(14 days)
The Azur Peripheral HydroCoil Endovascular Embolization Coil 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™ Peripheral HydroCoil® Endovascular Embolization System- Pushable 18 coils consist of an implantable coil packaged in an introducer along with a stylet. The stainless steel stylet is used to deploy the coil from the introducer into the delivery catheter. The coil is delivered to the treatment site through the delivery catheter using a standard guidewire. The Azur™ coil is platinum-based with a hydrogel polymer layer.
The provided text describes a medical device, the Azur™ Peripheral HydroCoil® Endovascular Embolization System - Pushable 18, and its regulatory clearance process, specifically related to substantial equivalence to predicate devices. It does not contain information about a study that assesses the device's performance against specific quantitative acceptance criteria or its effectiveness in a clinical setting.
Therefore, most of the requested information cannot be extracted directly from this document.
Here's what can be inferred and what is not available based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Visual Inspection | Met established criteria |
| Dimensional Measurement | Met established criteria |
| Simulated Use | Met established criteria |
| Advancement force | Met established criteria |
| Distal tip tensile test | Met established criteria |
| Proximal tip tensile test | Met established criteria |
| Body coil tensile test | Met established criteria |
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 document. The "Verification and Test Summary Table" lists various bench tests, but does not specify sample sizes or data provenance.
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 information is not provided as there is no mention of a clinical test set or human expert involvement in establishing ground truth. The tests listed are bench tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided as there is no mention of a human-reviewed test set or adjudication.
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
This information is not provided. This document describes a medical device for embolization, not an AI-assisted diagnostic tool or an imaging device directly involving human readers for interpretation. Therefore, an MRMC study as described is not relevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not provided. This device is not an algorithm but a physical medical implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the listed bench tests would be the established engineering specifications or performance standards for each test. For example, for "Visual Inspection," the ground truth would be that the device has no visible defects according to a defined spec. For "Dimensional Measurement," the ground truth would be that the dimensions fall within a specified range. These are not clinical "ground truths" like pathology or expert consensus.
8. The sample size for the training set
This information is not provided. This device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
This information is not provided as there is no AI/ML training set.
§ 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).