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The Galil Medical 1.5 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures. The 1.5 CX Cryoablation Needles, when used with a Galil Medical Cryoablation System, are designed to destroy tissue by the application of extremely cold temperatures. A full list of specific indications can be found in the respective Galil Medical Cryoablation System User Manual.

For reference, the indications for use from Galil Medical Cryoablation Systems User Manuals are provided below.

The Galil Medical Cryoablation Systems 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 (including prostate and kidney tissue, liver metastases, tumors, skin lesions) by the application of extremely cold temperatures. The 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 evelid 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 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 IceSphere 1.5 CX Cryoablation Needle is a sterile, single use, disposable component, used in conjunction with a Galil Medical Cryoablation System to perform cryoablative destruction of tissue. The needle is intended to convert high-pressure gas to either a very cold freezing application or to a warm thawing application. Galil Medical's IceSphere 1.5 CX Cryoablation Needle is a disposable 1.5 mm needle that have a sharp cutting tip, a color-coded handle, a gas tube, and a connector. The IceSphere 1.5 CX Cryoablation Needle offers a handle configured in a 90° angled configuration (to aid positioning of the needle within the CT imaging system gantry).

This document is an FDA 510(k) Premarket Notification for the "IceSphere 1.5 CX Cryoablation Needle." It does not describe a study involving an AI/machine learning device or a comparative effectiveness study involving human readers and AI. Instead, it details the substantial equivalence of a new medical device (a cryoablation needle) to existing predicate devices.

Therefore, many of the requested criteria regarding AI model performance, human expert adjudication, MRMC studies, and ground truth establishment for AI training/testing sets are not applicable to the information contained in this document.

The document focuses on demonstrating that the new cryoablation needle has the same technology, principle of operation, indications for use, and performance characteristics as previously cleared devices. The "performance data" referred to are related to the physical and functional aspects of the needle itself, not to the diagnostic or predictive performance of an AI algorithm.

Summary of what can be extracted based on the provided document:

There is no information in this FDA 510(k) Premarket Notification that pertains to the acceptance criteria or study design for an Artificial Intelligence or Machine Learning (AI/ML) device. This document is for a cryoablation needle, a physical medical device, not an AI software. Therefore, the requested information elements (acceptance criteria for AI, sample sizes for AI test/training sets, expert ground truth establishment, MRMC studies, standalone AI performance) are not applicable to this submission.

The "Summary of Performance Data and Substantial Equivalence" section in the document refers to:

• Functional testing: Assessed electrical heater requirements and functional requirements of the needle.
• System compatibility testing: Ensured the needle would operate with the Galil Medical Cryoablation System.
• Labeling verification: Evaluated instructions for use and labeling accuracy.

These tests prove the physical device (the cryoablation needle) meets its specifications and performs equivalently to predicate devices, not that an AI model meets performance criteria.

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Galil Medical's IcePearl 2.1 CX L and IceFORCE 2.1 CX L Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures. The IcePearl 2.1 CX L and IceFORCE 2.1 CX L Cryoablation Needles are indicated for use as a cryosurgical tool in the fields of general surgery, dermatology (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 L and IceFORCE 2.1 CX L Cryoablation Needles 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, and hemorrhoids)

Galil Medical's IcePearl 2.1 CX L and IceFORCE 2.1 CX L Cryoablation Needles are sterile, single use, disposable components, when used in conjunction with Galil Medical's Visual-ICE Cryoablation System 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 IcePearl 2.1 CX L and IceFORCE 2.1 CX L Cryoablation Needles are disposable 2.1 mm needles that have a sharp cutting tip, a color-coded handle, a gas tube, and a connector. The IcePearl 2.1 CX L and IceFORCE 2.1 CX L Cryoablation Needles offer handles configured in a 90° angled configuration.

The IcePearl 2.1 CX L and IceFORCE 2.1 CX L Cryoablation Needles were designed to provide the same cryoablation functionality with the same iceball shapes as compared to Galil Medical's predicate needles, IcePearl 2.1 CX and IceFORCE 2.1 CX (K152133).

The new devices differ from the predicate devices in that the needle shaft is 55 mm longer than the needle shaft of the predicate devices. The longer shaft length was incorporated into the needles to treat deep-seated tumors in patients with a larger body habitus, while still allowing for CT gantry clearance using a 2.1 CX type needle.

