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Numen™ Coil Embolization System is intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.

Numen™ Coil Embolization System is indicated for endovascular embolization of:

-Intracranial aneurysms

-Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae -Arterial and venous embolizations in the peripheral vasculature

NumenFR™ Detachment System is intended for use with MicroPort NeuroTech Numen™ Coil Embolization System in the embolization of intracranial aneurysms and other vascular abnormalities of the neuro and peripheral vasculature.

MicroPort NeuroTech has developed the Numen™ Coil Embolization System and NumenFR™ Detachment System. The Numen™ Coil Embolization System is designed to be used in conjunction with the NumenFRTM Detachment System (sold separately) for endovascular embolization of vascular abnormalities described in the intended use.

The Numen™ Coil Embolization System is composed of two parts as described below:

• . An introducer sheath: The function of the introducer sheath is to facilitate introduction of the coil into the microcatheter.
• . The coil system: The coil system is composed of a pusher and coil implant. The coil is a permanent implant intended to occlude blood flow in vascular abnormalities. The pusher is used to deliver the coil implant to the target lesion.

The MicroPort NeuroTech NumenFRTM Detachment System is a sterile, handheld, single-patient use device designed for use with the MicroPort NeuroTech Numen™ Coil Embolization System. The device is operated by two pre-loaded batteries.

The provided text describes a 510(k) premarket notification for a medical device, the Numen™ Coil Embolization System and NumenFR™ Detachment System. The document details the device, its intended use, comparison to a predicate device, and performance testing. However, it does not describe acceptance criteria for a study proving the device meets those criteria in the context of an Artificial Intelligence/Machine Learning (AI/ML) powered medical device.

The "Performance Testing" section (page 6) outlines bench testing conducted to evaluate device changes and demonstrate substantial equivalence to a predicate device. This is typical for traditional (non-AI/ML) medical devices, focusing on physical and functional properties, rather than AI performance metrics like sensitivity, specificity, or reader agreement.

Therefore, I cannot fulfill your request to describe acceptance criteria and a study demonstrating an AI/ML device's performance based on the provided text, as the text pertains to a different type of medical device assessment.

If you can provide a document that discusses the evaluation of an AI/ML medical device, I would be happy to analyze it according to your requested criteria.

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