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

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.

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.

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:

2. 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).
3. 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.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable as there was no clinical test set requiring adjudication.
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. This device is a vascular plug, not an AI-assisted diagnostic tool.
6. 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.
7. 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.
8. The sample size for the training set: Not applicable as no machine learning algorithm was involved.
9. 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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The Medusa™ Vascular Plug is intended for arterial and venous embolizations in the peripheral vasculature. The product is intended for use by physicians trained and experienced in embolization techniques. Standard techniques for placement of vascular access sheaths, angiographic catheters, and guide wires should be employed.

The Medusa™ Vascular Plug is a coil-based occlusion device intended for embolization procedures in the peripheral vasculature. The Medusa™ Vascular Plug consists of an implant and a delivery system. The implant is constructed of multiple polymer coils that are pre-loaded on to the delivery system. The Medusa™ Vascular Plug coils are delivered concurrently for vascular occlusion in a single application. Like predicate embolic coils, vascular occlusion with the Medusa™ Vascular Plug is achieved by mechanical flow restriction resulting from coil pack delivery that leads to thrombus formation and rapid cessation of blood flow.

This document describes the premarket notification (510(k)) for the Medusa™ Vascular Plug, focusing on its substantial equivalence to predicate devices. The review is based on non-clinical and animal testing.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The study was an in-vivo animal validation study conducted in an ovine (sheep) model. The sample size for this animal study is not explicitly stated in the provided text.

The data provenance is prospective animal study data.

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

The document mentions "occlusion assessed by the physician" during the angiographic assessment. This implies clinical assessment was part of the ground truth determination. However, the number of physicians/experts and their specific qualifications are not explicitly stated.

4. Adjudication Method for the Test Set

The adjudication method for the angiographic assessment and subsequent histopathology is not explicitly detailed. It mentions "occlusion assessed by the physician," but whether this involved multiple physicians, consensus, or a specific rule (e.g., 2+1) is not provided.

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 performed. This study focused on an animal model, not human readers assessing cases.

6. 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 AI algorithm. Therefore, the concept of "standalone (algorithm only without human-in-the-loop performance)" does not apply. The performance evaluated here is the physical device's occlusive capabilities.

7. The Type of Ground Truth Used

The ground truth was established through a combination of:

• Angiographic assessment (visual assessment of occlusion by a physician).
• Gross necropsy (post-mortem examination of the animal).
• Microscopic examination.
• Histopathology (microscopic examination of tissues for disease or abnormalities).

This provides a multi-faceted biological and anatomical ground truth from the animal model.

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical device (vascular plug), not an AI algorithm that requires a training set. The "testing" in this context refers to performance validation of the physical device.

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

Not applicable, as there is no training set for a physical device like a vascular plug. The "ground truth" (or established performance criteria) for the device's function was derived from the performance of the predicate devices.

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The AMPLATZER® Vascular Plug II is indicated for arterial and venous embolizations in the peripheral vasculature.

The AMPLATZER® Vascular Plug II is a sterile, single-use, triple-lobed. self-expanding Nitinol mesh occlusion device, with a screwattachment for a Delivery Wire and radiopaque marker bands at both ends. The Plug is attached to a 135 cm Delivery Wire with a stainless steel screw. The AMPLATZER® Vascular Plug II is provided contained within a Loader Device that facilitates loading into a delivery catheter. The Delivery Wire is coiled and packaged in a hoop dispenser.

The AMPLATZER® Vascular Pluq II is available in fully-expanded diameters of: 4mm, 6mm, 10mm, 12mm, 14mm and 16 mm.

The provided 510(k) summary for the AMPLATZER® Vascular Plug II does not contain the level of detail regarding acceptance criteria and performance studies typically associated with AI/ML device submissions. This document describes a medical device, an embolization plug, which is a physical device, not a software algorithm. Therefore, many of the requested categories related to software performance, AI/ML models, and clinical study design (like ground truth, expert consensus, MRMC studies, large training/test sets, etc.) are not applicable or detailed in this type of submission for a physical device.