The provided text describes the 510(k) summary for the IcePearl 2.1 CX L and IceFORCE 2.1 CX L Cryoablation Needles. This document primarily focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and a study to prove performance against those criteria in the way one might expect for a novel device or a standalone AI algorithm.

Based on the provided text, the device itself is a physical medical instrument (cryoablation needles), not an AI-powered diagnostic or treatment planning system. Therefore, many of the requested points regarding AI device studies (e.g., sample size for test set, data provenance, ground truth experts, MRMC studies, standalone performance, training set details) are not directly applicable in the context of this 510(k) submission.

However, I can extract information related to the device and its performance testing as presented in the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of numerical acceptance criteria with corresponding performance values in the way you might see for an AI algorithm (e.g., sensitivity, specificity thresholds). Instead, for a medical device like a cryoablation needle, acceptance is demonstrated by showing "same as predicate" or "meets defined specifications" through performance testing.

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is detailed as "Performance testing... with the previously cleared Visual-ICE System Software to verify safety and performance characteristics and to establish substantial equivalence." This testing included "freezing and in vivo performance." The outcome was that "Test results demonstrated that the IcePearl 2.1 CX L and IceFORCE 2.1 CX L Cryoablation Needles meet defined specifications and do not raise any new safety or effectiveness issues."

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

• Sample Size for Test Set: Not specified in the provided text. The testing conducted included "freezing and in vivo performance," implying physical or biological testing, but the number of units tested or subjects in vivo is not given.
• Data Provenance: Not explicitly stated. The testing was described as "in-house requirements" and "according to protocols based on international standards," which suggests laboratory and potentially animal or human (if "in vivo" refers to human trials, which is unlikely for a 510(k) for a device modification of this nature) testing. Given Galil Medical Ltd. is based in Israel, some testing might have been conducted there.

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

This question is not applicable as the device is a physical cryoablation needle, not a diagnostic or AI device that requires expert ground truth for interpretation. Ground truth for its performance would be physical measurements of iceball size, temperature, consistency, and in vivo effects, not expert medical opinion on images or data.

4. Adjudication method for the test set:

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth from multiple human readers for AI diagnostic studies. The performance of a physical device like a cryoablation needle is evaluated by direct measurement and observation, not by adjudicating expert opinions.

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:

Not applicable. This is not an AI device.

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

Not applicable. This is not an AI device.

7. The type of ground truth used:

For a physical medical device like this, the "ground truth" would be the direct physical and biological effects observed during testing. This would include:

• Physical measurements of iceball dimensions, temperatures, and freezing/thawing parameters in simulated environments.
• Histopathological (pathology) assessment of ablated tissue in in vivo studies.
• Direct observation of device function and integrity.

The text vaguely refers to "freezing and in vivo performance," which would be assessed against established physical or biological metrics.

8. The sample size for the training set:

Not applicable. This is not an AI device that requires a training set in the sense of machine learning.

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

Not applicable. This is not an AI device.

In summary, the document describes a 510(k) clearance for cryoablation needles that are substantially equivalent to a predicate device, with the primary difference being a longer needle shaft. The "study"
referred to is performance testing (including freezing and in vivo performance) to confirm that the longer needles maintain the same functional characteristics and safety profile as the predicate. The criteria are largely based on equivalence to the predicate and meeting defined internal specifications.

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Galil Medical's IcePearl 2.1 CX and IceFORCE 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures. The IcePearl 2.1 CX and lceFORCE 2.1 CX Cryoablation Needles 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, 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.

The Galil Medical IcePearl 2.1 CX and IceFORCE 2.1 CX Cryoablation Needles 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 cvsts, 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 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, and hemorrhoids)

Galil Medical's IcePearl 2.1 CX and IceFORCE 2.1 CX Cryoablation Needles are sterile, single use, disposable components, when used in conjunction with Galil Medical's Visual-ICE Cryoablation System Software Revision 1.4.0, 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 IcePearl 2.1 CX and IceFORCE 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 IcePearl 2.1 CX and IceFORCE 2.1 CX Cryoablation Needles offer handles configured as straight and in a 90° angled configuration (to aid positioning of the needle within the CT imaging system gantry).

