceFORCE 2.1 CX L).

The change presented in this Special 510(k) is an internal component change. There are no changes to the intended use, indications for use, or technological characteristics.

Here's an analysis of the provided text regarding the acceptance criteria and study information for the IcePearl 2.1 CX and IceFORCE 2.1 CX Cryoablation Needles.

Overall Assessment:

The provided document is a 510(k) Summary for a Special 510(k) submission. This type of submission is used when there are modifications to a legally marketed device that do not affect its intended use or fundamental scientific technology. The primary purpose of the testing described is to confirm that the changes made to the device (a component change) do not negatively impact its existing safety and performance characteristics and that it remains substantially equivalent to its predicate.

Therefore, the document does not contain information about a comprehensive clinical study to establish initial efficacy or performance against new acceptance criteria. Instead, it focuses on demonstrating that the modified device still meets the established performance specifications of the predicate devices.

Detailed Breakdown of Requested Information:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance

The document does not specify the exact sample sizes or the data provenance (e.g., country of origin, retrospective/prospective) for any of the performance tests. It states that "Verification and performance testing was conducted on needles built with the modified component." Given it's a Special 510(k) for a component change, the testing would likely involve a statistically appropriate number of units to demonstrate consistent performance within a manufacturing batch, rather than a large clinical trial.

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

This information is not applicable to this type of submission. The ground truth for this device's performance is based on engineering specifications and physical measurements (e.g., temperature, electrical resistance, freezing rates), not on expert clinical assessment or consensus.

4. Adjudication method for the test set

This information is not applicable. Since the testing is based on direct physical measurements against engineering specifications, there is no need for expert adjudication.

5. 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

This information is not applicable. The device is a cryosurgical needle, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance is irrelevant.

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

This information is not applicable. The device is a physical cryosurgical needle, not an algorithm.

7. The type of ground truth used

The ground truth for the performance testing of this cryoablation needle is based on engineering specifications and physical measurements. These specifications would have been established during the development and initial clearance of the predicate devices, covering aspects like target temperatures, freezing rates, electrical integrity, and material durability.

8. The sample size for the training set

This information is not applicable. The device is a physical medical instrument, not a machine learning algorithm that requires a training set.

9. How the ground truth for the training set was established

This information is not applicable for the same reason as above.

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The HEATfx Microwave Ablation System and Accessories are intended for the ablation (coagulation) of soft tissue in percutaneous, open surgical, and laparoscopic surgical settings.

The HEATfx Microwave Ablation System is not intended for use in cardiac procedures.

The HEATfx Microwave Ablation System is a mobile system intended to deliver microwave energy for thermal tissue ablation using a minimally invasive procedure. The HEATfx Microwave Ablation System is comprised of a console with optional cart, microwave ablation needles with cooling water manifold, optional thermal sensor, and related accessories.

The HEATfx console is computer-controlled with a touch screen user interface that allows the user to control and monitor the procedure. The HEATfx System utilizes three 2450 MHz, 145W generators to deliver microwave energy to up to three HEATfx Needles.

The HEATfx Microwave Ablation Needles are inserted into the target lesion under ultrasound or CT image guidance during laparoscopic procedures, or using direct visualization during surgical procedures, and operated using the console. The needles incorporate an antenna that transmits the microwave energy uniformly around the needle shaft. When connected to the HEATfx console, the console's internal pump and a disposable water manifold circulate sterile water through the needle for needle cooling and facilitating a uniform ablation zone.

The optional Multi-Point Thermal Sensor allows the user to monitor tissue temperatures near critical structures during an ablation procedure.

The system must be used with an irrigation baq of sterile water (not provided with the system).

The provided text describes the HEATfx Microwave Ablation System's 510(k) submission to the FDA. It does not contain information about the acceptance criteria or a study proving the device meets those criteria in the context of an AI/machine learning device.

The document focuses on the substantial equivalence of the HEATfx Microwave Ablation System to a predicate device (Emprint Ablation System) based on technological characteristics, performance data (system, mechanical, electrical, software, needle, thermal sensor, ex-vivo, in-vivo, biocompatibility, usability, packaging, sterility, pyrogenicity testing), and intended use.

Therefore, for the specific questions related to AI/ML device acceptance criteria and studies (such as sample sizes for test/training sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance), the provided text does not contain the necessary information.

