(104 days)
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 Pushable 18 & 35 coils are made of platinum alloy (Pt/W: 92/8) with an outer layer of hydrogel polymer with an added over-coil. The over-coil is comprised of a 0.00125" platinum alloy (Pt/W: 92/8) wire which is wound over the hydrogel polymer and two ends are bonded to the main coil with the same DYMAX adhesive used in the existing AZUR Pushable 18 & 35 coils. The over-coil materials and manufacturing processes are also the same as those used in the manufacture of the HES (K0509054) coils. The implant segment is then attached to the delivery pusher. The pusher is inserted into detachment controller which when activated detaches the coil from the delivery ousher
The provided text describes the AZUR Coil System - Pushable 18 & 35 and its acceptance criteria, which are based on bench testing for substantial equivalence to predicate devices. However, the document does not contain information about a study that assesses a device's performance in diagnosing or classifying a condition (e.g., in terms of sensitivity, specificity, accuracy), nor does it mention the use of AI or human readers. Therefore, many of the requested fields cannot be extracted from the given text.
Here is the information that can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
| Bench Testing | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Simulated Use | - | Met established criteria |
| Advancement / Retraction Force | - | Met established criteria |
| Note: The specific established criteria are not detailed in the provided text, only that they were met. |
2. Sample size used for the test set and the data provenance
The document describes bench testing, not a clinical study on a patient population. Therefore, there is no information about a test set sample size or data provenance in the context of clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as this was bench testing, not a study requiring expert-established ground truth for a test set.
4. Adjudication method for the test set
Not applicable.
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 such study is mentioned or implied. The device is a vascular embolization device, not an AI diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable.
7. The type of ground truth used
For the bench testing, the "ground truth" would be the established engineering and performance specifications for the device's physical properties (e.g., advancement/retraction force, performance in simulated use).
8. The sample size for the training set
Not applicable, as this was bench testing for a physical device, and not an AI algorithm.
9. How the ground truth for the training set was established
Not applicable.
§ 870.3300 Vascular embolization device.
(a)
Identification. A vascular embolization device is an intravascular implant intended to control hemorrhaging due to aneurysms, certain types of tumors (e.g., nephroma, hepatoma, uterine fibroids), and arteriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in neurovascular applications are also not included in this classification, see § 882.5950 of this chapter.(b)
Classification. Class II (special controls.) The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices.” For availability of this guidance document, see § 870.1(e).