(138 days)
The Micrus Microcoil Delivery System is intended for endovascular embolization of intracranial aneurysms, other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae, and are also intended for arterial and venous embolizations in the peripheral vasculature.
The Micrus Deltapaq 10 Stretch-Resistant Microcoil Systems consists of an embolic coil ("Microcoil") attached to a Device Positioning Unit (DPU) (single use, sterile)
The provided document is a 510(k) summary for the Micrus Deltapaq 10 Stretch-Resistant Microcoil System, a neurovascular embolization device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing a de novo clinical trial with specific acceptance criteria and detailed performance studies against a defined ground truth.
Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, device performance against those criteria, details of a study with a test set, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment relevant to an AI/ML device.
Instead, the document emphasizes the following:
1. Comparison to Predicate Device:
The submission states: "The Micrus Deltapaq 10 Stretch-Resistant Microcoil System has shown substantial equivalence to the Micrus Stretch-Resistant Microcoil System in terms of intended use, design, material of construction, implant dimensions including wire dimensions, coil dimensions, coil pitch, and coil stiffness. The Deltapaq 10 Stretch-Resistant microcoils use the same method and material of construction, packaging, and sterilization method as its predicate. The modification has not altered the fundamental technology of the sponsor's predicate device."
2. Conclusion:
"Based upon the design, materials, function, intended use, comparison with currently marketed devices and the non-clinical testing performed by Micrus Endovascular Corporation, it is concluded that the Micrus Deltapaq 10 Stretch-Resistant Microcoil System is substantially equivalent to the predicate device in safety and effectiveness."
In summary, as this is a 510(k) submission for a non-AI/ML medical device, the detailed information about acceptance criteria, performance studies with test sets, expert ground truth, and training data as typically required for AI/ML device evaluations is not present in this document. The "study" here refers to non-clinical testing demonstrating equivalence to a predicate device, rather than a performance study against specific diagnostic or prognostic metrics.
§ 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).