The IcePearl 2.1 CX and IceFORCE 2.1 CX Cryoablation Needles were designed to provide the same cryoablation functionality with similar iceball shapes on a 2.1 mm shaft as compared to Galil Medical's predicate needles, IceRod CX (1.5 mm) needle and IceEDGE 2.4 mm needle.

The IcePearl 2.1 CX and IceFORCE 2.1 CX Crvoablation Needles differ from the predicate devices in that the reconfigured heat exchanger has been relocated from the needle shaft to the needle handle and an additional vacuum insulated tube has been incorporated into the handle. The changes were made to ensure optimal freezing performance utilizing a 2.1 mm shaft.

This Special 510(k) also contains changes to the Visual-ICE System software denoted as Software Release 1.4.0. Software Release 1.4.0 is an updated version of the Visual-ICE software previously cleared. There are no changes to the system hardware required as a result of the changes being made in the software. The following modifications were incorporated based on the added software support of the proposed IcePearl 2.1 CX and IceFORCE 2.1 CX Cryoablation Needles as well as customer and sales feedback to enhance the robustness of the software programming.

The provided text describes a 510(k) premarket notification for Galil Medical's IcePearl 2.1 CX and IceFORCE 2.1 CX Cryoablation Needles. This document is a regulatory submission for a medical device and, therefore, focuses on demonstrating substantial equivalence to existing predicate devices rather than proving a device meets specific acceptance criteria through a clinical study as would be done for AI/ML devices.

The information provided does not include:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for a test set or data provenance for such a test set.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for a test set.
• A multi-reader multi-case (MRMC) comparative effectiveness study, nor effects size of human readers with/without AI assistance.
• A standalone (algorithm only) performance study.
• The type of ground truth used (e.g., expert consensus, pathology, outcomes data).
• Sample size for a training set.
• How ground truth for a training set was established.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices. Here's what is reported about the device and its performance testing:

Device Description and Comparison to Predicates:

• Device Name: IcePearl 2.1 CX and IceFORCE 2.1 CX Cryoablation Needles
• Predicate Devices: IceRod CX Cryoablation Needles (K121251 and K140584), IceEDGE 2.4 Cryoablation Needle (K111859), Visual-ICE Cryoablation System (K113860, K123865, K143564).
• Key Differences of Submitted Device from Predicates:
  • Reconfigured heat exchanger relocated from the needle shaft to the needle handle.
  • Incorporation of an additional vacuum insulated tube in the handle.
  • Needle shaft size is in-between the shaft sizes of the predicates (IceRod CX is 1.5mm, IceEDGE 2.4mm).
• Similarities to Predicates: Needle tip, gas pathway tubing, needle connector, freezing/thawing technology, function, freezing parameters, thaw parameters, track ablation, and indications for use.
• Software Changes: Visual-ICE System Software Revision 1.4.0 (updated from previously cleared version) to support the new needles and enhance robustness based on customer feedback. Changes include user interface updates, service/maintenance features, functional changes (e.g., support for heated wire temperature info, 2.1 CX needles, timeline reporting, lowest temperature display), and combined UI/functional changes (e.g., real-time power consumption feedback, easier timer activation, streamlined channel controls, fast thaw direct access, save/load programmed cycles).

Study/Testing Information (Summary of Performance Data):

• Purpose of Testing: To verify safety and performance characteristics and to establish substantial equivalence.
• Type of Testing: Performance testing was conducted on the IcePearl 2.1 CX and IceFORCE 2.1 CX Cryoablation Needles with Visual-ICE Software Revision 1.4.0.
• Testing Methodologies: Testing was conducted according to protocols based on international standards and in-house requirements.
• Specific Tests Mentioned:
  • Dimensional testing
  • Functional testing
  • Freezing performance
  • In vivo needle track ablation, based on depth of tissue necrosis characterization.
• Results: "Test results demonstrated that the IcePearl 2.1 CX and IceFORCE 2.1 CX Cryoablation Needles when used with Visual-ICE Software Revision 1.4.0 meet defined specifications and do not raise any new safety or effectiveness issues."

In summary, the document states that performance testing was performed to demonstrate that the new needles, in conjunction with the updated software, meet defined specifications and are substantially equivalent to existing devices. However, it does not detail specific acceptance criteria or provide a table of performance metrics against those criteria. The focus is on verifying that the changes do not introduce new safety or effectiveness concerns compared to the already cleared predicate devices.

