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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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Used for peripheral arterial and venous vessel embolization procedures.

The MReye® Embolization Coil is supplied sterile and is intended for one time use. The embolization coil is pre-loaded in a shipping cannula. The coil is constructed of Inconel and has wire diameters of 0.025, 0.035, and 0.038 inches. It is available in curled and straight shapes. The emboli size range is 0 mm (straight) to 15 mm. The embolization coil includes synthetic fibers evenly placed down the length of the coil. The device is introduced to the target vessel using an angiographic catheter (sold separately) and deployment is achieved by a wire guide (sold separately) pushing the coil out of the catheter.

This document describes a 510(k) premarket notification for the MReye® Embolization Coil. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that a device meets specific performance criteria through clinical studies or detailed algorithm evaluations.

Therefore, the requested information about acceptance criteria, detailed study design, sample sizes, expert involvement, and ground truth establishment, which are typical for studies assessing AI/ML device performance or clinical effectiveness studies for novel devices, is not present in this 510(k) submission.

Here's an explanation based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not provide a table of acceptance criteria with specified quantitative thresholds for performance metrics. Instead, it lists the types of tests performed to ensure reliable design and performance, and generally states that the results provide "reasonable assurance" of conformance.

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

Not applicable. This submission is for a medical device (embolization coil), not an AI/ML diagnostic or prognostic algorithm that uses test sets with patient data. The "tests" mentioned are engineering and material compatibility tests, not clinical studies with patient data.

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

Not applicable. This information is relevant for studies where human expert review establishes a "ground truth" for comparison, typically in AI/ML performance evaluations or clinical trials. This 510(k) focuses on the physical and material characteristics of the coil.

4. Adjudication Method

Not applicable for the same reasons as points 2 and 3.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed or reported in this submission. This type of study is designed to assess how human readers' performance changes with AI assistance, which is not applicable to a physical medical device like an embolization coil.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No, a standalone study evaluating an algorithm's performance was not performed. This device is a physical embolization coil, not a software algorithm.

7. Type of Ground Truth Used

Not applicable. The "ground truth" concept (e.g., pathology, outcomes data, expert consensus) is typically used in the context of diagnostic or prognostic evaluations, often involving imaging or other patient data. The tests performed for this device relate to its physical and material properties.

8. Sample Size for the Training Set

Not applicable. The concept of a "training set" is relevant for machine learning algorithms. This submission is for a physical medical device.

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

Not applicable for the same reasons as point 8.

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