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The Expanse ICE Aspiration System is indicated for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems.

The Expanse ICE Aspiration System is a peripheral thrombectomy system consisting of several components:

• ICE Aspiration Catheter -
• ICE Aspiration Sheath -
• -Vacuum Fitting
• -High Flow Stopcock Connector
• -Y-Connector with Hemostatic Valve
• Hand Actuator Clip -

The ICE Aspiration System is designed for the minimally invasive removal of thrombus from the peripheral vasculature using aspiration. It is a single use, over-the-wire, catheterbased system with the ability to infuse fluid. The ICE Aspiration System consists of one aspiration catheter, one aspiration sheath, one vacuum fitting, one high flow stopcock connector, one Y-connector with hemostatic valve, and a hand actuator clip.

The ICE Aspiration System is introduced to the primary occlusion. The Aspiration Catheter is advanced through the Aspiration Sheath and targets aspiration directly to the thrombus. The Aspiration Catheter is then retracted back into the Aspiration Sheath. This process of extension and retraction of the Aspiration Catheter is then repeated to fully aspirate the clot. Suction is applied directly to the Aspiration Catheter from an external vacuum source to aspirate thrombus from an occluded vessel (maximum pressure -27.6 in Hg and minimum pressure of -8.0 in Hg).

Sterile saline flows through the Aspiration Sheath and into the Aspiration Catheter when connected proximally. No saline is injected into the patient during aspiration. The Aspiration Catheter and Sheath are visible under fluoroscopy. The hand actuator is an optional, proximal clip attached to the Aspiration Catheter to assist the user.

This document is a 510(k) premarket notification for the ICE Aspiration System, a medical device. It's a regulatory submission to the FDA, not a study report demonstrating acceptance criteria with a specific test set, ground truth, or MRMC study for AI assistance.

The document primarily focuses on establishing "substantial equivalence" of the ICE Aspiration System to existing predicate devices (Indigo Aspiration System and JETi 88 Peripheral Thrombectomy System) for regulatory clearance. It does not contain information about a study proving specific performance metrics against an AI-driven acceptance criteria for a diagnostic or AI-assisted device.

Therefore, I cannot provide the requested information from this document because it does not contain the details of an AI-related performance study. The "Performance Data" section (Section 5) refers to "Bench and animal testing" and lists various non-clinical tests (e.g., biocompatibility, fatigue, kink resistance), which are standard for most medical device clearances, but not the type of AI-specific performance study you are asking about.

The document does not describe:

• A table of acceptance criteria and reported device performance in the context of an AI study.
• Sample size, data provenance, or details about test sets for AI evaluation.
• Number of experts, their qualifications, or adjudication methods for establishing ground truth for AI.
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done.
• Standalone AI performance.
• Type of ground truth for AI.
• Training set sample size or how ground truth for training was established for an AI system.

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The ICEfy™ 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 destroy tissue (including prostate and kidney tissue, liver metastases, tumors, and 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. 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, dermatoffbromas, small hemangiomas, multiple warts, plantar warts, actinic and sebortheic 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 CX technology in which a heating element inside the cryoablation needle can be energized to cause thawing.

The provided text is a 510(k) FDA clearance letter and summary for a medical device (ICEfx™ Cryoablation System). It describes the device, its intended use, and how it compares to a predicate device. However, it does not contain the information requested regarding acceptance criteria, sample sizes for testing, expert involvement, or any data from a multi-reader multi-case (MRMC) study or standalone AI performance.

The document states that "A full battery of verification and validation testing was conducted on the ICEfx Cryoablation System to ensure that the design, functionality, and performance met the specified requirements." It lists types of testing like system testing, electrical testing, mechanical testing, software testing, and usability testing, and concludes that "Test results demonstrated that the ICEfx Cryoablation System meets defined specifications..."

However, it does not provide the specific acceptance criteria, nor the quantitative results of these tests. The document emphasizes that the device is "substantially equivalent" to a predicate device by having the "same technology and principle of operation." This suggests that the "tests" were primarily to demonstrate conformity to existing standards and to ensure the new device performed equivalently to the predicate, rather than to establish novel performance metrics or to evaluate against new clinical endpoints in the way an AI/ML device might be assessed with a detailed performance study.

**Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for the test set or data provenance.
3. Number and qualifications of experts for ground truth.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study results or effect size.
6. Standalone performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.**

The document is a regulatory approval, not a detailed scientific study report that would contain such experimental data. The focus is on demonstrating substantial equivalence to a previously cleared device.