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The ICEfx™ 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, oncology, proctology and urology. This System is designed to destroy tissue (including prostate and kidney tissue, liver metastases, tumors, 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
• . 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, dermatofibromas, small hemangiomas, mucocele cysts, multiple warts, plantar warts, actinic and seborrheic 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 Galil Medical CX technology in which a heating element inside the cryoablation needle can be energized to cause thawing.

The provided document is a 510(k) Premarket Notification summary for the ICEfx Cryoablation System. It focuses on demonstrating substantial equivalence to a predicate device, the Visual-ICE Cryoablation System (K113860), rather than proving independent effectiveness through a clinical study with detailed acceptance criteria and performance metrics typically associated with AI/ML device submissions.

Therefore, the information required to populate the requested table and answer the detailed questions about acceptance criteria, study design (sample size, data provenance, ground truth establishment, expert adjudication, MRMC studies, training set details), and specific performance metrics is not present in this document.

This submission is for a medical device that achieves its therapeutic effect through the application of extremely cold temperatures via a physical system (Joule-Thomson effect with argon gas), not through an AI/ML algorithm that predicts or diagnoses based on data. The "performance data" mentioned in the summary refers to engineering and verification/validation testing of the physical system, electrical components, and software, ensuring it functions as intended and meets safety standards, rather than evaluating interpretive accuracy (like an AI model).

Here's what can be extracted and why the rest cannot be answered:

1. A table of acceptance criteria and the reported device performance:

• Acceptance Criteria (Implicit): The document states that "A full battery of verification and validation testing was conducted... to ensure that the design, functionality, and performance met all the specified requirements." These "specified requirements" are the implicit acceptance criteria, but no specific quantitative metrics (e.g., "Cryoprobe reaches -X degrees Celsius within Y seconds" or "Iceball diameter of Z mm after T minutes") are provided in this summary.
• Reported Device Performance: The document generally states: "Test results demonstrated that the ICEfx Cryoablation System meets defined specifications..." It lists types of testing performed (system, electrical, mechanical, labeling, software, usability) but does not provide specific performance outcomes or values against defined criteria.

2. Sample sized used for the test set and the data provenance:

• Not applicable/Not provided. The "test set" here refers to the physical device undergoing engineering tests, not a dataset for an algorithm. There is no mention of "data provenance" in the context of clinical data for algorithmic evaluation.

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

• Not applicable/Not provided. This type of information is relevant for AI/ML devices where human expert consensus often establishes ground truth for image interpretation or diagnosis. For a cryoablation system, "ground truth" would be related to physical properties (e.g., temperature attained, iceball size), established by instrumentation and calibration, not human interpretation.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not applicable/Not provided. Adjudication is used for expert disagreements in clinical ground truth establishment, which isn't the focus of this device's testing.

5. 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 a physical cryoablation system, not an AI-assisted diagnostic tool. Therefore, MRMC studies are not relevant to its regulatory submission.

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

• Not applicable/Not provided. There is no "algorithm only" performance reported as this device is a physical cryosurgical tool. Its software controls the system, but it doesn't provide diagnostic outputs or interpretations that would be evaluated in a standalone manner.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• Not explicitly stated for the "test set" as it relates to performance; however, for a cryoablation system, ground truth for its physical performance would be based on instrumentation readings and measurements (e.g., temperature probes confirming freezing, imaging to measure iceball dimensions against known physical properties of ice formation).

8. The sample size for the training set:

• Not applicable/Not provided. This device does not use an AI model that requires a training set in the conventional sense.

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

• Not applicable/Not provided. Since there's no training set for an AI model, this question is not relevant.

In summary: The provided 510(k) summary is for a traditional medical device (cryoablation system) that demonstrates substantial equivalence through engineering verification and validation testing, not through a statistical evaluation of an AI algorithm's performance on clinical data or comparative effectiveness studies with human readers. Therefore, many of the questions asked, which are highly relevant to AI/ML device submissions, do not apply to this document.

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The Visual-ICE MRI 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 designed to destroy tissue (including prostate and kidney tissue, liver metastases, tumors, and skin lesions) by the application of extremely cold temperatures.

