(171 days)
The MicroPlex Coil System (MCS) is intended for embolization of those intracranial aneurysms that - because of their morphology, their location, or the patient's general medical condition - are considered by the treating neurosurgical team to be very high risk for management by traditional operative techniques or inoperable. The MCS is also intended for embolization of other neuro-vascular abnormalities such as arteriovenous malformations and arteriovenous fistulae and for arterial and venous embolizations in the peripheral vasculature.
The MicroVention MicroPlex Coil System (MCS) consists of an implantable coil attached to a fluid injection delivery system called a Delivery Pusher. The Delivery Pusher consists of a variable stiffness tube with a retention sleeve that attaches the pusher to the implantable coil. A peel-away introducer sheath assists in the delivery of the implantable coil into the microcatheter.
The MCS-CC is a platinum complex coil that establishes the initial framework in the treatment of vascular abnormalities (e.g., intracranial aneurysms). The MCS-HC is a platinum helical coil that provides additional filling once the initial framework has been established by one or more complex coils. The complex and helical coils are provided in a number of diameters and lengths. The MCS-HCP is a platinum helical coil with an outer layer of a hydrophilic, acrylic polymer that also provides additional filling once the initial framework has been established by placement of one or more MCS-CC complex coils.
The MCS-CC and MCS-HC are available in 18- and 10-compatible systems. The 18compatible systems may be delivered through 14- and 18-type micro-catheters. The 10compatible systems may be delivered through 10- and 14-type micro-catheters. The MCS-HCP is available in 14-compatible systems and may be delivered through 14-type micro-catheters.
The provided text is a 510(k) premarket notification for a medical device, the MicroPlex™ Coil System (MCS). This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific acceptance criteria through a clinical study in the way a PMA (Premarket Approval) might require.
Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria, especially in the context of an AI/algorithm-based device. The document is for a physical embolization coil system.
Here's a breakdown of why the requested information cannot be extracted from the provided text, based on the nature of a 510(k) for a physical medical device:
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Table of acceptance criteria and reported device performance: This document does not present specific acceptance criteria in a quantitative table format. It states that "Performance testing including tensile strength, coil detachment, simulated use, biocompatibility and animal testing demonstrated that the MicroPlex Coil System (MCS) has equivalent performance to the predicate devices." This implies that the performance was deemed acceptable if it was equivalent to the predicate, but no specific numerical targets or results are provided.
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Sample size used for the test set and data provenance: Not applicable. The "test set" here refers to the physical device being tested (e.g., coils for tensile strength). The document does not specify sample sizes for these tests, nor the provenance of such "data" in the epidemiological sense.
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Number of experts used to establish ground truth & qualifications: Not applicable. Ground truth, in the context of AI or diagnostic studies, refers to the definitive determination of a condition. For a physical device like an embolization coil, ground truth would be established through engineering tests, material science evaluations, and potentially animal studies, not typically by human experts adjudicating cases of patient data as described.
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Adjudication method: Not applicable, as there's no diagnostic task involving human expert review of cases.
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Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This type of study is relevant for diagnostic devices (especially those involving image interpretation by human readers, sometimes aided by AI) to assess inter-reader variability and the impact of the device on reader performance. The MCS is a therapeutic device.
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Standalone (algorithm only) performance: Not applicable. The MCS is a physical medical device, not an algorithm.
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Type of ground truth used: For the performance tests mentioned (tensile strength, coil detachment, simulated use, biocompatibility, animal testing), the "ground truth" would be established by the physical measurements, chemical analyses, and physiological responses observed in the animal models, rather than expert consensus, pathology, or outcomes data from human subjects in a clinical trial for a diagnostic device.
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Sample size for the training set: Not applicable. The MCS is not an AI/ML algorithm that requires a training set.
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How the ground truth for the training set was established: Not applicable.
In summary, the provided document is a 510(k) notification for a physical medical device. The types of questions asked are highly specific to AI/ML software as a medical device (SaMD) or diagnostic devices that involve human interpretation. This document does not contain information relevant to those types of questions.
§ 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).