However, I will extract and synthesize the relevant information presented in the document to address as many of your points as possible, adapting the interpretation to fit the context of a physical medical device.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" in the format typically seen with software performance metrics (e.g., sensitivity > X%, specificity > Y%). Instead, the "acceptance criteria" for this physical device are implicitly tied to demonstrating "substantial equivalence" to the predicate device through various verification and validation tests. The "reported device performance" refers to the successful completion of these tests, confirming functional equivalence.

• Handoff and advancement forces: Confirmed functional equivalence.
• Device deployment: Confirmed functional equivalence.
• Recapture and detachment verification: Confirmed functional equivalence.
• Overall strength determinations: Confirmed functional equivalence. |
  | Validation of product under simulated conditions of use | - Animal testing: Validated the product under simulated conditions of use. |
  | Maintain identical intended uses as predicate device | - The AMPLATZER® Vascular Plug II is indicated for arterial and venous embolizations in the peripheral vasculature, identical to the predicate device. |
  | Maintain same patient-contacting materials | - The AMPLATZER® Vascular Plug II has exactly the same patient-contacting materials as the predicate. |
  | Maintain same Nitinol Delivery Wire | - The AMPLATZER® Vascular Plug II has the same Nitinol Delivery Wire as the predicate. |
  | Maintain same operating principle | - Both devices operate on the principle of a self-expanding Nitinol mesh delivered through a catheter, expanding to occlude the vessel upon release. |
  | Device modifications (shape, braid layers, loader material) do not adversely affect performance and substantial equivalence. | - Verification and validation testing (radial force, deployment, etc.) confirms the functional characteristics are substantially equivalent despite these modifications. |

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

• Sample Size for Test Set: The document does not specify a numerical sample size for the "test set" in terms of cases or patients. The testing described (radial force, handoff, deployment, etc.) likely involved a number of device units or components, and animal testing would have involved a certain number of animals. However, these specific numbers are not provided.
• Data Provenance:
  • Country of Origin: Not specified. Standard practice for such tests often involves in-house labs or contract research organizations, but the geographical location is not mentioned.
  • Retrospective or Prospective: The testing described (radial force, deployment, animal testing) is inherently prospective. These are laboratory and in-vivo tests conducted specifically for the purpose of demonstrating device performance and safety for the 510(k) submission. They are not analyses of pre-existing clinical data.

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

This concept is not applicable to this type of device submission. "Ground truth" established by experts (e.g., radiologists interpreting images) is a concept relevant to AI/ML or diagnostic devices where human interpretation is being benchmarked or assisted. For a physical embolization device, the "ground truth" is determined by direct physical measurements (e.g., radial force, deployment success) and direct observation of physiological effects in animal models. No human experts are described as establishing a "ground truth" in the diagnostic sense for these tests.

4. Adjudication Method for the Test Set

This is not applicable in the context of this device and testing. Adjudication methods like 2+1 or 3+1 are used to resolve discrepancies in human interpretations or expert opinions when establishing ground truth for diagnostic accuracy studies. For physical device performance tests (e.g., radial force, deployment), results are typically objective measurements or observations, rather than subjective interpretations requiring adjudication.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

• Done?: No, an MRMC comparative effectiveness study was not done or reported.
• Effect Size of Human Readers Improve with AI vs. Without AI Assistance: This question is not applicable. An MRMC study with AI assistance is specifically designed for AI/ML diagnostic or assistive devices to measure the impact of AI on human reader performance. The AMPLATZER® Vascular Plug II is a therapeutic embolization device, not an AI-powered diagnostic tool.

6. Standalone (i.e., algorithm only without human-in-the loop performance) Study

This is not applicable. The AMPLATZER® Vascular Plug II is a physical embolization device, not an algorithm. Therefore, there is no "standalone algorithm" performance to report.

7. Type of Ground Truth Used

The "ground truth" for this device's performance evaluation was based on:

• Engineering and Biomechanical Measurements: Objective measurements of physical properties (e.g., radial force, handoff force, deployment success, recapture, detachment, strength).
• In Vivo Observation: Direct observation of the device's performance and physiological interaction in animal models under simulated conditions of use. Essentially, the "truth" was whether the device performed as expected and intended in a controlled physical/biological environment.

8. Sample Size for the Training Set

This is not applicable. The concept of a "training set" refers to data used to train an AI/ML model. This device is a physical product, not an AI/ML system.

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

This is not applicable for the same reasons as point 8.

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