Ask a specific question about this device

Galil Medical Cryoablation Systems are intended for cryoablative destruction of tissue during surgical procedures. The cryoablation systems is indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurology (including cryoanalgesia), thoracic surgery, ENT, gynecology, 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.

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 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, 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

Galil Medical's predicate IceSphere needles and Galil's proposed IceSphere needles are sterile, single use, disposable devices used in conjunction with Gali! Medical's cleared cryoablation systems (SeedNet, SeedNet Gold; Presice; Visual-ICE) for cryoablative destruction of tissue during surgical procedures. The needles have a sharp cutting tip, a 1.5mm (17G) shaft, a color-coded handle, gas tubing, and a connector. Galil's predicate and proposed iceSphere needles are available in 2 handle configurations: straight and 90°. The needles contain shaft markings to aid the physician in needle placement.

Galil is requesting clearance of the proposed vacuum insulated IceSphere needles. The vacuum insulated modification represents a one-for-one component exchange within the internal non-patient contacting lumen of the cryoablation needle shaft.

The provided text is a 510(k) summary for the Galil Medical IceSphere Cryoablation Needle. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain information regarding traditional acceptance criteria, a test set with ground truth, or details of a study with human readers or standalone AI performance.

Instead, the performance data discussed pertains to engineering verification testing to demonstrate that the modified device (with vacuum insulation) meets design specifications compared to the predicate non-insulated device.

Therefore, many of the requested fields cannot be filled based on the provided document.

Here's a breakdown of what can be extracted and what cannot:

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

The document states: "The insulated IceSphere successfully passed all the design properties testing in accordance with the established acceptance criteria compared to the non-insulated IceSphere predicate. Test results demonstrated that the proposed insulated IceSphere needles meet defined specifications and do not raise any new safety or effectiveness issues as compared to the predicate."

This implies that the acceptance criteria were defined as the modified device performing equivalently to the predicate device in design properties testing. Specific numerical acceptance criteria or performance metrics are not provided.

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

This document describes engineering verification tests on the device itself, not a clinical study on patient data. Therefore, typical "test set" and "data provenance" as applied to AI/diagnostic devices are not applicable and not provided.

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)

This is not a diagnostic device or a study requiring expert readers for ground truth. This information is not applicable and not provided.

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

This is not a diagnostic device or a study requiring adjudication. This information is not applicable and not provided.

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 is not a diagnostic device or a study involving human readers or AI assistance. This information is not applicable and not provided.

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

This is not an algorithm or AI device. This information is not applicable and not provided.

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

Given this is an engineering verification of a physical medical device (cryoablation needle), the "ground truth" would be objective engineering measurements and comparisons to design specifications and the predicate device's measured performance. No clinical "ground truth" like pathology or outcomes data is relevant for the reported testing. This information is not applicable in the traditional sense of diagnostic AI.

8. The sample size for the training set

This document does not describe the development of an AI algorithm with a training set. This information is not applicable and not provided.

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

This document does not describe the development of an AI algorithm with a training set. This information is not applicable and not provided.

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The Galil Medical IceRod CX Cryoablation Needle is intended for cryoablative destruction of tissue during surgical procedures. The IceRod CX Cryoablation Needle 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 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 IceRod CX Cryoablation Needle 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 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, and hemorrhoids)

Galil is requesting clearance of a laser marking process improvement technique used to create the "markings" on the needle shaft of the previously cleared IceRod CX Needle (K121251). Galil's IceRod CX Needle (K121251) is a sterile, single use, disposable component used in conjunction with Galil Medical's Visual-ICE Cryoablation System (K113860, K123865) when performing cryoablative destruction of tissue. The needle has a sharp cutting tip, a 1.5mm (17G) shaft, a color-coded handle, gas tubing, and a connector. The handle is in a 90° configuration to aid positioning of the needle within the CT imaging system gantry. The IceRod CX needle contains shaft markings to aid the physician in needle placement. There are no changes to the marking dimensions on the needle. Only the marking technique has been modified.

Since Galil is requesting clearance for a revised shaft marking process improvement technique for the IceRod CX Cryoablation Needle design itself (with the exception of the shaft marking method) has not changed. There are no other design, specification, process, or material changes to the needle; additionally, the model number of the needle is unchanged.

