(84 days)
The AXIUM™ DETACHABLE COIL SYSTEM is indicated for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities, such as arteriovenous malformations and arteriovenous fistulae. The AXIUM™ DETACHABLE COILS are also indicated for arterial and venous embolizations in the peripheral vasculature.
The AXIUM™ DETACHABLE COIL SYSTEM consists of a platinum coil secured to a composite delivery wire and is compatible with a 2-marker band micro catheter and a mechanical detachment system. The AXIUM™ coil configurations include bare platinum, PGLA laced platinum and Nylon laced platinum coils. The AXIUM™ DETACHABLE COIL SYSTEM consists of three components: 1- Implantable Coil, 2- Implant Delivery Pusher, 3- Instant Detacher (called the LRS (Linear Release System) actuator in K060747). The Instant Detacher is packaged and sold separately.
The provided text describes a medical device, the AXIUM™ DETACHABLE COIL SYSTEM, and its regulatory clearance process, focusing on an expanded indication for use. However, it does not include detailed acceptance criteria or a specific study proving the device meets acceptance criteria in the way typically required for AI/algorithm performance.
The document is a 510(k) summary for a medical device (a coil system for embolization), which focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific quantitative metrics through a clinical trial or algorithm validation study.
Therefore, many of the requested bullet points regarding acceptance criteria, sample sizes for test/training sets, expert involvement, and comparative effectiveness studies are not applicable or cannot be extracted from this document, as it pertains to a physical medical device, not an AI or algorithmic medical device.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Not applicable / Cannot be extracted from this document. This document is for a physical medical device's 510(k) clearance, not an AI or algorithmic device. It does not provide quantitative acceptance criteria or performance metrics in the context of an algorithm's output (e.g., sensitivity, specificity, accuracy). The "Performance Data" section refers to bench and animal testing for the physical device, not for an algorithm.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable / Cannot be extracted from this document. This document does not discuss a "test set" in the context of validating an algorithm. The performance data mentioned (bench and animal testing) relates to the physical device. The information about sample sizes or data provenance for such studies is not detailed here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable / Cannot be extracted from this document. This document does not describe the establishment of ground truth for an algorithmic test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Cannot be extracted from this document. This document does not involve an algorithmic test set or adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable / Cannot be extracted from this document. This device is a physical embolization coil system, not an AI-assisted diagnostic or treatment planning system. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable / Cannot be extracted from this document. This device is a physical medical implant, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable / Cannot be extracted from this document. As there's no algorithm involved, there's no "ground truth" to establish for an algorithm's performance. The "performance data" refers to the physical characteristics and safety of the implant itself, likely validated through engineering tests, animal studies, and comparison to predicate devices, rather than a diagnostic ground truth.
8. The sample size for the training set
- Not applicable / Cannot be extracted from this document. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established
- Not applicable / Cannot be extracted from this document. There is no "training set" or corresponding ground truth for an algorithm.
§ 870.3300 Vascular embolization device.
(a)
Identification. A vascular embolization device is an intravascular implant intended to control hemorrhaging due to aneurysms, certain types of tumors (e.g., nephroma, hepatoma, uterine fibroids), and arteriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in neurovascular applications are also not included in this classification, see § 882.5950 of this chapter.(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 § 870.1(e).