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ICE CERAMICS, ICE CERAMICS TISSUE, ICE CERAMICS DENTINE +, ICE CERAMICS DYNAMIC DENTINE, FRESCO ENAMEL, FRESCO GINGIVA, FRESCO, FRESCO DENTINE + and FRESCO DYNAMIC DENTINE are type I ceramics for coating, staining and glazing dental restorations made of final-sintered zirconia. They are conceived for patients who require dental restorations in zirconia, such as single crowns, bridges, inlays, onlays or veneers.
ICE STAINS, ICE STAINS PRETTAU®, ICE STAINS GLAZE FLUO and ICE STAINS 3D are type I ceramics for coating, staining and glazing dental restorations made of final-sintered zirconia. They are conceived for patients who require dental restorations in zirconia, such as single crowns, bridges, inlays, onlays or veneers.

All devices included in this submission are dental glass ceramics. There are different device types from three device groups: ICE Ceramics Group, ICE Stains Group, and Fresco Group. The devices are supplied in form of powders or pastes and are available in different colors and/ or in different quantity sizes. Specific accessories are supplied for mixing or changing viscosity.

The provided text describes a 510(k) premarket notification for dental glass ceramics (ICE Ceramics, ICE Stains, Fresco) and includes non-clinical testing data to establish substantial equivalence to a predicate device. However, it does not describe a study involving human readers or AI assistance, nor does it present acceptance criteria in terms of diagnostic performance metrics like sensitivity, specificity, or AUC.

Therefore, many of the requested items cannot be answered from the provided document. The device in question is a dental material, not an AI-powered diagnostic tool.

Here's what can be extracted and what cannot:

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

The acceptance criteria are presented as performance requirements according to the relevant ISO standards for dental ceramics.

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The ICE COMPRESSION FIRST, DUO, and MOOVE Systems combine cold and compression therapies. They are intended to treat post-surgical and acute injuries to reduce edema, swelling, and pain where cold and compression are indicated. They are intended to be used by or on the order of licensed healthcare professionals in hospital, outpatient clinics, athletic training settings, or home settings.

The ICE COMPRESSION FIRST, DUO, & MOOVE System and its accessories, including the Splints, is designed to treat post-surgical and acute injuries to reduce edema, swelling, and pain when cold and compression are indicated. The ICE COMPRESSION System provides cold and compression therapy using ice and water. The ICE COMPRESSION System is a DC-powered, software-controlled device that delivers compressed air and chilled water from the Control Module through tubing to a Splint that is designed for a specific body part (e.g., shoulder, wrist, knee, leg, hip and ankle, back) to treat pain and swelling from injuries and/or surgical interventions.

Here's a summary 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

The document does not present a formal table of distinct "acceptance criteria" and "reported device performance" for each criterion. Instead, it describes performance characteristics related to safety and effectiveness, and how the subject device compares to predicate devices. The primary "acceptance criterion" demonstrated through testing is achieving a minimum skin temperature within a safe range.

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

• Test Set Sample Size: The document mentions that the measurement of the lowest skin temperature was "conducted with healthy volunteers." It does not specify the exact number of healthy volunteers used for this test.
• Data Provenance: The document does not explicitly state the country of origin where the skin temperature test was performed. The data is prospective, as it describes tests conducted for the submission. Other tests (electrical safety, EMC, software V&V, biocompatibility) are also described as prospective design verification and validation testing.

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

• Number of Experts: Not applicable/not stated. The skin temperature measurement was a direct physical measurement, not dependent on expert interpretation for ground truth.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. Since the key performance test involved direct measurement (skin temperature), an adjudication method in the context of expert review is not relevant.

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

• No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Although clinical studies were not needed to demonstrate substantial equivalence of the ICE COMPRESSION FIRST, DUO, & MOOVE Systems..."

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

• Not applicable. This device is a physical system combining cold and compression therapies, not an AI/algorithm-only device. The software controls pressure, displays battery level, and monitors/adjusts temperature, but its performance is integrated into the system's function, not evaluated as a standalone "algorithm only" product in the sense of AI.

7. The Type of Ground Truth Used

• For skin temperature measurement: The ground truth was established by direct physical measurement using sensors to record temperature on healthy volunteers.
• For other safety and performance aspects (Electrical Safety, EMC, Biocompatibility, Software): Ground truth was established through adherence to recognized international standards and regulatory guidance (e.g., IEC 60601, ISO 10993, FDA software guidance for medical devices).

8. The Sample Size for the Training Set

• Not applicable. This device does not involve AI/machine learning that requires a "training set" in the conventional sense for image analysis or diagnostic algorithms. The software's functionality is based on predefined control logic and algorithms for regulating temperature and pressure, not on learning from a large dataset.