The Visual-ICE MRI 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
• 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, dermatofibromas, small hemangiomas, mucocele cysts, multiple warts, plantar warts, actinic and seborrheic 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 Visual-ICE™ MRI Cryoablation System is a mobile system intended for cryoablative tissue destruction using a minimally invasive procedure. The Visual-ICE MRI Cryoablation System has been designed to permit the delivery of cryoablation treatments under visual guidance in an MR environment. The Visual-ICE MRI System is comprised of a Console, Mobile Connection Panel (MCP) and a Junction Box Assembly. The system is computercontrolled with a touch screen user interface that allows the user to control and monitor the procedure. The console is located in the control room, while the Mobile Connection Panel is located in the magnet room. Junction boxes mounted in the two rooms, and connection of the gas and signal lines between the junction boxes occurs via a penetration panel. The Mobile Connection Panel is constructed of non-ferromagnetic materials to allow for placement within the magnet room close to the scanner. The Visual-ICE MRI Cryoablation System was designed for compatibility with Galil Medical's previously cleared IceRod MRI and IceSeed MRI cryoablation needles (K051052).

The provided text describes the Visual-ICE MRI Cryoablation System, which is a cryosurgical tool. However, the document is a 510(k) summary for a premarket notification to the FDA, focused on establishing substantial equivalence to predicate devices, not a study proving the device meets specific acceptance criteria in the context of an AI/ML device.

Therefore, the information required to populate the fields regarding acceptance criteria, study details, ground truth, and sample sizes for an AI/ML device is not present in the provided document. The document describes a medical device, which is an MRI Cryoablation System, and its purpose is to demonstrate its equivalence to previously cleared devices, not to present a performance study against specific acceptance criteria for an AI/ML component.

The document discusses Verification and Validation testing, including system, electrical, mechanical, packaging, labeling, and software testing, as well as design, usability, and animal testing. These are general engineering and medical device validation steps, not specific metrics for evaluating an AI/ML algorithm's performance.

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The Visual-ICE Cryoablation System is indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurology (including cryoanalgesia), thoracic surgery, ENT, gynecology, oncology, and urology. This system is designed to destroy tissue (including prostate and kidney tissue, liver metastases, tumors, skin lesions) by the application of extremely cold temperatures. The Visual-ICE 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
• · 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, dermatofibromas, small hemangiomas, mucocele cysts, multiple warts, actinic and seborrheic 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 the rectum, hemorrhoids, 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: Ablation of arrhythmic cardiac tissue cancerous lesions
• · Proctology: Ablation of benign or malignant growths of the anus or rectum, and hemorrhoids

The Visual-ICE Cryoablation System is a mobile console 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 Visual-ICE System uses high-pressure argon gas that circulates through closed-tip cryoablation needles to induce tissue freezing. Active tissue thawing is achieved by circulating helium gas through the needles or, alternatively, by the use of Galil Medical i-Thaw® technology in which a heating element inside the cryoablation needle can be energized to cause thawing.

This Special 510(k) is being submitted to modify the software with a variety of changes to enhance usability of the system. The functions of the system that users use to deliver the cryoablation treatment remain unchanged.

The provided text is a 510(k) Summary for the Visual-ICE® Cryoablation System, Software Revision 1.3.1. It describes a medical device and its intended use, but it does not contain information about acceptance criteria, device performance metrics, sample sizes for test or training sets, expert qualifications, adjudication methods, or comparative effectiveness studies (MRMC or standalone).

The document is a regulatory submission demonstrating substantial equivalence to a predicate device, focusing on software changes and their impact on safety and effectiveness. It states that "Software Revision 1.3.1 passed all verification and validation testing," implying that it met internal development and regulatory requirements, but it does not detail those specific acceptance criteria or the study data that proves the device meets them in terms of clinical performance.

Therefore, many of the requested elements cannot be extracted from this document.

Here's what can be inferred and what is explicitly not present:

1. Table of acceptance criteria and reported device performance:

• Acceptance Criteria: Not explicitly stated in terms of specific performance metrics or thresholds. The document implies an acceptance criterion of "passed all verification and validation testing" for the software changes, but no numerical or qualitative performance targets are provided.
• Reported Device Performance: Not reported in terms of clinical outcomes or specific performance metrics. The document states "no new unacceptable risks were identified" and "no changes were made to the Visual-ICE System hardware," focusing on the safety and functional integrity of the software update rather than clinical performance data.

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

• Sample Size for Test Set: Not specified. "Complete software verification and validation testing" was performed, but the size or nature of the test set (e.g., number of test cases, simulated procedures, or patient data if applicable) is not detailed.
• Data Provenance: Not specified. Given it's a software update for an existing device, testing likely involved internal simulations, unit tests, integration tests, and system-level tests. There is no mention of patient data (retrospective or prospective, or country of origin) being used for this specific software revision's validation.

