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

The AMPLATZER Vascular Plug is provided sterile and is intended for one-time use. The AMPLATZER Vascular Plug is a self-expandable, cylindrical device made from a Nitinol wire mesh. The device is secured on both ends with platinum marker bands. The delivery system is comprised of a 135 cm long, stainless steel delivery cable and a PTFE loader. The AMPLATZER Vascular Plug is preloaded in a loader and delivered through currently available standard 5 or 6 French guiding catheters.

Here's an analysis of the provided text regarding acceptance criteria and the supporting study for the AMPLATZER® Vascular Plug:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes various tests performed on the AMPLATZER Vascular Plug and its delivery system, primarily focusing on mechanical performance, biocompatibility, and comparing its embolization efficacy to existing coil devices in an animal model. Unlike typical AI/software device submissions, this document focuses on a physical medical device. Therefore, the "acceptance criteria" are more about demonstrating safety and functional equivalence to predicate devices, rather than specific performance metrics like sensitivity, specificity, or AUC as seen in AI/ML applications.

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

• Test Set (Animal Study): The document refers to "canines" and "18 vessels" for the 2-month recanalization data, implying a relatively small sample size, likely involving a single study. However, the exact number of animals or vessels used for the initial occlusion time and positioning precision comparisons is not explicitly stated, only "coils" and "plugs" groups.
• Data Provenance: The study was an animal study, specifically using canines. No geographical provenance for the animals is provided. It appears to be a prospective study undertaken specifically for device evaluation.

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

This type of information is generally not applicable to a physical device's animal and bench testing. The "ground truth" in this context is the direct physical observation of device performance (e.g., occlusion time, migration, recanalization, mechanical strength, biocompatibility reactions). These assessments are typically performed by trained research staff, veterinarians, and laboratory technicians, not clinical "experts" in the sense of radiologists interpreting images or pathologists reviewing slides.

4. Adjudication Method for the Test Set:

Not applicable in the typical sense of clinical adjudication or expert consensus for image interpretation. The measurements (e.g., occlusion time) and observations (e.g., migration, endothelialization) are direct and objective, or based on standard laboratory protocols and analyses.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This submission is for a physical medical device (embolization plug), not an AI-powered diagnostic or assistive tool. Therefore, no human reader studies or AI assistance evaluations were performed or are relevant.

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

Not applicable. This is not an algorithm or software device. The "standalone" performance here refers to the device's inherent mechanical and biological performance in the animal model and bench tests without human intervention in its function once deployed.

7. The Type of Ground Truth Used:

• Efficacy: Direct physiological measurements (occlusion time), gross and microscopic examination of vessel pathology (endothelialization, attachment to vessel wall), and observation for recanalization in the live animal model.
• Mechanical & Biocompatibility: Standard engineering tests (pull tests, elongation, luer testing, advancement force) and validated biocompatibility assays.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. There is no training set for this physical device.

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