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MReye Embolization Coils are intended for use in peripheral arterial and venous vessel embolization procedures.

The MReye Embolization Coils are constructed from coiled Inconel (nickel chromium alloy) wire and synthetic fibers. The wire forms primary coil diameters from 0.025 to 0.038 inches, and the extended embolus lengths range from 1 to 20 cm. Upon exiting from the cartridge and the catheter. the coil forms a secondary curl diameter ranging from 0 (straight) to 45 mm.

This document is a 510(k) premarket notification for a medical device called "MReye® Embolization Coils." The purpose of the 510(k) is to demonstrate that the new device is substantially equivalent to a predicate device already on the market.

Based on the provided text, there is no information about acceptance criteria or a specific study proving the device meets acceptance criteria in the context of diagnostic performance (e.g., sensitivity, specificity, accuracy).

The document focuses on:

• Device Description: The physical composition and characteristics of the embolization coils.
• Intended Use: For peripheral arterial and venous vessel embolization procedures.
• Comparison to Predicate Device: States that the "MReye® Embolization Coils are identical in terms of intended use, principles of operation, materials of construction, and basic technological characteristics to the predicate device."
• Performance Data: Mentions "MRI Testing" was performed to verify that the implant will be labeled as "MR Conditional" with applicable parameters described in the Instructions for Use. This is a safety performance test related to MRI compatibility, not a diagnostic accuracy study for a device that interprets or processes medical images.

Therefore, I cannot populate the requested table and information beyond stating that the available text does not contain this kind of data.

Based on the provided text, the answer to your request is as follows:

There is no information regarding the acceptance criteria, device performance metrics (e.g., sensitivity, specificity, or accuracy), or a study design to assess such performance for a diagnostic device in the provided document.

This document is a 510(k) premarket notification for a vascular embolization device (MReye® Embolization Coils) and focuses on demonstrating substantial equivalence to a predicate device, primarily through material, design, and intended use comparison, along with MRI compatibility testing for safety. It is not a submission for an AI/ML-driven diagnostic device that would typically involve the type of performance studies you are asking about.

Therefore, I cannot provide the requested information for the following points as they are not present in the document:

• A table of acceptance criteria and the reported device performance
• Sample sizes used for the test set and data provenance
• Number of experts used to establish ground truth
• Adjudication method
• Multi-reader multi-case (MRMC) comparative effectiveness study
• Standalone performance study
• Type of ground truth used
• Sample size for the training set
• How ground truth for the training set was established

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