(28 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 Peripheral Coil System - Detachable 35 consists of an implantable coil attached to a delivery pusher. The coil system is delivered to the treatment site through the microcatheter. The detachment controller is activated by the user and this detached the coil. The detachment controller utilizes battery power to detach the coils from the delivery pusher.
This 510(k) submission describes the AZUR Peripheral Coil System - Detachable 35, a vascular embolization device. The document primarily focuses on demonstrating substantial equivalence to a predicate device through bench testing rather than clinical study.
Here's an analysis of the provided information, addressing your specific points:
1. A table of acceptance criteria and the reported device performance
| Test Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Dimensional Measurement | Established criteria (not specified) | Met established criteria |
| Simulated Use | Established criteria (not specified) | Met established criteria |
| Device Repositioning | Established criteria (not specified) | Met established criteria |
| Device Detachment | Established criteria (not specified) | Met established criteria |
| Advance / Retract Force | Established criteria (not specified) | Met established criteria |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document explicitly states "Bench Testing" for the verification and test summary. This indicates that the tests were conducted in a laboratory setting, not on human or animal subjects. Therefore, there is no "test set" in the context of clinical data, no country of origin of data, and it is neither retrospective nor prospective in the clinical sense. The sample sizes for each bench test are not specified in the provided document.
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)
Since the study involved bench testing and not clinical evaluation or human interpretation of data, there were no experts used to establish ground truth in the way you describe for a clinical test set. The acceptance criteria for the bench tests would have been pre-defined engineering or quality standards, likely set by the manufacturer's engineers and quality control personnel.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As this was bench testing, there was no adjudication method as typically applied to a clinical test set involving expert review. The performance was measured against pre-defined engineering 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
No, a MRMC comparative effectiveness study was not done. This device is a physical medical device (vascular embolization coil), not an AI-powered diagnostic or decision support system. Therefore, the concept of human readers improving with or without AI assistance is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm-only performance study was not done. This is a physical medical device, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the bench testing, the "ground truth" would be the established engineering specifications or performance parameters that the device was designed to meet. These criteria are not detailed in the summary but are implied to have been "established criteria" that the device "Met."
8. The sample size for the training set
Not applicable. This document describes the testing and regulatory submission for a physical medical device. The concept of a "training set" is relevant for machine learning or AI models, which are not involved here.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
§ 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).