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

• Not applicable/Not mentioned. The document describes software verification and validation, which typically involves engineering and quality assurance personnel, not clinical experts establishing ground truth for diagnostic or therapeutic accuracy in the same way an AI model for image interpretation would require.

4. Adjudication method for the test set:

• Not applicable/Not mentioned. Adjudication is relevant when multiple experts interpret data to establish a consensus ground truth. This type of process is not described for software verification and validation.

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

• No. This is not an AI-assisted diagnostic or therapeutic device that would involve human readers. The device is a cryoablation system, and this submission relates to a software update for its control system.

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

• No. This device is a cryoablation system, which is inherently a human-in-the-loop interventional device. The software update affects its control and usability. Standalone algorithm performance is not applicable in this context.

7. The type of ground truth used:

• Not explicitly defined in the context of clinical ground truth (e.g., pathology, outcomes data). For software verification, the "ground truth" would be the expected behavior/output as defined by the software requirements and design specifications. For example, if a timer should display "X" seconds, the ground truth is "X" seconds, and the test verifies that it does.

8. The sample size for the training set:

• Not applicable/Not mentioned. This is not a machine learning or AI device that requires a training set in the conventional sense. The software was developed and verified, not "trained."

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

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

In summary: The provided document is a regulatory statement for a software update to a cryoablation system. It confirms that the software passed internal verification and validation, thus maintaining substantial equivalence to previously cleared devices. However, it does not include the detailed performance study information typically associated with AI/ML-based diagnostic or therapeutic devices such as acceptance criteria based on accuracy/sensitivity/specificity, clinical test sets, expert ground truth establishment, or comparative effectiveness studies.

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The Visual-ICE™ Cryoablation System is intended for cryoablative destruction of tissue during surgical procedures. The Visual-ICE System 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 Visual-ICE 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)
• . 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, dermatofibromas small hemanglomas, mucocele cysts, multiple warts, plantar warts, actinic and seborrheic keratoses, cavernous hemanglomas, perianal condylomata, and palliation of tumors of the skin.)
• . Gynecology (ablation of malignant neoplasia or benign dysplasia of the female genitalia)
• . General surgery (palliation of the rectum, hemorrhoids, anal fissures, pilonidal cysts, and recurrent cancerous lesions, ablation of breast fibroadenoma)
• . ENT (Palliation of tumors of the oral cavity and ablation of leukoplakia of the mouth)
• Thoracic surgery (ablation of arrhythmic cardiac tissue cancerous lesions) .
• . Proctology (ablation of benign or malignant growths of the anus or rectum, and hemomhoids)

The Visual-ICE Cryoablation System is a mobile console 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 Visual-ICE System uses high-pressure argon gas that circulates through closed-tip cryoablation needles to induce tissue freezing. Active tissue thawing is achieved by circulating. helium gas through the needles or, alternatively, by the use of Galil Medical i-Thaw technology in which a heating element inside the cryoablation needle can be energized to cause thawing.

This Special 510(k) is being submitted to modify the software with a variety of changes to enhance usability of the system. These changes are primary being made to the user interface and the service and maintenance screens. Basic functionality of the system remains unchanged, however, the following functional modifications have been made:

• . Organ map display has been modified to allow users to place MTS needles on the Organ Мар,
• When all channels are locked and linked together the Test All button icon state identifies the . state for all channels.
• The software defaults all needles to the first 1-wire needle that was attached. .
• User interface can display up to three large timers instead of two. .
• Freeze-thaw cycles can now be programmed for all channels using the All button, .
• The software wams the user of low gas when the remaining gas time reaches 10 minutes . instead of 5 minutes,
• "Stick" intensity has been changed from 20% to 5%, .
• Helium low-pressure warning was reduced to 1800 PSI from 2100 PSI. .

Here's an analysis of the provided text regarding the acceptance criteria and study for the Visual-ICE® Cryoablation System, Software Revision 1.2.2:

This submission is a Special 510(k) for software modifications to an existing device (Visual-ICE® Cryoablation System, K113860). Special 510(k)s are for well-established devices where changes do not alter the fundamental scientific technology or intended use, and where performance can be verified through existing test methods. This typically means a full clinical study with acceptance criteria for the device's diagnostic performance (e.g., sensitivity, specificity) against a ground truth would not be required or presented in this type of submission. Instead, the focus is on verification and validation of the software changes to ensure they did not introduce new risks or negatively impact existing functionality.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size: Not applicable in the context of a diagnostic performance study, as this is a software update for a cryoablation system, not a diagnostic device. The "test set" here refers to the software verification and validation tests. The document states a "complete software verification test was conducted" but does not specify the number of individual test cases or scenarios.
• Data Provenance: Not applicable for a software verification study. The tests would have been performed by the manufacturer (Galil Medical Inc.) in a testing environment.

