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The ArtVentive Endoluminal Occlusion System - EOS-X is indicated for arterial and venous embolization in the peripheral vasculature.

The ArtVentive Endoluminal Occlusion System (EOS-X) has been developed for arterial and venous embolization in the peripheral vasculature. The system consists of three major components: a preloaded implant, the delivery catheter, and the guide catheter with dilator. The EOS-X is intended for single use only.

Like the predicate ArtVentive Endoluminal Occlusion System (EOS)™, the ArtVentive Endoluminal Occlusion System (EOS-X) is comprised of an implant made of a Nitinol coil scaffold with an ePTFE occlusion membrane and is designed with radial force sufficient to provide stiffness and strength against the vessel wall and minimize post-deployment migration. The delivery system is made up of a delivery catheter and the guide catheter with dilator. The implant delivery catheter contains one implant loaded on the distal end and a deployment handle on the proximal end connected by the shaft. The delivery catheter has a low profile and is flexible to allow for trackability and pushability. The implant itself and the catheter's distal end are visible under fluoroscopy.

The guide catheter is a braided shaft with a stiff proximal section and a more flexible distal section to enable tracking through tortuous peripheral vasculature. A radiopaque marker on the distal end of the catheter is visible under fluoroscopy. The guide catheter is tapered to fit over the dilator. The dilator fits inside the guide catheter exiting out through the distal end. The dilator also has a tapered end for ease of advancement into the blood vessel. The guidewire and dilator are removed from the guide catheter once it is in position for delivery of the implant.

The provided text describes the ArtVentive Endoluminal Occlusion System (EOS-X), a vascular embolization device, and its substantial equivalence to a predicate device (ArtVentive Endoluminal Occlusion System, EOS). However, the document does not contain acceptance criteria for device performance, nor details of a study proving the device meets specific performance criteria in the way requested (e.g., using metrics like sensitivity, specificity, or accuracy compared to a ground truth).

Instead, the document focuses on demonstrating substantial equivalence to a previously cleared device (ArtVentive Endoluminal Occlusion System, EOS). This is a common regulatory pathway for medical devices in the US, where a new device can be cleared if it is shown to be as safe and effective as a legally marketed predicate device.

The "study" referenced in this document is primarily a series of engineering performance studies and design verification/validation testing. This testing is to ensure the new device, particularly the new 16mm size and minor design modifications to existing sizes, performs as intended and is comparable to the predicate.

Here's an attempt to answer your questions based on the provided text, while acknowledging the absence of some requested information:

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

The document does not explicitly state acceptance criteria in terms of performance metrics (like accuracy, sensitivity, or specificity) or numerical thresholds for clinical outcomes. The "reported device performance" is described as performing "as intended" and being "substantially equivalent" to the predicate.

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

The document explicitly states "Engineering Performance Studies" and "design verification/validation testing." These are typically bench and pre-clinical tests, not clinical studies with human patient data. Therefore, concepts like country of origin for patient data or retrospective/prospective designations are not applicable. The sample sizes for these engineering tests are not specified in the provided text.

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

This type of information is generally relevant for clinical studies where expert consensus or diagnostic accuracy is being assessed. Given that the document refers to engineering and design verification/validation tests, there is no mention of external experts establishing a "ground truth" for a test set in the conventional clinical sense. The ground truth for engineering tests would be defined by established manufacturing specifications, industry standards, and the performance characteristics of the predicate device.

4. Adjudication method for the test set

Not applicable, as this is typically used in clinical studies involving human interpretation or subjective measurements. The engineering tests would likely have objective pass/fail criteria.

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. The device described is a physical vascular embolization system, not an AI-assisted diagnostic tool.

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

Not applicable. As above, this is a physical medical device, not an algorithm.

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

For the engineering performance studies and design verification/validation, the "ground truth" would be defined by:

• Design specifications and requirements: The device's components and overall system must meet predetermined engineering and material specifications.
• Performance of the predicate device: The EOS-X is compared to the established performance of its predicate, EOS.
• Industry standards and regulatory guidelines: The device must conform to relevant standards for medical devices of its type.

8. The sample size for the training set

Not applicable, as this is not an AI/machine learning algorithm.

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

Not applicable.

In summary, the provided document details the regulatory clearance of a medical device (ArtVentive Endoluminal Occlusion System, EOS-X) via the 510(k) pathway, which relies on demonstrating substantial equivalence to a predicate device. The "studies" referenced are engineering performance tests and design verification/validation to ensure the new device, including a new size and minor modifications, performs comparably to the predicate. It does not contain information about clinical trials, acceptance criteria based on clinical performance metrics, or the involvement of human experts in establishing ground truth for a test set in the context of diagnostic accuracy.

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The ArtVentive Endoluminal Occlusion System (EOS) is intended for arterial and venous embolization in the peripheral vasculature.

