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The Visual-ICE™ Cryoablation System is intended for cryoablative destruction of tissue during surgical procedures. 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 (with the exception of cardiac tissue), 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, and skin lesions.

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. Palliation of pain associated with metastatic lesions involving bone in patients who have failed or are not candidates for standard radiation therapy.

• 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 Cryoablation System is a mobile console system intended for cryoablative tissue destruction using a minimally invasive procedure. 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, using Boston Scientific's i-Thaw technology in which a heating element inside the cryoablation needle can be energized to cause thawing.

The provided document does not describe the acceptance criteria or a study that proves a device meets acceptance criteria in terms of an AI/ML algorithm's performance. Instead, it is a 510(k) summary for a medical device called the "Visual-ICE Cryoablation System," which is a cryosurgical tool.

The document discusses:

• Device Description and Intended Use: The Visual-ICE cryoablation system functions by applying extreme cold temperatures to destroy tissue, indicated for various surgical procedures, including specific indications for prostate tissue ablation, cancerous or malignant tissue ablation, and pain palliation for metastatic bone lesions.
• Non-Clinical Performance Testing: This section outlines verification and validation testing performed on the system itself (mechanical, electrical, software, labeling, packaging, and usability) to ensure it meets specified requirements and is substantially equivalent to a predicate device. This is about the cryoablation device's physical and functional performance, not an AI algorithm.
• Clinical Testing Summary (MOTION Study): This section details a clinical trial (MOTION) that evaluated the safety and effectiveness of the Visual-ICE Cryoablation System for pain palliation of metastatic lesions in bone. This is a clinical study on the efficacy of the medical device in treating a condition, not an AI model's diagnostic or predictive performance.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving an AI/ML device meets those criteria because the document describes a traditional medical device, not an AI/ML product.

To answer your specific questions in the context of the provided document, I'd have to reframe them to fit the subject matter, but that would go against the spirit of describing AI/ML device performance.

• No AI/ML algorithm performance study is described.
• No acceptance criteria for an AI/ML algorithm are given.

The "Acceptance criteria for all verification and validation testing" mentioned in the non-clinical section refer to the physical device's specifications (e.g., electrical safety, mechanical robustness), not an AI's diagnostic or predictive metrics. The "performance" in the clinical study refers to the effectiveness of the cryoablation system in achieving pain palliation.

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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.

Ask a specific question about this device

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.

Ask a specific question about this device

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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