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

• Number of experts: Not applicable. The "ground truth" for a software verification study involves comparing the software's behavior against its functional specifications and requirements. This is typically established by software engineers and quality assurance personnel, not medical experts for a diagnostic assessment.

4. Adjudication method for the test set

• Adjudication method: Not applicable. Software verification involves testing against defined specifications. Test failures would be reported and addressed, but there isn't a "consensus" or "adjudication" process in the medical expert sense.

5. 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

• MRMC Study: No. This is not a diagnostic device with an AI component that assists human readers.

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

• Standalone Performance: Not applicable. This is a cryoablation system where the software controls the hardware and user interface for a medical procedure performed by a clinician. It's not an algorithm that performs a task autonomously in a "standalone" fashion such as diagnosing an image.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Type of Ground Truth: The "ground truth" for this software update is the software requirements specification and design documentation. The verification testing confirms that the software's behavior matches these predefined requirements.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This is not a machine learning or AI-driven system that requires a "training set."

9. How the ground truth for the training set was established

• Ground Truth for Training Set: Not applicable, as there is no training set for this type of software update.

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The Visual-ICE™ Cryoablation System is intended for cryoablative destruction of tissue during surgical procedures. The Visual-ICE System 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, lesions, and warts.

The Visual-ICE 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
• 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, dermatofibromas, small hemangiomas, mucocele cysts, multiple warts, plantar warts, actinic and seborrheic 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, hemorrhoids, 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 Ablation of arrhythmic cardiac tissue cancerous lesions
• Proctology Ablation of benign or malignant growths of the anus or rectum, and hemorrhoids

The Visual-ICE Cryoablation System is a mobile console 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 Visual-ICE System uses high-pressure argon gas that circulates through closed tip cryoablation needles to induce tissue freezing. Active tissue thawing is achieved by circulating helium gas through the needles or alternatively, by the use of Galil Medical i-Thaw technology in which a heating element inside the cryoablation needle can be energized to cause thawing.

The provided document is a 510(k) summary for the Visual-ICE™ Cryoablation System. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain specific acceptance criteria, detailed study results proving a device meets acceptance criteria, or information on AI/standalone performance. It primarily focuses on the device's technical specifications and intended clinical applications.

Therefore, I cannot provide the requested information about acceptance criteria and detailed study results from the provided text. The document states a "full battery of verification and validation testing was conducted" and that "Test results demonstrated that the Visual-ICE Cryoablation System meets defined specifications," but it does not explicitly list those specifications or provide the data from those tests.

Here's a breakdown of what can and cannot be extracted based directly on your request:

1. A table of acceptance criteria and the reported device performance

• Cannot provide. The document states that testing demonstrated the system "meets defined specifications" but does not enumerate these specifications or the exact performance results against them.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Cannot provide concrete details. The document mentions "animal cadaver testing" but does not specify the sample size, type of animals, or provenance. It does not mention any human data or the specifics of other testing (system, electrical, mechanical, etc.).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable/Cannot provide. The document does not describe the establishment of a "ground truth" for a test set in the context of diagnostic or AI performance evaluation. This device is a cryoablation system, a therapeutic device, not a diagnostic one.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable/Cannot provide. No mention of an adjudication process for a test set is made, as this is not a diagnostic device involving expert review of results.

5. 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, not applicable. The document describes a cryoablation system, which is a therapeutic device rather than an AI-powered diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device and no such study is mentioned.

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

• No, not applicable. This is a hardware cryoablation system, not an algorithm or AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not applicable. See points 3 and 4. The "ground truth" for a therapeutic device's performance would typically relate to its physical functionality (e.g., cooling efficacy, temperature control, mechanical reliability), not diagnostic interpretation.

8. The sample size for the training set

• Not applicable. No mention of a "training set" as this is not an AI/machine learning device.

9. How the ground truth for the training set was established

• Not applicable. No mention of a "training set" or its ground truth.