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

• Not applicable. As stated above, there is no "training set" for this type of device.

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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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For the fabrication of metal free single and multiple unit crowns/bridges, inlays, onlays bonded dental restorations.

ICE Zirkon Transluzent Plus is a dental porcelain system composed of zirconia based blocks which utilizes CAD/CAM technology for dental restoration fabrication.

This document is a 510(k) submission for a dental material (ICE Zirkon Transluzent Plus), not an AI device. Therefore, the requested information regarding acceptance criteria and studies for an AI device cannot be extracted from this document. The document describes the equivalence of the new dental material to a predicate device based on material properties and established standards, not an AI algorithm's performance.

However, I can provide the information available about the dental material from the document, interpreted through the lens of device performance for that material:

1. Table of Acceptance Criteria and Reported Device Performance

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

• This document describes testing of a physical dental material, not a software device or an AI model. Therefore, "test set" and "data provenance" as typically understood for AI models are not applicable.
• The testing performed would be on physical samples of the ceramic material. The document does not specify the number of samples used for each test (flexural strength, solubility, etc.).
• Data provenance: Not directly described, but the company is Zirkonzahn, GmbH, located in Gais, Italy. The testing would have been performed by or for the manufacturer. This is a prospective evaluation of a new material.

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 applicable to a physical dental material. "Ground truth" for this device refers to objective material properties measured against established international standards (like ISO 6872:2008), not expert consensus on interpretations of images or data.

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

• Not applicable for a physical material. Material properties are measured according to standardized protocols, not adjudicated by experts in the same way as clinical assessments or model outputs.

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 as this is not an AI device.

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

• Not applicable as this is not an AI device. The "device" itself is the ceramic material. Its performance is inherent in its physical and chemical properties.

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

• For this dental material, the "ground truth" for its performance is based on measurements against established international standards and validated testing methodologies (e.g., ISO 6872:2008 for flexural strength, chemical solubility, radioactivity). It's an objective measurement of a material's properties.

8. The sample size for the training set:

• Not applicable as this is not an AI device. There is no "training set" for physical material properties.

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

• Not applicable as this is not an AI device.

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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, 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.

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The PrimeraDx ICEPlex® C. difficile Assay is for the qualitative detection of the Clostridium difficile toxin B gene (tcdB gene) in nucleic acids purified from unpreserved liquid or soft human stool specimens from patients suspected of having C. difficile infection (CDI).

The ICEPlex C. difficile Assay is intended to be used only on the ICEPlex® System, which integrates PCR-based amplification with capillary electrophoresis (CE) for the detection of amplification products. The assay is intended to aid in the diagnosis of CDI. Results should be considered in conjunction with patient clinical history.

PrimeraDx's ICEPlex C. difficile Assay kit is intended to be used only on the ICEPlex System. The ICEPlex C. difficile Assay kit incorporates several universal features and approaches developed at PrimeraDx for the ICEPlex System. The ICEPlex C. difficile Assay kit includes a PCR enzyme and the appropriate PCR buffer system developed, optimized, verified and validated for ideal performance in multiplex PCR with subsequent capillary electrophoresis. The ICEPlex C. difficile assay kit includes a primer mix for detection of the Clostridium difficile toxin B gene (tcdB gene) in human stool specimen from patients suspected of having C. difficile infection (CDI). The ICEPlex C. difficile assay kit is comprised of a PCR enzyme, primer mix, PCR buffer, calibrators mix, injection buffer, internal control, and a positive control.

The ICEPlex System combines two functional modules: an amplification module - PCR (Polymerase Chain Reaction) thermal cycler - and an analysis module -CE (Capillary Electrophoresis) system with fluorescent detection. Individual fluorescent PCR products from multiplexed PCR reactions are analyzed by CE through direct electrokinetic injection into the separating capillaries. The labeled amplicons are separated by size and the dyes are excited by two lasers within the system.

This document describes the ICEPlex C. difficile Assay Kit and its performance characteristics.

Here is the requested information:

1. Acceptance Criteria and Reported Device Performance

Clinical Performance (Comparison to Toxigenic C. difficile Direct Culture)

Analytical Performance

2. Sample Size and Data Provenance

Test Set (Clinical Study):

• Sample Size: 969 compliant specimens were initially enrolled. 952 (98.2%) yielded reportable results and were included in the statistical analysis.
• Data Provenance: Clinical samples collected from patients suspected of C. difficile infection at three independent clinical sites. The data is prospective, as samples were collected for the investigational study. The country of origin is not explicitly stated but implied to be the US, given the 510(k) submission to the FDA.

