(84 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 and venous embolizations in the peripheral vasculature.
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-Traker 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 10 Detachment Controller. The implant segment detaches upon activation of the Detachment Controller.
The provided text describes a 510(k) premarket notification for the MicroPlex Coil System - Cosmos, a neurovascular embolization device. The submission aims to demonstrate substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Bench Testing | 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 Data Provenance
The document does not provide details on the specific sample sizes used for each of the bench tests. It also does not specify the data provenance (e.g., country of origin, retrospective or prospective) for these tests. The tests appear to be laboratory-based bench tests rather than clinical studies involving patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This document describes bench testing, not clinical studies involving human-derived ground truth. Therefore, information about the number or qualifications of experts establishing ground truth for a test set is not applicable and not provided. The "ground truth" for the bench tests would have been the technical specifications and expected performance defined by the manufacturer for each test.
4. Adjudication Method for the Test Set
Since the document focuses on bench testing and not human interpretation of data, an adjudication method (such as 2+1 or 3+1) is not applicable and not mentioned. The tests would have been evaluated against predefined technical specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not conducted or reported in this document. This submission is a 510(k) for a device, and the focus is on demonstrating substantial equivalence through bench testing, not on comparative effectiveness with human readers or AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This document is about a physical neurovascular embolization device, not an algorithm or AI system. Therefore, a "standalone algorithm performance" study is not applicable and not mentioned.
7. The Type of Ground Truth Used
For the bench tests, the "ground truth" used was the established criteria/specifications for each test, as determined by the manufacturer based on engineering and design requirements. This is inferred from the "Met established criteria" results. It's not expert consensus, pathology, or outcomes data in the clinical sense.
8. The Sample Size for the Training Set
This document describes a medical device, not an AI model. Therefore, the concept of a "training set" in the context of machine learning is not applicable and not mentioned.
9. How the Ground Truth for the Training Set Was Established
As this document does not pertain to an AI model, the concept of a training set and its ground truth establishment is not applicable and not mentioned. The "ground truth" for the device's design and manufacturing would be based on engineering principles, material science, and performance specifications.
§ 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).