(79 days)
The MicroPlex Coil System is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The MCS is also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial.
The Cosmos consist of an implant coil made of platinum alloy. The coils are designed in 3D spherical structure in various loop sizes and lengths. The coil is attached to a V-Trak™ MCS delivery pusher via a polymer filament. The delivery pusher contains radiopaque positioning markers at the distal end. The proximal end is inserted into a hand held battery powered V-Grip™ Detachment Controller. The implant segment detaches upon activation of the Detachment Controller.
The provided 510(k) summary describes a neurovascular embolization device, the MicroPlex Coil System - Cosmos, and primarily focuses on demonstrating its substantial equivalence to a predicate device through bench testing. As such, the study does not involve AI or human reader performance.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Visual Inspection | Established criteria | Met established criteria |
| Dimensional Measurement | Established criteria | Met established criteria |
| Simulated Use | Established criteria | Met established criteria |
| Detachment Test | Established criteria | Met established criteria |
| Detachment Zone Tensile | Established criteria | Met established criteria |
| Advancement/Retraction Force | Established criteria | Met established criteria |
| Coil to Coupler Weld Tensile | Established criteria | Met established criteria |
| Spring Constant | Established criteria | Met established criteria |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes used for each bench test. The data provenance is laboratory-based testing of the device components. There is no information regarding country of origin of data or whether it was retrospective or prospective, as these are not relevant to bench testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Bench testing does not involve human experts to establish ground truth in the way clinical studies or AI performance validations do. The "ground truth" for bench tests is defined by established engineering and manufacturing specifications and test methods.
4. Adjudication method for the test set
Not applicable. Adjudication methods like "2+1" are used in clinical trials or evaluations where there's subjectivity and disagreement among human reviewers. Bench tests follow objective, predefined protocols and measurements.
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 multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a physical medical device (neurovascular embolization coil), not an AI-powered diagnostic or assistive tool. Therefore, there is no discussion of human reader improvement with or without AI assistance.
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 device is a physical medical device, not an algorithm.
7. The type of ground truth used
The ground truth used for these bench tests would be the pre-defined engineering specifications, material properties, and functional performance requirements for the device. These are objective and measurable parameters established during the device's design and development.
8. The sample size for the training set
Not applicable. This device is not an AI algorithm, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for a physical medical device.
§ 882.5950 Neurovascular embolization device.
(a)
Identification. A neurovascular embolization device is an intravascular implant intended to permanently occlude blood flow to cerebral aneurysms and cerebral ateriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in other vascular applications are also not included in this classification, see § 870.3300.(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 § 882.1(e).