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The AZUR Peripheral Coil System is intended to reduce or blood flow in vessels of the peripheral vasculature. It is intended for use in the interventional radiologic management of arteriovenous malformations, arteriovenous fistulae, aneurysms, and other lesions of the peripheral vasculature.

The AZUR CX Detachable 18 Peripheral Coil System consists of an implantable coil attached to a delivery pusher.

The implantable coil is made of platinum alloy with an inner hydrogel core. The implantable coils are designed in 3D spherical structure in various loop sizes and lengths. They are delivered to the treatment site through the microcatheter. The proximal end of the delivery pusher is inserted to the AZUR Detachment Controller, which is activated by the user and this detaches the coil. The AZUR Detachment Controller is packaged and sold separately.

The provided document is a 510(k) summary for the AZUR CX Detachable 18 Peripheral Coil System, which is a vascular embolization device. This type of document is a premarket notification for a medical device and primarily focuses on demonstrating "substantial equivalence" to a predicate device rather than providing a detailed clinical study with acceptance criteria for device performance as one might find for a novel diagnostic AI algorithm.

Therefore, the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, which are typical for AI/diagnostic device validation, are not directly addressed in this regulatory submission for a physical embolization coil.

However, I can extract the relevant information that is present and indicate where the requested information is not applicable or not provided.

Here's an analysis of the document in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not provide a table of acceptance criteria and reported device performance in the context of clinical endpoints or diagnostic accuracy, as it's a submission for a physical medical device (an embolization coil) seeking substantial equivalence, not a diagnostic AI algorithm. The "performance" here refers to physical and mechanical characteristics tested against the predicate device.

The document states: "Bench testing was undertaken to demonstrate the substantial equivalence of the subject device to the AZUR CX Detachable 18 Peripheral Coil System when used according to the Instructions for Use."

The evaluations included:

• Visual Inspection
• Simulated Use Testing
• Advance/Retract force testing

While specific acceptance criteria (e.g., maximum force, defect rate for visual inspection) are not detailed in this summary, they would have been defined internally by MicroVention as part of their design verification and validation program. The "reported device performance" in this context would be that the device met these internal criteria, allowing the manufacturer to conclude substantial equivalence.

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

This information is not provided in a way that aligns with testing a diagnostic AI algorithm. For a physical device like this, "test set" would refer to the number of coils or components tested in bench studies. The document does not specify the sample size for the visual inspection, simulated use testing, or advance/retract force testing.

Data provenance (country of origin, retrospective/prospective) is not applicable here as these are bench tests, not clinical studies with patient data.

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

Not applicable. For a physical device like an embolization coil, "ground truth" isn't established by experts in the sense of image interpretation or diagnosis. Performance is measured mechanistically (e.g., force required, visual defects, successful deployment in a simulated vessel). While engineers and technicians would conduct and assess these tests, they are not "experts establishing ground truth" in the diagnostic sense.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1 or 3+1) are used for resolving discrepancies in expert interpretations, typically in diagnostic studies. Here, the tests are objective physical measurements and observations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

Not applicable. An MRMC study compares human readers' performance, often with and without AI assistance. This document is for a physical medical device (embolization coil), not a diagnostic algorithm, and therefore such a study was not performed or necessary for this submission.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

Not applicable. This is not an algorithm, so "standalone performance" doesn't apply.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance would be:

• Engineering specifications / Design Requirements: The device correctly performs its intended mechanical functions within predefined tolerances (e.g., specific force required for detachment, absence of visual defects).
• Comparison to Predicate Device: The subject device performs similarly or equivalently to the predicate device in the tested physical and mechanical characteristics.

This is not "expert consensus, pathology, or outcomes data" in the typical sense for a diagnostic device.

8. The Sample Size for the Training Set

Not applicable. This is not an AI algorithm; there is no "training set."

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

Not applicable. As above, there is no training set for this type of device.

Summary of Device and Study Focus from the Document:

• Device: AZUR CX Detachable 18 Peripheral Coil System, a vascular embolization device.
• Purpose of Submission: To demonstrate "substantial equivalence" to a legally marketed predicate device (AZUR CX Detachable 18 Peripheral Coil System, K123384). This means showing the new device is as safe and effective as the predicate and does not raise new questions of safety or effectiveness.
• Key Design Changes (Line Extension): Primarily changes in coil outer diameter (from 4-20mm to 2-3mm) and coil length (from 13-40cm to 2-8cm), and catheter compatibility.
• Study Type: Pre-clinical bench testing.
• Tests Performed: Visual Inspection, Simulated Use Testing, Advance/Retract force testing.
• Conclusion: The manufacturer concluded that the subject device is substantially equivalent to the predicate device based on these tests, and any differences in technological characteristics do not raise new concerns of safety or effectiveness.

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