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The Siege™ Vascular Plug (“Device”) is a self-expanding braided nitinol vascular occlusion implant that is supplied with components used for implantation. The Device has radiopaque marker bands attached to each end and a screw attachment for connection to a Delivery Wire. The Device is packaged collapsed within a Loader and attached to a 180cm Delivery Wire that is provided within a hoop dispenser. Touhy Borst Valves are provided for flushing and maintaining hemostasis. A Torque Device is provided for releasing the Device.

The Siege™ Vascular Plug has been designed with a material, size, configuration and shape that allows introduction through recommended 0.027" inner diameter commercial microcatheters for the occlusion of blood vessels in the peripheral vasculature. The Siege™ Vascular Plug Devices are provided in four different diameters (3mm, 4mm, 5mm, 6mm) to treat different sized blood vessels in the peripheral vasculature. The Siege™ Vascular Plug is designed to be used under fluoroscopy for delivery and implantation in the peripheral vasculature. The main users of the device are physicians trained in vascular embolization.

AI/ML Overview

This document is a 510(k) summary for the Merit Siege Vascular Plug. It states that clinical testing was not required for the determination of substantial equivalence. Therefore, the information requested regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth, and training set information is not applicable to this submission.

The summary focuses on comparing the subject device to predicate devices (KA Medical Micro Plug Set K182944, Amplatzer® Vascular Plug K031810, Micro Vascular Plug System K123803, and Micro Vascular Plug System K133282) based on technological characteristics and performance testing.

Here's what can be extracted from the provided text regarding acceptance criteria and performance, although it doesn't fit the requested table format precisely due to the lack of quantitative criteria:

Acceptance Criteria and Reported Device Performance (Qualitative)

Since no specific quantitative acceptance criteria are provided in the document beyond meeting "predetermined acceptance criteria" and being "comparable to predicate devices," this table is formed qualitatively based on the tests performed and the general statement of meeting criteria.

Acceptance Criteria Category	Reported Device Performance
Performance Testing
Simulated Use (Loader Flushing, Device Handoff, Device Advancement, Deployment, Apposition, Recapture, Redeployment, Device Release)	Successfully completed, met predetermined acceptance criteria, comparable to predicate devices.
Set Strength	Successfully completed, met predetermined acceptance criteria, comparable to predicate devices.
Delivery Wire Proximal Weld Strength	Successfully completed, met predetermined acceptance criteria, comparable to predicate devices.
Loader Fluid Leakage Under Pressure	Successfully completed, met predetermined acceptance criteria, comparable to predicate devices.
Loader Hub to Loader Tube Peak Tensile Force	Successfully completed, met predetermined acceptance criteria, comparable to predicate devices.
Luer Testing	Successfully completed, met predetermined acceptance criteria, comparable to predicate devices.
Fatigue Testing	Successfully completed, met predetermined acceptance criteria, comparable to predicate devices.
Nickel Leach	Successfully completed, met predetermined acceptance criteria, comparable to predicate devices.
Radial Force	Successfully completed, met predetermined acceptance criteria, comparable to predicate devices.
Migration Resistance	Successfully completed, met predetermined acceptance criteria, comparable to predicate devices.
Nitinol Austenite Finish Temperature	Successfully completed, met predetermined acceptance criteria, comparable to predicate devices.
MRI Testing	Successfully completed, met predetermined acceptance criteria, comparable to predicate devices.
Corrosion Testing	Successfully completed, met predetermined acceptance criteria, comparable to predicate devices.
Size Designation	Successfully completed, met predetermined acceptance criteria, comparable to predicate devices.
Packaging Tests
Visual	Successfully completed, met predetermined acceptance criteria, comparable to predicate devices.
Dye Penetration Testing	Successfully completed, met predetermined acceptance criteria, comparable to predicate devices.
Bubble Leak Test	Successfully completed, met predetermined acceptance criteria, comparable to predicate devices.
Seal Peel Strength	Successfully completed, met predetermined acceptance criteria, comparable to predicate devices.
Burst Test	Successfully completed, met predetermined acceptance criteria, comparable to predicate devices.
Sterilization	Successfully completed, met predetermined acceptance criteria, comparable to predicate devices.
Shelf Life	Successfully completed, met predetermined acceptance criteria, comparable to predicate devices.
Biocompatibility	Successfully completed, met predetermined acceptance criteria, comparable to predicate devices.
GLP Animal Study	Successfully completed, met predetermined acceptance criteria, comparable to predicate devices (covering Acute performance, Chronic performance, Tissue response).

The document explicitly states that clinical testing was not required for the determination of substantial equivalence (page 10). Therefore, the following requested information is not applicable in this context:

Sample size used for the test set and the data provenance: Not applicable as no clinical test set was used. "A battery of testing was conducted, on the subject Merit Siege™ Vascular Plug, in accordance with protocols based on requirements outlined in guidance's and Performance industry standards." These tests were likely in vitro or in vivo (animal study).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as there was no clinical test set requiring expert ground truth.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable as there was no clinical test set requiring adjudication.
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 device is a vascular plug, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a vascular plug, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the non-clinical tests, the "ground truth" would be the engineering specifications, industry standards, and biological responses observed in biocompatibility and animal studies, rather than a clinical ground truth. For the animal study, outcomes such as acute performance, chronic performance, and tissue response were evaluated.
The sample size for the training set: Not applicable as no machine learning algorithm was involved.
How the ground truth for the training set was established: Not applicable as no training set for a machine learning algorithm was involved.

In summary, this 510(k) submission for the Merit Siege Vascular Plug demonstrates substantial equivalence through non-clinical testing (performance, biocompatibility, sterilization, and animal studies) rather than clinical studies requiring human data, expert review, or AI performance metrics.

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