This document is a 510(k) summary for the IceRod CX Cryoablation Needle, focusing on an improved laser marking process for the needle shaft. It primarily establishes substantial equivalence to a previously cleared device (K121251) rather than presenting a detailed clinical study with acceptance criteria in the typical sense for a brand new device or algorithm.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, sample size for training set, ground truth for training set) are not applicable to the type of submission described. This submission is for a process improvement to an existing device, not a new diagnostic or therapeutic algorithm.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in the typical format of a new medical device submission (e.g., sensitivity, specificity, accuracy thresholds). Instead, the acceptance criteria are implicit in demonstrating that the new laser marking process does not negatively impact the needle's integrity, safety, or performance characteristics compared to the predicate device.

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

• Sample Size: Not explicitly stated as a "test set" in the context of clinical performance. The document describes "shaft qualification testing," "heat affected zone measurements," and "shaft marking quality and adherence to specifications." The specific number of needles tested for these engineering/bench tests is not provided.
• Data Provenance: Not applicable in the context of clinical data. It's bench testing data conducted by Galil Medical.

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

Not applicable. Ground truth, in the sense of expert consensus on medical findings, is not relevant for this engineering-focused submission. The "ground truth" here is adherence to engineering specifications and performance parameters.

4. Adjudication method for the test set

Not applicable. No expert adjudication process is described.

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

Not applicable. This submission is for a medical device (cryoablation needle), not an AI/CAD device, and therefore, an MRMC study is not relevant.

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

Not applicable. This is not an algorithm or AI device.

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

The "ground truth" for this submission is based on engineering specifications, performance metrics, and safety standards derived from the predicate device and established manufacturing/quality control processes. This involves physical measurements, stress tests, and evaluations against pre-defined limits for mechanical integrity, thermal properties, and visual quality of the markings.

8. The sample size for the training set

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

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

Not applicable.

Ask a specific question about this device

The Galil Medical IceRod CX Cryoablation Needle is intended for cryoablative destruction of tissue during surgical procedures. The IceRod CX Cryoablation Needle 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 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 IceRod CX Cryoablation Needle 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 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, and hemorrhoids)

The IceRod CX Cryoablation Needle is a sterile, single use, disposable component used in conjunction with Galil Medical's Visual-ICE 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 IceRod CX disposable cryoablation needle has a 17G shaft, a sharp cutting tip, a color-coded handle, a gas tube, and a connector containing a small PCB board capable of relaying needle information such as needle type, lot number, and expiration date information to Galil's Visual-ICE Cryoablation System. Additionally, the needle exhibits markings to aid in positioning the needle in tissue. The IceRod CX needle differs from the predicate devices in that the distal shaft of the needle contains a non-stick coating and Galil's i-Thaw electrical thaw technology can be used for FastThaw and/or Track Ablation following a cryoablation procedure when used with Galil's Visual-ICE Cryoablation System.

The provided text describes the IceRod CX Cryoablation Needle and its substantial equivalence to predicate devices, focusing on design differences and intended use rather than specific acceptance criteria or a detailed study plan to demonstrate device performance against such criteria. Therefore, much of the requested information cannot be extracted directly from the given document.

Here's a breakdown of what can be inferred and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance results in a quantitative manner. It states that "Performance testing was conducted on IceRod CX Cryoablation Needle to verify safety and performance characteristics and to establish substantial equivalence. Testing was conducted according to protocols based on international standards and in-house requirements and included dimensional testing, functional testing, freezing performance, and in vivo needle track ablation, based on depth of tissue necrosis characterization." It concludes that "Test results demonstrated that the IceRod CX needle meets defined specifications and does not raise any new safety or effectiveness issues."

However, specific acceptance criteria values (e.g., maximum freezing temperature, ice ball size, thaw rate) and the measured performance metrics are not provided.

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

• Sample Size for Test Set: Not explicitly stated. The document mentions "in vivo needle track ablation" which implies an animal or cadaver study, but the number of needles or test subjects is not provided.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective). The in vivo nature suggests prospective experimental testing.

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

Not mentioned in the document.

4. Adjudication Method for the Test Set

Not mentioned in the document.

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

No, an MRMC comparative effectiveness study is not mentioned. This type of study is more relevant for diagnostic imaging devices where human readers interpret output, not for a cryoablation needle's performance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is not applicable as the device is a cryoablation needle, not an algorithm or AI system. Its performance is related to its physical and thermodynamic properties, not an algorithm's output.