Analytical Studies:

• Precision: 144 observations for each of the low positive, moderately positive, negative, and Hi/Low samples.
• Reproducibility: 90 observations for C20-80, moderate positive, low positive, and negative samples (across 3 sites * 5 days * 2 runs/day * 3 replicates). 60 observations for positive and negative controls.
• Limit of Detection (LOD): 20 replicates at each concentration level for two C. difficile strains.
• Analytical Reactivity: 20 additional toxigenic C. difficile strains tested.
• Cross Reactivity: Panel of 5 non-toxigenic C. difficile strains, 14 other Clostridium strains, and 54 other pathogens/intestinal flora.
• Interfering Substances: Multiple replicates for each of 14 interfering substances, tested with both negative and contrived positive samples (two C. difficile strains).
• Contamination: 6 runs, each with 24 high positive and 24 negative samples.

3. Number and Qualifications of Experts for Ground Truth

Clinical Study (Test Set):
The ground truth for the clinical study was established by toxigenic C. difficile direct culture. This is a laboratory-based method. The document does not specify the number of human experts involved in interpreting these cultures or their specific qualifications (e.g., medical microbiologists, lab technologists), as it's a standard laboratory procedure.

Discordant Analysis:
For samples with discordant results between the ICEPlex assay and direct culture, microbiological isolation and PCR targeting of 3 appropriate regions of the toxin B gene (different recognition sites than the ICEPlex assay) with bi-directional DNA sequencing were performed. This "truth standard" is a higher-level molecular characterization, implying expert interpretation of molecular results, but the specific number and qualifications of these experts are not provided.

4. Adjudication Method for the Test Set

The primary comparison for the clinical study was the ICEPlex C. difficile Assay versus toxigenic C. difficile direct culture.

For discordant results:
An adjudication method was used where samples showing disagreement between the ICEPlex assay and toxigenic C. difficile direct culture underwent discordant analysis. This analysis involved "microbiological isolation of and PCR targeting of 3 appropriate regions of the toxin B gene (Different recognition sites than the ones used in the ICEPlex C. difficile assay) with bi-directional DNA sequencing."
The results of this discordant analysis were then used to adjudicate the initial discrepancies. For example, of the 20 samples called positive by ICEPlex but negative by direct culture, 16 were confirmed positive by discordant analysis. Similarly, of the 17 samples called negative by ICEPlex but positive by direct culture, 14 were confirmed positive by discordant analysis. This suggests a multi-method adjudictation approach rather than a human expert consensus panel on the original results.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a diagnostic kit for laboratory use, and the study evaluates the performance of the device itself against a reference method (culture), not the impact of the device on human reader performance or a human-in-the-loop scenario. The "readers" in this context are the laboratory instruments and the analytical interpretation of their output.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone performance study was done. The entire clinical performance section evaluates the performance of the ICEPlex C. difficile Assay (algorithm/device only) against toxigenic C. difficile direct culture. There is no human interpretation component integrated into the listed performance metrics for the ICEPlex assay itself. The results presented (PPA, NPA) directly reflect the algorithm's diagnostic accuracy.

7. Type of Ground Truth Used for the Test Set

The primary ground truth used for the clinical test set was toxigenic C. difficile direct culture.

For discordant samples, an enhanced ground truth was established using an "adjudication" or "truth standard" method that involved:

• Microbiological isolation
• PCR targeting of 3 appropriate regions of the toxin B gene (different from the ICEPlex assay targets)
• Bi-directional DNA sequencing

8. Sample Size for the Training Set

The document does not explicitly state a sample size for a training set. For molecular diagnostic assays like this, the 'training' phase often refers to internal assay development, optimization, and analytical validation. The performance studies detailed (precision, reproducibility, LOD, clinical performance) represent the formal validation/test set. It is common for 510(k) submissions to focus on validation rather than explicitly detailing a distinct "training set" for the algorithm itself, as the assay design (primers, probes, CE interpretation rules) is pre-established during development.

9. How Ground Truth for the Training Set Was Established

As noted above, no explicit training set is detailed. However, during the development and optimization of such assays, ground truth for initial assay design and analytical studies would typically be established using:

• Known characterized C. difficile strains (ATCC strains, clinical isolates) at defined concentrations.
• Spiked samples where known amounts of the target (C. difficile) are added to negative stool matrices.
• Reference laboratory methods (e.g., culture, established PCR methods, sequencing) to confirm the presence or absence of the target.

These methods are evident in the analytical performance studies (e.g., ATCC strains for precision, spiked samples for LOD and inclusivity).

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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)

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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