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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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The AZUR System is intended to reduce or block the rate of 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 Coil System - Detachable 18 Coils are made of platinum alloy with inner hydrogel core. The coils are designed in 3D spherical structure in various loop sizes and lengths which have the gel on all the loops. The implant segment is then attached to the delivery pusher is inserted into detachment controller which when activated detaches the coil from the delivery pusher. The detachment controller utilizes battery power to detach the coils from the delivery pusher. The coils are specified to be delivered through a microcatheter with a minimum inner diameter of 0.021" (0.053 mm).

Here's an analysis of the provided text regarding the Azur CX Coil System, focusing on the acceptance criteria and supporting studies.

Based on the provided text, the device is a Class II Vascular Embolization Device and the submission is a 510(k) premarket notification for a line extension. This means the primary goal of the submission is to demonstrate substantial equivalence to already legally marketed predicate devices, rather than proving novel effectiveness or efficacy through extensive clinical trials.

Therefore, the "acceptance criteria" and "studies" are primarily focused on bench testing to show that the new device performs similarly and safely to the predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that the data demonstrates "technological similarity and equivalency" and that the device "is, in our opinion, substantially equivalent" to the predicate devices. The specific quantitative acceptance thresholds for "Met established criteria" are not provided in this summary.

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

• Test Set Sample Size: Not specified. The document only mentions "Bench Testing" and does not provide details on the number of units tested for each criterion.
• Data Provenance: The studies are described as "Bench Testing," implying in-vitro, laboratory-based testing conducted by the manufacturer, MicroVention, Inc. (located in Tustin, California, U.S.A.). The data is prospective in the sense that MicroVention performed these tests for the submission, but they are not clinical studies on human subjects.

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

• Not Applicable. For a 510(k) submission based on bench testing for substantial equivalence, the "ground truth" is typically established by engineering specifications, validated test methods, and comparison against the performance of predicate devices. There is no mention of external human experts establishing ground truth for these bench tests in the provided document.

4. Adjudication Method for the Test Set

• Not Applicable. As the “studies” are in-vitro bench tests, there is no clinical data or expert review process that would require an adjudication method like those used for clinical trials or image interpretation. The testing results are likely evaluated against predetermined engineering specifications and predicate device performance.

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

• No. An MRMC study is a type of clinical study typically used to evaluate the diagnostic accuracy of a medical imaging device when interpreted by multiple human readers, often comparing performance with and without AI assistance. This submission is for a vascular embolization device, and the provided document only discusses bench testing for substantial equivalence, not a clinical effectiveness study of diagnostic image interpretation.

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

• Not Applicable. This device is a physical medical implant (a coil system for embolization), not an algorithm or AI software that would have a "standalone" performance. The "device" itself is the instrument being evaluated.

7. Type of Ground Truth Used

• Engineering Specifications and Predicate Device Performance. For the bench tests ("Simulated Use," "Detachment," "Advanccment / Retraction Force"), the "ground truth" or standard for acceptance would be based on:
  • Pre-defined engineering requirements and specifications for the device's mechanical and functional properties.
  • Demonstrating performance comparable to the predicate devices identified (K120630 and K071939).

8. Sample Size for the Training Set

• Not Applicable. This is not an AI or machine learning device that requires a "training set." The device is a physical medical implant.

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

• Not Applicable. (As above, no training set is relevant for this type of device submission.)

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