7. The Type of Ground Truth Used

The "ground truth" for the performance testing cited appears to be based on:

• Defined specifications: For dimensional, functional, and freezing performance.
• Depth of tissue necrosis characterization: For in vivo needle track ablation, likely determined through histological examination or similar scientific assessment in a lab setting.
• ISO 10993 requirements: For biocompatibility, involving standardized tests.

8. The Sample Size for the Training Set

This question is not applicable as the device is a cryoablation needle, not an AI or machine learning model that requires a training set.

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

This question is not applicable as the device is a cryoablation needle, not an AI or machine learning model that requires a training set.

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Galil Medical Cryoablation Systems are intended for cryoablative destruction of tissue during surgical procedures. The cryoablation systems 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.

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 turnors, and palliative intervention)
• . Dermatology (ablation or freezing of skin cancers and other cutaneous disorders. Destruction of warts or lesions, angiomas, sebaceous hyperplasia, basal cell turnors 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 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 (ablation of arrhythmic cardiac tissue cancerous lesions)
• . Proctology (ablation of benign or malignant growths of the anus or rectum, and hemorrhoids)

The IceRod Plus 17G Cryoablation Needles are sterile, single use, disposable components used in conjunction with a Galil Medical Cryoablation System when performing cryoablative destruction of tissue. They are intended to convert high-pressure gas to either a very cold freezing application or to a warm thawing application. The IceRod Plus needles are available in two configurations, straight and angled 90°. Each 17-gauge (17G) disposable cryoablation needle has a sharp cutting tip, a shaft, a color-coded handle, a gas tube, and a connector. Additionally, each needle exhibits markings every 5 mm to aid in positioning the needle in tissue. The IceRod Plus needles differ from the predicate device in that they contain an inner vacuum insulated tube to provide additional shaft insulation during a cryoablation procedure.

The provided text describes a 510(k) summary for the "IceRod Plus 17G Cryoablation Needles" and a letter from the FDA. This document is a premarket notification for a medical device and, as such, focuses on demonstrating substantial equivalence to a predicate device rather than conducting extensive clinical studies with specific acceptance criteria and detailed performance metrics as might be found for novel devices or software.

Based on the information provided, here's a breakdown:

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

The document does not explicitly present a table of acceptance criteria with numerical targets and corresponding device performance data in the typical sense of a clinical trial or performance study for a diagnostic device. Instead, it describes various types of testing conducted to ensure the device meets specifications and is substantially equivalent to predicate devices. The "reported device performance" is a general statement that the device met these specifications, rather than a specific metric.

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

The document does not specify exact sample sizes for the testing set beyond implying that "performance testing was conducted on the IceRod Plus Cryoablation Needles" (plural, suggesting more than one, but not a defined number). There is no information provided about the data provenance (e.g., country of origin, retrospective or prospective) for these performance tests. This typically involves in-house laboratory testing rather than human subject data for this type of device.

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)

This information is not applicable to the type of device and testing described. The "ground truth" for cryoablation needles would be their physical and functional characteristics (e.g., dimensions, temperature output, biocompatibility), which are evaluated against engineering specifications and international standards, not typically established by clinical experts in the way ground truth is for diagnostic AI.

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

This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies where human reviewers independently assess data and resolve discrepancies, typically for diagnostic or clinical outcome measures. The testing described for the IceRod Plus is product performance testing against engineering and regulatory standards.

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

There is no indication that an MRMC comparative effectiveness study was conducted, nor is this type of study typically expected for a cryoablation needle. MRMC studies primarily evaluate the impact of a diagnostic AI system on human reader performance. The IceRod Plus is a medical device (a needle) used by a clinician during a procedure, not a diagnostic AI.

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

This information is not applicable. The IceRod Plus is a physical medical device, not an algorithm.

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

The "ground truth" for the performance testing mentioned (dimensional, functional, freezing performance, stability, biocompatibility) would be defined by engineering specifications, international standards (e.g., ISO 10993 for biocompatibility), and in-house requirements. It is not derived from expert consensus, pathology, or outcomes data in the clinical sense, but rather from measurable physical and performance characteristics.

8. The sample size for the training set

This information is not applicable. The IceRod Plus 17G Cryoablation Needle is a physical medical device, not an AI or machine learning model 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 point 8.

