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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 SURGIMESH®XB - Skirted mesh is intended for use in the reinforcement of tissues during surgical repair.

The SURGIMESH®XB-Skirted is indicated for the reconstruction of hernias and soft tissue deficiencies and for the temporary bridging of fascial defects. The silicone layer minimizes the tissue attachment to the mesh in the case of direct contact with the viscera

The SURGIMESH®XB - Skirted surgical mesh is a non-absorbable, synthetic mesh, made of non-knitted, non-woven fibers of polypropylene, one surface of which is coated with silicone. The use of SURGIMESH®XB - Skirted mesh provides reinforcement of soft tissues. On the opposite side, the silicone layer minimizes tissue attachment to the mesh in case of direct contact with the viscera. The SURGIMESH®XB - Skirted mesh is supplied sterile and is available in anatomic forms in order to meet individual surgeons' needs.

More specifically, the SURGIMESH® XB - Skirted mesh is composed of a layer of non-woven, non-knitted material made from polypropylene (i.e., SURGIMESH®XB), a skirted part made from polypropylene (i.e., SURGIMESH®WN) linked with the first layer by sewing a PVDF thread into the two parts with a layer of silicone (equivalent to SURGIMESH® XB product material).

This document describes the premarket notification 510(k) for the SURGIMESH®XB - Skirted surgical mesh. The provided text outlines the device's characteristics, intended use, and the performance testing conducted to demonstrate substantial equivalence to predicate devices, rather than a study against a specific set of acceptance criteria with human readers or standalone algorithm performance.

Here's an analysis of the available information regarding acceptance criteria and supporting studies, formatted as requested, and noting where information is not present in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not specified. The document states "Preclinical testing was conducted" but does not detail the number of units or samples tested for each criterion.
• Data Provenance: The studies were preclinical testing conducted by Aspide Medical. The location of these tests (e.g., country of origin) is not explicitly stated, but Aspide Medical is based in LA TALAUDIERE (FRANCE). The studies are retrospective as they summarize testing that has already been performed.

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

This information is not applicable to the provided document. The performance data focuses on technical and material characteristics of a surgical mesh, not on expert interpretations of medical images or clinical outcomes that typically require ground truth established by experts.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods are typically used in studies involving human interpretation or clinical outcomes where there might be disagreement in assessments. The reported tests are objective technical validations against established 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

This information is not applicable. This document describes a medical device (surgical mesh), not an AI-powered diagnostic or assistive technology that would involve human readers or AI assistance.

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

This information is not applicable. This document describes a medical device (surgical mesh), not an AI algorithm.

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

The "ground truth" for the performance testing cited are the established international standards (ISO, USP) for biocompatibility, sterility, packaging, and material characterization. The device's performance was compared against these universally recognized technical standards and against the specifications of predicate devices.

8. The Sample Size for the Training Set

This information is not applicable. This document describes a medical device (surgical mesh) testing and substantial equivalence, not the development or training of an AI model that would require a training set.

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

This information is not applicable. As no AI model or training set is mentioned, there is no ground truth for a training set to be established.

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Veritas Collagen Matrix is intended for use as an implant for the surgical repair of soft tissue deficiencies: this includes but is not limited to the following:

Buttressing and reinforcing staple lines during lung resection (e.g., wedge lobectomy, bullectomy, bronchial resection, blebectomy, resection, segmentectorny, pnuemonectorny, pneumoreduction) and other incision and excision of the lung and bronchus.

Reinforcement of the gastric staple line during the bariatric surgical procedures of gastric bypass and gastric banding.

Abdominal and thoracic wall repair, muscle flap reinforcement, rectal prolapse excluding rectocele, reconstruction of the pelvic floor excluding transvaginal organ prolapse repair, and repair of hernias (e.g., diaphragmatic, femoral, incisional. inquinal. lumbar, paracolostomy, scrotal, umbilical).

Veritas Collagen Matrix minimizes tissue attachment to the device in case of direct contact with viscera.

An implantable surgical patch comprised of non-crosslinked bovine pericardium. Veritas® Collagen Matrix undergoes proprietary processing that allows neo-collagen formation and neo-vascularization of the implanted device and permits replacement of the device with host tissue, or remodeling.

The provided text does not contain a table of acceptance criteria or specific performance metrics of the device as would typically be found in a formal study. Instead, it describes a 510(k) Premarket Notification for the Veritas® Collagen Matrix, which asserts substantial equivalence to previously marketed predicate devices.

However, based on the provided text, we can infer some information relevant to the "acceptance criteria" through the lens of a substantial equivalence determination and the single study mentioned.

Here's an attempt to structure the information based on your request, highlighting what is present and what is not:

Acceptance Criteria and Device Performance for Veritas® Collagen Matrix

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified in the provided document. The text only states "An animal study was conducted."
• Data Provenance: The study was an "animal study," implying pre-clinical data (not human clinical data). The location/country of origin is not specified. It is inherently prospective as it was conducted for this specific submission to evaluate the new indication.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• This information is not provided. As an animal study for a pre-market notification, the "ground truth" would likely be established by the researchers/veterinarians involved in the study, but their number and specific qualifications are not detailed.

4. Adjudication Method for the Test Set

• This information is not provided. Given that it's an animal study assessing physical characteristics (tissue attachment), formal adjudication methods like 2+1 or 3+1 are typically not applicable in the same way they would be for image-based diagnostic studies. The evaluation method would be part of the individual study's protocol.

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

• No, a MRMC comparative effectiveness study was not done. The study described is an animal study, not a human clinical trial involving multiple readers. Therefore, there is no effect size of human readers improving with AI assistance vs. without AI.

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

• Not applicable. This document describes a physical medical device (surgical mesh), not an AI algorithm. Therefore, "standalone" performance in the context of an algorithm is not relevant here. The "standalone" performance here would refer to the device's functional characteristics in the animal model.

7. Type of Ground Truth Used

• The ground truth for the animal study (regarding tissue attachment) would be based on direct observation and histopathological analysis (implied) of the animal tissues post-implantation, assessing the degree of attachment. This would fall under direct scientific observation and potentially pathology.

8. Sample Size for the Training Set

• Not applicable/Not provided. This is a physical device, not an AI algorithm, so there is no "training set" in the machine learning sense. The device itself is "trained" through its manufacturing process and design based on prior knowledge and predicate devices.

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

• Not applicable. As above, there is no training set for an AI algorithm. For the development of the device itself (manufacturing, processing), ground truth is established through extensive material science testing, bio-compatibility studies, and prior pre-clinical/clinical data from its own previous iterations and predicate devices, ensuring it meets specified material properties and safety profiles. The specific animal study discussed was for a new indication, not for the fundamental development/training of the device itself.

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