(118 days)
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 MCS Vector consists of an implantable coil made of bare platinum alloy. The Vector implantable coils has a 3D shape in various loop sizes and lengths. The coil is attached to a V-Trak delivery pusher. The proximal end is inserted into a hand held battery powered V-Grip Detachment Controller (sold separately). The implant segment detaches upon activation of the Detachment Controller.
Here's an analysis of the provided text regarding the acceptance criteria and study for the MicroPlex Coil System - Vector:
No clinical studies are mentioned in the provided text. This 510(k) summary primarily focuses on establishing substantial equivalence through bench testing and comparison of physical properties and intended use with predicate devices. Therefore, many of the requested categories related to clinical study design (sample size, ground truth, expert adjudication, MRMC studies, standalone performance) cannot be addressed from this document.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (Implicit: Met same as predicate) | Reported Device Performance |
|---|---|---|
| Dimensional Measurement | Met same criteria as predicate | Met same criteria as predicate |
| Simulated Use: | Met same criteria as predicate | Met same criteria as predicate |
| - Introduction | ||
| - Tracking | ||
| - Deployment | ||
| - Frame movement | ||
| - Microcatheter movement | ||
| - Microcatheter manipulation | ||
| - Compartmentalization | ||
| - Detachment | ||
| - Overall performance | ||
| Spring Constant | Met same criteria as predicate | Met same criteria as predicate |
| Weld Tensile Strength | Met same criteria as predicate | Met same criteria as predicate |
| Detachment Zone Tensile Strength | Met same criteria as predicate | Met same criteria as predicate |
Implicit Acceptance Criteria: The document states that the MicroPlex Coil System - Vector "Met same criteria as predicate" for all listed bench tests. This implies that the acceptance criteria for each test were the established performance benchmarks of the predicate devices: MicroPlex Coil System - Cosmos 10 (K082461, K093919, K103758) and MicroPlex Coil System - Cosmos 18 (K090891, K093358). The specific numerical values or ranges for these criteria are not provided in this summary.
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified. The document refers to "bench tests" but does not provide details on the number of samples tested for each criterion.
- Data Provenance: The study is in-vitro bench testing, not involving human data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This document describes bench testing, not a study requiring expert-established ground truth on patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. This document describes bench testing, not a study requiring adjudication of expert opinions on patient data.
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
- Not Applicable. No MRMC or human-in-the-loop study was described. This is a medical device for embolization, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a medical device for embolization, not an algorithm. Bench testing evaluates the physical and functional performance of the device itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Physical Benchmarks/Engineering Specifications: The "ground truth" for the bench tests would have been the established engineering specifications and performance characteristics of the predicate devices, which the new device aimed to match or exceed.
8. The sample size for the training set
- Not Applicable. This is a medical device, not an AI model, 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 an AI model, this question is not relevant.
In summary: The provided 510(k) summary for the MicroPlex Coil System - Vector demonstrates the device meets acceptance criteria through bench testing, specifically by showing that its physical properties and simulated use performance "met same criteria as predicate" devices. The document does not contain information about clinical trials, human data, AI performance, or expert adjudication, as it relies on substantial equivalence to previously cleared devices based on non-clinical performance data.
§ 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).