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The Isis System is intended for cryogenic destruction of tissue during surgical procedures. The Isis 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 Isis 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 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 (ablation of arrhythmic cardiac tissue cancerous lesions)
• Proctology (ablation of benign or malignant growths of the anus or rectum, and hemorrhoids)

Cryosurgical unit with argon-cooled probes

The provided text is a 510(k) summary for the Galil Medical Ltd. Isis™ System, a cryosurgical unit. It primarily focuses on the device's classification, predicate devices, and indications for use.

Crucially, this document does not contain information regarding:

• Acceptance criteria for device performance.
• Studies proving the device meets acceptance criteria.
• Device performance results.
• Sample sizes for test or training sets.
• Data provenance.
• Number or qualifications of experts for ground truth.
• Adjudication methods.
• MRMC comparative effectiveness studies.
• Standalone performance studies.
• Type of ground truth used.
• How ground truth was established.

The document is a regulatory approval summary, confirming the device's substantial equivalence to predicate devices for marketing purposes. It does not delve into the detailed technical performance or validation studies typically required for the information requested.

Therefore, I cannot provide the requested table and study details based on the provided input.

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The Presice system is intended for cryogenic destruction of tissue during surgical procedures. The Presice 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 Presice 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 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 (abla no cardiat tissue cancerous lesions)
• Proctology (ablation of benign or malignant growths of the anus or rectum, and hemorrhoids)
  The Presice System may be used with an ultrasound device to provide real-time visualization of the cryosurgical procedure.

Presice is a cryosurgical unit with argon-cooled probes. The principle changes between the Presice and the predicate SeedNet Family System include: Addition of new Electrical Thaw capability (i-Thaw™), enabling a choice between two thaw operating modes, Electrical or Helium Thaw. The new Electrical Thaw mode is supported by the use of new IceRod and SeedNet Cryo Needles, the IceSeed™ i-Thaw™ and the IceRod™ i-Thaw™ comprised of a new electrical thaw mechanism in addition to the Helium based thaw mechanism used in the cleared SeedNet Family Needles. Addition of a Multi-Thermal Sensor (MTS). Addition of touch screen user interface, thermal printer, USB port and frame grabber. Change of the software programming language from LabView to C++ and C#, while implementing the changes required to support the new electrical thaw feature and improving the user interface. In addition, the company has updated the operating system to Windows XP Pro, developers environment to .NET Framework and added certain off-the-shelf software (including drivers for the touch screen, thermal printer, USB port and frame grabber) for improved system functionality. Addition of a new name, the Presice™.

The provided text describes the Presice™ cryosurgical unit and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study that proves the device meets those criteria in the context of AI/ML performance.

Instead, the document focuses on:

• Regulatory details: Applicant information, device classification, predicate devices, and FDA approval.
• Intended Use: Broad applications of the cryosurgical unit across various medical fields.
• Performance Data & Substantial Equivalence: This section explains the changes made to the Presice system compared to its predicate (e.g., electrical thaw, multi-thermal sensor, software updates, new UI). It then states that the device was subjected to comprehensive testing to verify its safety and performance and demonstrate equivalency. However, it does not detail specific acceptance criteria, test methodologies, or results for metrics typically associated with AI/ML systems (e.g., accuracy, sensitivity, specificity, AUC). The "performance testing" mentioned is general and likely refers to engineering and functional performance, not clinical performance metrics for an AI-driven diagnosis or prediction.
• FDA Correspondence: Official letters confirming substantial equivalence.

Therefore, I cannot provide the requested information regarding acceptance criteria, reported device performance, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details as these are not present in the provided text.

The closest information related to "performance" is the general statement: "Test results demonstrated that the Presice system meets its specifications and does not raise any new safety and/or effectiveness issues." This implies internal functional and safety specifications were met, but these are not the "acceptance criteria" you're inquiring about for an AI/ML product.

