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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 Coils consist of implant coil made of platinum alloy with inner hydrogel core. The coils are designed in 3D spherical structure in various loop sizes and lengths. The AZUR CX Coil System (Detachable) consists of an implantable coil attached to a delivery pusher. The coil system is delivered to the treatment site through the microcatheter. The proximal end of the delivery pusher is inserted to the AZUR detachment controller. The detachment controller is activated by the user and this detaches the coil. The AZUR coils are designed for use with the AZUR Detachment Controller (Also known as AZUR Detachment Controller), specifically designed for coil detachment and is sold separately.

This document is a 510(k) premarket notification for a medical device called the AZUR CX Peripheral Coil System - Detachable 35. It describes the device, its intended use, and compares it to predicate devices to establish substantial equivalence.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance:

The document provides a "Verification of Test Summary" and "Biocompatibility Summary" which can be interpreted as the acceptance criteria and the results of tests performed.

Note: The document explicitly states "Passed" for bench tests. For biocompatibility, it lists test methods and standards, and the "Summary of Substantial Equivalence" implies that these tests were passed and support the equivalency claim.

2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

The provided document does not specify the sample sizes used for the bench tests or biocompatibility tests. It also does not provide information on the data provenance (e.g., country of origin, retrospective or prospective nature) for these tests. This information would typically be found in the detailed test reports, which are not included in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

This document describes a medical device, the AZUR CX Peripheral Coil System, which is an implantable coil for embolization. The tests conducted are primarily mechanical/physical bench tests and biocompatibility tests, not studies involving expert interpretation of medical images or clinical outcomes that would require a ground truth established by medical experts for a test set. Therefore, this question is not applicable in the context of the information provided.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

As the tests are primarily bench and biocompatibility tests, there is no adjudication method described or relevant for establishing a clinical "ground truth" for a test set by human experts. The results are typically objectively measured or observed (e.g., a "pass" or "fail" for a mechanical test, or quantitative results against a standard for biocompatibility).

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No MrMC comparative effectiveness study was done or is mentioned in this document. This filing is for a physical medical device (embolization coil), not an AI-powered diagnostic or assistive tool.

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

Not applicable. This device is a physical implant, not an algorithm, so standalone performance in the context of AI is irrelevant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the bench tests, the "ground truth" is defined by engineering specifications and performance requirements for the device's physical and functional characteristics. For biocompatibility tests, the "ground truth" is established by international standards (ISO 10993 series), which define acceptable biological responses to medical devices. There isn't a "ground truth" in the sense of clinical diagnoses or outcomes used in AI or clinical trials with human subjects.

8. The sample size for the training set:

Not applicable. The device is a physical medical implant, not an AI model that requires a training set.

9. How the ground truth for the training set was established:

Not applicable. As there is no AI model or training set, there is no ground truth to establish for a training set.

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