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The AZUR Vascular Plug is indicated for use to reduce or block the rate of blood flow in arteries of the peripheral vasculature.

The AZUR Vascular Plug consists of an AZUR vascular occlusion plug implant that is attached to a delivery wire which is intended to be delivered to the treatment site through a microcatheter.

The AZUR Vascular Plug implant is an embolization device consisting of a conformable, self-expanding nitinol braided wire frame surrounding a flexible, occlusive membrane. The implant comes in three sizes, small (5 mm), medium (8 mm) and large (10 mm). The implant is deployed in an appropriately sized vessel to reduce or block the flow of blood. The implant has radiopaque markers to provide visual confirmation of deployment location during the interventional treatment. The implant is delivered through a microcatheter on a detachable delivery system.

The delivery wire attached to the AZUR Vascular Plug implant is 185cm in length and an outer diameter suitable for delivery through a 0.027" ID microcatheter.

A detachment controller powers the delivery pusher to detach the implant. The microcatheter and the detachment controller are provided separately.

The provided text is a 510(k) premarket notification for a medical device called the AZUR Vascular Plug. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving efficacy through clinical trials with strict acceptance criteria and performance data in the way a new drug or a novel AI diagnostic device might.

Therefore, the typical structure for detailing "acceptance criteria and the study that proves the device meets the acceptance criteria" as requested, particularly regarding "device performance" in terms of accuracy, sensitivity, or specificity, and the involvement of "experts" for "ground truth," "MRMC studies," or "standalone performance" metrics, does not directly apply to this document. This document is about device safety and technological equivalence, not clinical performance analysis of an AI model or diagnostic tool.

However, I can extract and infer information from the provided document to answer as many of the requested points as possible, focusing on what constitutes "acceptance criteria" and "proof" within the context of a 510(k) submission for a vascular plug.

Here's how to interpret the request in the context of the provided document:

• "Acceptance criteria" and "reported device performance": For a vascular plug, these relate to its physical and functional characteristics (e.g., ability to obstruct blood flow, detach reliably, biocompatibility, mechanical integrity). The "proof" comes from an array of non-clinical (bench and animal) tests, not typically from human clinical outcomes data as you'd see for an AI diagnostic.
• "Ground truth": This is established by the design specifications and the results of the physical and chemical tests, rather than expert labels on medical images.
• "Multi-reader multi-case (MRMC) comparative effectiveness study": This is not applicable to a physical device like a vascular plug. This type of study is for evaluating the impact of a diagnostic tool (often AI-assisted) on human reader performance.
• "Standalone (i.e., algorithm only without human-in-the-loop performance)": Again, not applicable as this is not an algorithm or AI device.
• "Training set": Not applicable as there is no AI model being trained.

Based on the provided K191680 document for the AZUR Vascular Plug, here is an interpretation of the requested information:

This 510(k) submission demonstrates substantial equivalence to a predicate device, the Medtronic Micro Vascular Plug (K150108), rather than proving clinical efficacy or diagnostic performance through human studies with strict acceptance criteria. The "acceptance criteria" and "performance" are framed in terms of the device's physical, chemical, and mechanical properties, and its ability to function as intended in non-clinical settings.

1. Table of Acceptance Criteria and Reported Device Performance

For a physical device like a vascular plug, "acceptance criteria" are the predefined specifications and thresholds for its physical, mechanical, and biocompatibility properties, and "reported device performance" refers to the results of the tests conducted to demonstrate that these criteria are met.

• Visual/Dimensional Inspection
• Electrical Resistance
• Exhaustive Extraction Study
• Simulated Use (Preparation/Flush, Introduction, Tracking, Advancement, Kink Resistance, Flexibility, Catheter Compatibility, Deployment, Retraction, Detachment, Wall Apposition)
• Migration Resistance
• Overall performance
• Radial force
• Attachment strength
• Implant joint Tensile Strength
• Pusher Sleeve Retention
• Particulate
• Nickel Ion Release
• Corrosion
• Magnetic Resonance (MR) Testing
• Radiopacity
• Occlusion Time
• Shelf Life |
  | Safety & Effectiveness (In-vivo) | Device must perform safely and effectively in a living system. | Evaluated in "a number of animal studies including multiple animal species and implantation sites," specifically:
• Porcine large animal study
• Intramuscular implant rabbit study
  Conclusion: "The nonclinical data support the substantial equivalence of the subject device and the verification and validation testing demonstrate that the subject device should perform as intended when used as instructed in the instructions for use." |
  | Sterility | Device must be sterile for use. | Same as predicate: EtO (Ethylene Oxide) sterilization process. "No difference. Identical sterilization process." |
  | Radiopacity | Device must be visible under fluoroscopy. | Platinum marker bands at each end of the plug. "Identical marker bands" to predicate. |
  | Delivery System Compatibility | Device must be deliverable through specified microcatheters. | Designed for delivery through a 0.027" ID microcatheter. This is a design difference from the predicate (0.027" to 0.043" ID) but deemed acceptable due to bench and animal testing. |
  | Detachment Mechanism Reliability | The plug must detach reliably. | Thermoelectric detachment system. This is a design difference from the predicate (Mechanical Detachment) but considered acceptable based on "results of bench testing and physician usability study." |

2. Sample Size for the Test Set and Data Provenance

• Sample Size for Test Set: Not specified in terms of number of plugs or specific quantities for each test. The document states "a number of animal studies" and lists "Porcine large animal study" and "Intramuscular implant rabbit study." For bench testing, it lists types of tests but not the quantity of devices tested.
• Data Provenance: The studies were internal to MicroVention Inc. and likely conducted at contracted labs. The document does not specify a country of origin for the data or whether the studies were retrospective or prospective, but these would inherently be prospective non-clinical (bench and animal) studies for regulatory submission purposes.

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

• Not Applicable in the traditional sense. For a physical device, "ground truth" is established by the design specifications, material properties, and objective measurements from bench and animal studies. There isn't a need for multiple human experts to establish "ground truth" through interpretation (e.g., reading images).
• However, the document mentions a "physician usability study" in relation to the detachment system. While not an "expert ground truth" for performance metrics like sensitivity/specificity, it implies the involvement of physicians in evaluating a functional aspect of the device. The number and qualifications of these physicians are not specified.

4. Adjudication Method for the Test Set

• Not Applicable. Adjudication methods (e.g., 2+1, 3+1) are used to resolve discrepancies in human expert interpretations, typically in diagnostic imaging studies. This is not relevant to the evaluation of a physical medical device like a vascular plug based on bench and animal testing.

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

• No, not done. This type of study is specifically designed for evaluating diagnostic tools (often AI-assisted systems) and their impact on human reader performance. It is not applicable to a physical vascular plug.

6. Standalone (Algorithm Only) Performance Study

• No, not done. This concept is only relevant for AI algorithms or diagnostic software. The AZUR Vascular Plug is a physical medical device.

7. Type of Ground Truth Used

• For Biocompatibility: Established by adherence to ISO 10993 standards and direct laboratory measurements of biological responses to materials.
• For Mechanical/Functional Performance: Established by engineering specifications, direct physical measurements (e.g., tensile strength, radial force), and observation of functional success/failure in controlled bench and simulated use environments.
• For In-Vivo Performance: Established by histological analysis, physiological observations, and procedural success/failure in animal models as per pre-defined animal study protocols.

In essence, the "ground truth" is derived from rigorous, objective, and reproducible scientific and engineering test results against pre-defined specifications.

8. Sample Size for the Training Set

• Not Applicable. This is a physical device, not an AI model requiring a training set.

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

• Not Applicable. As there is no training set, there is no ground truth to establish for one.

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