The ArtVentive Medical Group Endoluminal Occlusion System™ (AVMG EOS™) has been developed for arterial and venous embolizations in the peripheral vasculature. The system consists of three major components: a preloaded implant, the delivery catheter, and the guide catheter with dilator. The AVMG EOS™ is intended for single use only.

Like the parent ArtVentive Endoluminal Occlusion System - EOS, the proposed 11mm size of the device is comprised of an implant made of a Nitinol coil scaffold with an ePTFE occlusion membrane and is designed with radial force sufficient to provide stiffness and strength against the vessel wall and minimize post-deployment migration. The delivery system is made up of a delivery catheter and the guide catheter with dilator. The implant delivery catheter contains one implant loaded on the distal end and a deployment handle on the proximal end connected by the shaft. The delivery catheter has a low profile and is flexible to allow for trackability. The implant itself and the catheter's distal end are visible under fluoroscopy.

The guide catheter is a braided shaft with a stiff proximal section and a more flexible distal section to enable tracking through tortuous peripheral vasculature. A radiopaque marker on the distal end of the catheter is visible under fluoroscopy. The tip of the guide catheter is tapered to fit over the dilator. The dilator fits inside the guide catheter exiting out through the distal end. The dilator also has a tapered end for ease of advancement into the blood vessel. The guidewire and dilator are removed from the guide catheter once it is in position for delivery of the implant.

This document is a 510(k) Pre-Market Notification from the FDA regarding the ArtVentive Medical Group's Endoluminal Occlusion System (EOS). It primarily establishes substantial equivalence to a predicate device rather than detailing a clinical study with acceptance criteria in the typical sense of a diagnostic or accuracy study.

However, based on the provided text, we can piece together what functioned as "acceptance criteria" through performance data and a comparison to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The design verification and validation testing was repeated as necessary for the minor design modifications to the cleared 5mm and 8mm delivery catheter/implant and the 6 Fr guide catheter. |
| Material Equivalence: Nitinol coil with an ePTFE polymeric cover | The device uses a Nitinol coil with an ePTFE polymeric cover, which is the same as the predicate device. |
| Design Features Equivalence: Flexibility, low profile, immediate/acute occlusion, ePTFE cover, retrievability, two-stage deployment handle, stiff proximal/flexible distal catheter sections, side port for flushing/pre-expansion. | The device is described with flexible, low profile for immediate, acute occlusion, incorporates an ePTFE cover, is retrievable, has a two-stage deployment handle, a stiff proximal section for pushability and a flexible distal section for trackability, and a side port to accommodate syringe attachment to flush and pre-expand the ePTFE membrane. These features are directly compared and found to be the same as the predicate device. |
| Mechanical Detachment Method Equivalence: Mechanical in nature | The detachment mechanism is mechanical in nature, same as the predicate device. |
| Treatment Method Equivalence: Permanent Implant | The treatment method is described as a permanent implant, same as the predicate device. |
| Application Method Equivalence: Via delivery catheter through guide catheter to target vessel | The device is applied via a delivery catheter through a guide catheter to the target vessel, same as the predicate device. |

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

The document explicitly states "Bench studies" and "design verification and validation testing." This indicates in-vitro or laboratory testing rather than testing on human or animal subjects. Therefore, human test set sample size and provenance information is not applicable. The data provenance would be from internal laboratory testing.

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

This section is not applicable as the document describes bench testing and design verification/validation, not a study requiring expert clinical assessment for ground truth. The "ground truth" here would be defined by engineering specifications and predicate device performance characteristics.

4. Adjudication method for the test set

This is not applicable as the document describes bench testing and design verification/validation, not a study requiring adjudication of expert opinions.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document describes bench studies and design verification/validation directly comparing the device characteristics to a predicate, not a study involving human readers' performance.

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

This refers to a device, not an algorithm. Therefore, an algorithm-only standalone performance study is not applicable. The device's performance was evaluated in bench studies (standalone performance relative to engineering specifications and predicate device).

7. The type of ground truth used

The ground truth used for this submission is implicitly based on:

• Engineering specifications and design requirements: The device's physical dimensions, material properties, and functional capabilities (e.g., radial strength, trackability) were measured and compared against established requirements.
• Predicate device characteristics: The device was compared feature-by-feature (technological characteristics, mechanism of action, intended use, physical characteristics, materials, detachment method, application method) to a legally marketed predicate device (K133924 ArtVentive Medical Group, Inc./EOS).
• Performance "as intended": Demonstrating that the device performs according to its designed function in bench tests.

8. The sample size for the training set

This document describes a 510(k) submission focused on proving substantial equivalence based on bench testing and design verification. It details the device's characteristics and compares them to a predicate. There is no mention of a "training set" in the context of machine learning or AI, as this is a medical device approval based on physical and functional characteristics.

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

As there is no mention of a "training set", this question is not applicable.