Summary of what the document does state regarding testing:

• Testing Conducted: A "full battery of verification and validation testing" including system testing, electrical testing, mechanical testing, packaging and labeling testing, software testing, design and usability testing, and animal cadaver testing.
• Outcome: "Test results demonstrated that the Visual-ICE Cryoablation System meets defined specifications, is substantially equivalent to the predicate device, and does not raise any new issues of safety and effectiveness."
• Predicate Device: Galil Medical's Presice Cryoablation System (K060390). The Visual-ICE System is stated to use "the same technology and has the same intended use and indications for use as the predicate."

In essence, the document confirms that testing was done to ensure the device met its requirements and was substantially equivalent, but it does not provide the granular details of those tests, specific acceptance criteria, or the results in a quantifiable manner as you've requested.

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Galil Medical Cryoablation Systems are intended for cryoablative destruction of tissue during surgical procedures. The cryoablation systems are 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 systems are designed to destroy tissue by the application of extreme cold temperatures including prostate and kidney tissue, liver metastases, tumors, skin lesions, and warts.

Galil Medical Cryoablation Systems have 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)
• . 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, dermatofibromas small hemanglomas, mucccele cysts, multiple warts, plantar warts, actinic and seborrheic keratoses, cavernous hemanglomas, perianal condylomata, and palliation of tumors of the skin.)
• . Gynecology (ablation of malignant neoplasia or benign dysplasia of the female genitalia)
• t General surgery (palliation of the rectum, hemorrhoids, anal fissures, pilonidal cysts, and recurrent cancerous lesions, ablation of breast fibroadenoma)
• . ENT (Palliation of tumors of the oral cavity and ablation of leukoplakia of the mouth)
• . Thoracic surgery (ablation of arrhythmic cardiac tissue cancerous lesions)
• t Proctology (ablation of benign or malignant growths of the anus or rectum, and hemorrhoids)

The IceEDGE 2.4 Cryoablation Needle is a sterile, single use, disposable component used in conjunction with a Galil Medical Cryoablation System when performing cryoablative destruction of tissue. It is intended to convert high-pressure gas to either a very cold freezing application or to a warm thawing application. The disposable cryoablation needle has a sharp cutting tip, a 2.4 mm shaft, a color-coded handle, gas tubing, and a connector. Additionally, the needle shaft exhibits markings every 5 mm to aid in positioning the needle in tissue. The IceEDGE needle differs from the predicate devices in that it contains modified heat exchanger and a larger shaft diameter to enable the needle to produce a larger iceball size.

This document is a 510(k) summary for the IceEDGE 2.4 Cryoablation Needle. It describes the device, its intended use, and claims substantial equivalence to predicate devices based on performance testing.

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

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document mentions "Performance testing was conducted on IceEDGE Cryoablation Needle," but does not specify the sample size used for any of the tests (dimensional, functional, freezing performance, or in vivo ablation zone characterization).

The data provenance is not explicitly stated. However, the testing was conducted in-house by Galil Medical Ltd., and it is implied to be prospective as it was conducted specifically for this 510(k) submission. There is no mention of country of origin for the data beyond that it was conducted by the submitter (Galil Medical Ltd. in Israel).

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

This information is not provided in the document. The document refers to "in vivo ablation zone characterization," which would typically involve expert interpretation (e.g., by pathologists or radiologists). However, the number and qualifications of such experts are not detailed.

4. Adjudication Method for the Test Set:

This information is not provided in the document.

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

This study was not done. The document describes performance testing of the device itself and compares its technical specifications and intended use to predicate devices, but it does not involve human readers for comparative effectiveness.

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

This concept does not apply to this device. The IceEDGE 2.4 Cryoablation Needle is a physical medical device (a cryoablation needle), not an algorithm or AI software. Therefore, a standalone algorithm performance study is not relevant.

7. Type of Ground Truth Used:

For the in vivo ablation zone characterization, the ground truth would likely be histopathological or imaging-based assessment by experts (e.g., pathology reports or radiological interpretations of ablation zones). However, the document only broadly states "in vivo ablation zone characterization" without specifying the precise method of ground truth establishment. For other tests (dimensional, functional, freezing), the "ground truth" would be the device specifications themselves (e.g., a specific length, a certain gas flow rate, a measured iceball diameter).

8. Sample Size for the Training Set:

This information is not applicable as this is a physical medical device and not an AI/ML algorithm that requires a training set.

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

This information is not applicable as this is a physical medical device and not an AI/ML algorithm.

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