(24 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 Microcoil System consists of an embolic coil ("Microcoil") attached to a Device Positioning Unit (DPU) (single use, sterile)
The provided text is a 510(k) premarket notification for the Micrus Microcoil System DELTAPLUSH. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a study with acceptance criteria for a new device's performance.
Therefore, the document does not report acceptance criteria or a study designed to prove the device meets acceptance criteria in the way you've outlined for a typical diagnostic or AI-driven medical device.
Instead, the submission for the Micrus Microcoil System DELTAPLUSH makes the following claims:
- Comparison to Predicate Devices: "The Microcoil System, DELTAPLUSH, has shown substantial equivalence to the Micrus Microcoil System, Deltapaq, in terms of intended use, design, material of construction, implant dimensions including wire dimensions, coil dimensions, coil pitch, and coil stiffness. The DELTAPLUSH 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."
- 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 DELTAPLUSH Microcoil System is substantially equivalent to the predicate device in safety and effectiveness."
In summary, the information requested in your prompt (Table of acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) is not applicable or available in the provided 510(k) document for this specific device.
The 510(k) process for this device relies on demonstrating that the new device ("DELTAPLUSH") is as safe and effective as a previously cleared device ("Deltapaq") through non-clinical testing and comparison of attributes, rather than a prospective clinical study with defined performance metrics and acceptance thresholds.
§ 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).