(243 days)
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.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Function as intended | Performed as intended |
| Substantially equivalent to predicate device (EOS) | The ArtVentive Endoluminal Occlusion System (EOS-X) is substantially equivalent to its predicate device, the ArtVentive Endoluminal Occlusion System (EOS). |
| Maintain original device performance for modified sizes (5, 8, 11mm) | Design modifications made to the EOS-X device in sizes 5mm, 8mm and 11mm delivery catheter/implant and associated guide catheters are also substantially equivalent to the predicate device when used according to its intended use. |
| New 16mm size functions similarly | The larger size 16mm delivery catheter/implant is also similar to the other smaller models of EOS and EOS-X in technological characteristics, mechanism of action, intended use and physical characteristics. |
| MRI compatibility | Testing was repeated for MRI compatibility. (No specific results provided, but implies it met previous standards). |
| Corrosion resistance | Testing was repeated for corrosion. (No specific results provided, but implies it met previous standards). |
| Radial strength | Testing was repeated for radial strength. (No specific results provided, but implies it met previous standards). |
| Dimensional and functional design verification/validation | Testing was repeated for dimensional and functional design verification/validation. (Implies successful completion). |
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.
§ 870.3300 Vascular embolization device.
(a)
Identification. A vascular embolization device is an intravascular implant intended to control hemorrhaging due to aneurysms, certain types of tumors (e.g., nephroma, hepatoma, uterine fibroids), and arteriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in neurovascular applications are also not included in this classification, see § 882.5950 of this chapter.(b)
Classification. Class II (special controls.) The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices.” For availability of this guidance document, see § 870.1(e).