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The SeedNet System is intended for cryogenic destruction of tissue during surgical procedures. The SeedNet 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 SeedNet System has the following specific indications:

• Urology (ablation of prostate tissue in cases of prostate cancer and t Benign Prostate Hyperplasia "BPH")
• Oncology (ablation of cancerous or malignant tissue and benign I 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 I the female genitalia)
• General surgery (palliation of tumors of the rectum, hemorrhoids, ı 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 hemorrhoids)

Cryosurgical unit with argon-cooled probes. The SeedNet Family System includes the SeedNet®/SeedNetGold® System, CryoThera® System, and Cryo-Hit® System. Modifications include the addition of a longer 17G (1.5mm) needle, a 90° needle, a needle/TS holder stand, and the addition of CT as an imaging modality to the device labeling, in addition to MRI and ultrasound.

Please find below the requested information based on the provided text.

Acceptance Criteria and Device Performance:

The document indicates that the modified SeedNet Family underwent a "comprehensive testing process as part of the design verification process." This implies that specific acceptance criteria were defined for these tests. However, the document does not explicitly state what these acceptance criteria were or provide detailed quantitative performance results against them. It broadly states that the device is "substantially equivalent in all aspects, e.g., technological characteristics, mode of operation, performance characteristics, intended use, etc., to the commercially available SeedNet Family."

Therefore, for the table, since specific numerical acceptance criteria and reported performance values are not provided, I will use the descriptive information available.

• Longer 17G (1.5mm) needle (modification of cleared 1.5mm stainless steel cryoneedle).
• 90° needle (modification of cleared 1.5mm stainless steel cryoneedle).
• Needle/TS holder stand.
• CT as an imaging modality in labeling (in addition to MRI and ultrasound).
  Deemed substantially equivalent to predicate devices, indicating these modifications did not alter fundamental technological characteristics negatively. |
  | Mode of Operation: Substantially equivalent to predicate devices. | No changes in the fundamental mode of operation (cryogenic destruction of tissue by applying extreme cold temperatures) reported, maintaining substantial equivalence. |
  | Performance Characteristics: Substantially equivalent to predicate devices. | The device underwent "comprehensive electrical, mechanical and biocompatibility testing." The submission concludes that it "does not raise any new safety and/or effectiveness issues," implying performance characteristics are consistent with the predicate devices. Specific quantitative performance metrics (e.g., cooling rates, ice ball dimensions, mechanical strength) are not provided in this summary. |
  | Intended Use: Identical to predicate devices, for cryogenic destruction of tissue across specified medical fields. | The intended use statement for the modified SeedNet Family is identical to the original SeedNet System, covering general surgery, dermatology, neurology, thoracic surgery, ENT, gynecology, oncology, proctology, and urology, with specific indications including ablation of prostate and kidney tissue, liver metastases, tumors, skin lesions, and warts. |
  | Safety: No new safety issues raised. | Comprehensive electrical, mechanical, and biocompatibility testing conducted. The device was found not to raise any new safety issues. |
  | Effectiveness: No new effectiveness issues raised. | Comprehensive electrical, mechanical, and biocompatibility testing conducted. The device was found not to raise any new effectiveness issues. |

Detailed Study Information:

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

   • The provided text does not specify a sample size for a test set, nor does it describe a study involving patient data (retrospective or prospective) for performance evaluation in the context of substantial equivalence. The "testing process" mentioned refers to design verification, including electrical, mechanical, and biocompatibility tests of the device itself, rather than a clinical performance study using patient data.
   • No country of origin for such data is mentioned.

2. 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):

   • The document does not describe a study that involved establishing ground truth by human experts for a test set of medical images or patient outcomes. The testing reported is for device verification (electrical, mechanical, biocompatibility).

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

   • No adjudication method is mentioned as there is no described study involving expert review or a test set requiring adjudication in the context of clinical performance.

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 MRMC comparative effectiveness study is mentioned. This device is a cryosurgical unit, not an AI-assisted diagnostic tool for image interpretation, so such a study would not be relevant in this context.

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

   • Not applicable. This is a medical device (cryosurgical unit), not a software algorithm or AI. The performance discussed is about the physical device and its components.

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

   • For the device verification mentioned (electrical, mechanical, biocompatibility testing), the "ground truth" would be established by engineering and laboratory standards, specifications, and reference materials. No clinical outcomes data, pathology, or expert consensus on clinical cases are mentioned as part of the evidence for substantial equivalence, beyond the broad claim that the device raises no new safety or effectiveness issues for its intended use.

7. The sample size for the training set:

   • Not applicable. This is a physical medical device, not an AI or software algorithm that undergoes machine learning training.

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

   • Not applicable as there is no training set for an AI algorithm.

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