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The Siege Vascular Plug is indicated for arterial embolization in the peripheral vasculature.

The Siege Vascular Plug is intended for therapeutic embolization to reduce or obstruct blood flow.

The subject Siege Vascular Plug ("Device") is a self-expanding braided Nitinol vascular embolization 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 the Delivery Wire. The Device is packaged collapsed within a Loader and attached to a 225 cm Delivery Wire that is provided within a hoop dispenser. The Delivery Wire has a lubricious, hydrophilic coating at its distal end (approximately 26.5cm long). A Tuohy Borst Valve is provided for flushing and maintaining hemostasis: a Torque Device is provided for releasing the Device; a Non-Vented Luer Cap is provided for device preparation.

The subject Siege Vascular Plug has been designed with a material, size, configuration, and shape that allows introduction through recommended 0.021" or 0.027" inner diameter commercial microcatheters for the embolization of arterial blood vessels in the peripheral vasculature. The Siege Vascular Plug Devices are provided in three different outer diameters (4.5 mm, 6.5 mm, 8.5 mm) to treat different artery diameter ranges (1.5 - 2.5 mm, 2.5 - 4 mm, 4 - 6 mm) in the peripheral vasculature.

This document describes the 510(k) premarket notification for the Siege Vascular Plug, a medical device intended for arterial embolization in the peripheral vasculature. The device's manufacturer, Merit Medical Systems, Inc., demonstrated substantial equivalence to a legally marketed predicate device (Siege Vascular Plug [K212817]) through a series of non-clinical performance tests and a GLP animal study.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states that "All test results were comparable to the predicate Siege Vascular Plug and the subject Siege Vascular Plug met the predetermined acceptance criteria." However, specific numerical acceptance criteria and detailed performance results for each test are not explicitly provided in the furnished text. Instead, it lists the types of tests conducted:

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

The document does not explicitly state the sample sizes used for each non-clinical test (e.g., number of plugs tested for tensile strength or fatigue).

For the GLP Animal Study:

• Sample Size: Not specified (only mentions "a porcine model").
• Data Provenance: Prospective (as it's a study explicitly conducted to evaluate the subject device). The "country of origin" is not specified.

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

This information is not applicable and therefore not provided in the document. The acceptance criteria were based on "requirements outlined in guidance's and industry standards," and the performance was evaluated through physical and biological testing, not through expert-established ground truth in the context of diagnostic performance.

4. Adjudication Method for the Test Set:

This information is not applicable and therefore not provided in the document. Adjudication methods are typically used for evaluating human-in-the-loop diagnostic performance, not for the technical and biological performance tests described here.

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

No, an MRMC comparative effectiveness study was not done. The evaluation focused on the physical, mechanical, and biological performance of the device itself, not on human reader performance with or without AI assistance.

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

No, a standalone (algorithm only) performance study was not done. The device is a physical vascular plug, not an AI algorithm.

7. The Type of Ground Truth Used:

The "ground truth" for the non-clinical performance tests was adherence to established industry standards, guidance documents, and pre-defined specifications. For the animal study, the ground truth was the observable acute and chronic safety, performance, and handling within the porcine model, compared to a reference device. This is equivalent to performance against established benchmarks/standards and direct observation of biological safety/effectiveness.

8. The Sample Size for the Training Set:

This information is not applicable. The device is a physical medical device, not an AI/ML algorithm that requires a training set.

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

This information is not applicable, as there is no training set for a physical medical device.

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