(226 days)
Axium™ Detachable Coils are intended for the endovascular embolization of intracranial aneurysms. Axium™ Detachable Coils are also intended for the embolization of other neuro vascular abnormalities such as arteriovenous malformations and arteriovenous fistulae.
The Axium™ Prime Detachable Coils are intended for the endovascular embolization of intracranial anewrysms. The Axium™ Prime Detachable Coils are also intended for the embolization of other neuro vascular abnormalities such as arteriovenous malformations and arteriovenous fistulae.
The Axium™ Prime Detachable Coil is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities, such as arteriovenous malformations and arteriovenous fistulae. The Axium™ Prime Detachable Coils are also intended for arterial and venous embolizations in the peripheral vasculature.
The Axium™ Detachable Coil and Axium™ Prime Detachable Coil (referred to collectively as "Axium™ device family"), consists of a platinum embolization coil attached to a composite implant delivery pusher with a radiopaque positioning marker and a hand-held Instant Detacher (I.D.) which when activated detaches the coil from the delivery pusher tip. The Instant Detacher (I.D.) is sold separately.
This document does not describe an AI/ML device and therefore does not contain the information requested in your prompt regarding acceptance criteria and studies for AI/ML device performance.
The document is a 510(k) premarket notification summary for the Axium™ Detachable Coil and Axium™ Prime Detachable Coil, which are neurovascular embolization devices. It describes a proposed change to the labeling concerning the accessory sheath (from femoral to arterial, allowing radial access) and the removal of certain peripheral vasculature indications for specific models.
The performance data presented are for bench testing of the physical device (e.g., ease of delivery, detachment reliability, retractability, retrieval) and explicitly states:
- "The determination of substantial equivalence is based upon non-clinical bench testing as there is no change to the intended use, fundamental scientific technology, or materials of construction." (Regarding animal and clinical data).
Therefore, I cannot provide details on:
- A table of acceptance criteria and reported device performance for an AI/ML device.
- Sample sizes for test sets or data provenance for AI/ML model evaluation.
- Number and qualifications of experts for AI/ML ground truth.
- Adjudication methods for AI/ML test sets.
- MRMC studies or human reader improvement with AI assistance.
- Standalone performance of an algorithm.
- Type of ground truth used for AI/ML.
- Sample size for AI/ML training set.
- How ground truth for an AI/ML training set was established.
§ 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).