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The ArtVentive Medical Group Endoluminal Occlusion System (AVMG EOS) is indicated for the percutaneous occlusion of the peripheral arterial and venous vasculature.

The ArtVentive Medical Group Endoluminal Occlusion System™ (AVMG EOS™) has been developed for arterial and venous embolizations in the peripheral vasculature. The system consists of three major components: a preloaded implant, the implant carrier catheter, and the guide sheath with removable core. The AVMG EOS™ is intended for single use only.

The implant is made of a Nitinol coil scaffold with an ePTFE occlusion membrane and is designed with radial force sufficient to provide stiffness and strength against the vessel wall and minimize post-deployment migration. The delivery system is made up of the implant carrier catheter and the guide sheath with removable core. The implant carrier catheter contains one implant loaded on the distal end and a deployment handle on the proximal end connected by the shaft. The delivery catheter has a low profile and is flexible to allow for trackability and pushability. The implant itself and catheter's distal end are visible under fluoroscopy.

The guide sheath is a braided shaft with a stiff proximal section and a more flexible distal section to enable tracking through tortuous peripheral vasculature. A radiopaque marker on the sheath is visible under fluoroscopy. The tip of the sheath is tapered to fit over the removable core. The removable core fits inside the guide sheath, exiting out through the distal end. The removable core also has a tapered end for ease of advancement into the blood vessel. The guidewire and core are removed from the guide sheath once it is in position for delivery of the implant.

This document, a 510(k) summary for the ArtVentive Medical Group Endoluminal Occlusion System (EOS)™, describes the device's technical characteristics, intended use, and a comparison to predicate devices, along with performance data to demonstrate substantial equivalence.

Here's an analysis to extract the requested information:

1. Table of Acceptance Criteria and the Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a quantitative format for specific clinical performance metrics like success rates or complication rates, which are typical for medical device studies that involve human subjects for clinical efficacy. Instead, it focuses on demonstrating substantial equivalence through various bench and animal testing. The "reported device performance" refers to the successful completion and outcomes of these tests.

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

• Sample Size for Test Set: The document explicitly mentions "GLP chronic animal safety testing." For such tests, a sample size would typically involve a specific number of animals. However, the exact number is not specified in this document.
• Data Provenance: The animal studies were "GLP chronic animal safety testing," implying a controlled laboratory environment. The country of origin is not specified, but given the FDA filing, it's typically either conducted in the US or in facilities compliant with US GLP standards. The study is prospective in nature, as it involves pre-clinical testing of the device for safety.

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

• Number of Experts: This information is not provided in the document.
• Qualifications of Experts: This information is not provided in the document. For animal studies, ground truth establishment would typically involve veterinary pathologists, toxicologists, and other animal care specialists, but their specific involvement or qualifications are not detailed here.

4. Adjudication Method for the Test Set:

• The document describes "GLP chronic animal safety testing," which adheres to Good Laboratory Practice regulations. Adjudication in such studies typically involves independent pathology reviews and data audits. However, the specific adjudication method (e.g., 2+1, 3+1) is not explicitly stated.

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

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human readers interpreting images, not for an embolization system like the AVMG EOS™, which is a therapeutic device.
• Effect Size of Human Readers Improvement with AI: Not applicable.

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

• No, a standalone algorithm performance study was not done. This device is a physical medical implant, not an AI algorithm.

7. The Type of Ground Truth Used:

• For the animal safety testing, the ground truth would be based on histopathology, clinical observations, and potentially laboratory assays from the animal subjects, evaluated by veterinary pathologists and researchers. This is a form of pathology and observational outcomes data.
• For the other bench tests (dimensional, sterilization, etc.), the ground truth is established by engineering specifications, standardized test methods, and quantitative measurements.

8. The Sample Size for the Training Set:

• Not applicable. This device is a physical medical implant, not an AI/ML algorithm that requires a "training set" in the computational sense. The manufacturing process and quality control would involve testing individual batches of devices and components, but this is distinct from training an algorithm.

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

• Not applicable. As a physical device, there is no "training set" in the context of machine learning. The "ground truth" for its design and manufacturing would be established by engineering specifications, material standards, and validated manufacturing processes.

Summary of Device Performance Study:

The primary study mentioned is GLP chronic animal safety testing, alongside various bench studies (dimensional verification, sterilization, transit/package integrity, MRI compatibility, corrosion, radial strength, and biocompatibility). These studies collectively aim to demonstrate the safety and functional performance of the ArtVentive Medical Group Endoluminal Occlusion System (AVMG EOS™), thereby proving its substantial equivalence to existing predicate devices (AGA Medical/Amplatzer® Vascular Plug II, AGA Medical/Amplatzer® Vascular Plug 4, and Reverse Medical MVP™ Micro Vascular Plug System). The document emphasizes that these tests indicate the device performs as intended and that differences between it and the predicates do not raise any significant safety or effectiveness issues.

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