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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, atteriovenous fistulae, aneurysms, and other lesions of the peripheral vasculature.

The Detachable AZUR HydroPack 18 Peripheral Coil System with a controlled detachable delivery method consists of an implantable coil, a delivery pusher, and a Detachment Controller (sold separately). The implantable coils are made of platinum alloy with a hydrogel inner core. The coil is attached to the delivery pusher via a polyolefin elastomer filament. The coil implant is delivered to the target treatment site through a microcatheter which has an inner dimension that is compatible with the selected AZUR HydroPack 18 Peripheral Coil System. The proximal end of the delivery pusher is inserted into the hand-held battery powered AZUR Detachment Controller. When the implantable coil has been successfully placed in the desired location, the AZUR Detachment Controller is activated and a flow of electrical current heats the polyolefin elastomer filament, resulting in detachment of the implantable coil. The AZUR Detachment Controller is packaged and sold separately.

The provided text describes a 510(k) premarket notification for a medical device, the AZUR HydroPack 18 Peripheral Coil System (Detachable). This type of submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving efficacy through clinical or comparative effectiveness studies in the same way an AI/ML device might.

Therefore, many of the requested categories for acceptance criteria and study details (like sample size for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, and even ground truth for training sets) are not applicable to this type of device clearance and submission. The performance data presented here is focused on engineering verification and validation of the device's physical properties and function.

Here's a breakdown of the available information:

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

The document does not explicitly list acceptance criteria values alongside reported device performance values. Instead, it states that testing was performed "to ensure that the modified device continues to meet the established design and performance specifications." The categories of tests performed are listed as the performance data.

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

This information is not provided in the summary. The tests are engineering verification and validation (V&V) tests, typically performed in a lab setting rather than clinical studies with human data.

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 is not applicable. Ground truth in the context of this device's V&V testing refers to engineering specifications and performance expectations, not clinical expert consensus on diagnostic or therapeutic outcomes.

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

This is not applicable. Adjudication methods are typically used in clinical studies involving interpretation of data by multiple experts. For engineering tests, results are typically measured against predefined limits and specifications.

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

An MRMC comparative effectiveness study was not done. This type of study is relevant for AI/ML diagnostic or assistive devices, which is not the case for this physical medical device.

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

This is not applicable. This is a physical vascular embolization device, not an algorithm or AI system.

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

The "ground truth" for the device's performance is its established design and performance specifications. For example, a "visual and dimensional inspection" test would have specifications for dimensions, and the ground truth would be those specified dimensions.

8. The sample size for the training set

This is not applicable. Training sets are used for AI/ML algorithms. This device underwent engineering verification and validation.

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

This is not applicable. As no training set was involved (this is not an AI/ML device), no "ground truth for the training set" was established.

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