(270 days)
EmboCube Embolization Gelatin is indicated for use in embolization of:
- Hypervascular tumors
- Blood vessels to occlude blood flow to control bleeding / hemorrhaging in the peripheral vasculature
EmboCube Embolization Gelatin is a hydrophilic, medical device which consists of pre-cut, dry cubes of resorbable gelatin sponge packaged in a syringe. The device is available in 2 cube sizes and 3 weight configurations. Once rehydrated, the deformable cubes can be injected into the target vessel with an intravascular catheter or a micro-catheter (depending on the size range) to provide a mechanical barrier to blood flow. Contrast enhancement may be used to monitor the embolization procedure using fluoroscopy. The device is intended for single use and is provided sterile.
The provided text is a 510(k) summary for the EmboCube Embolization Gelatin and does not contain information about the acceptance criteria and study proving a device meets these criteria for an AI/ML-based medical device.
This document is for a physical medical device, an embolization gelatin, and details its substantial equivalence to a predicate device. Therefore, it discusses performance attributes relevant to a physical medical implant (e.g., macroscopic appearance, digestibility, size range, density, moisture content, sterility, pyrogenicity, shelf-life, deliverability) and includes details about an animal study to evaluate its performance (immediate control of bleeding, complications, re-bleeding rate).
The request, however, asks for information typically associated with the validation of an AI/ML medical device, such as:
- Acceptance criteria and reported device performance (in an AI/ML context, this would involve metrics like sensitivity, specificity, AUC).
- Sample sizes for test sets, data provenance (retrospective/prospective, country of origin).
- Number and qualifications of experts for ground truth establishment.
- Adjudication methods.
- MRMC studies and human reader improvement with AI assistance.
- Standalone algorithm performance.
- Types of ground truth (expert consensus, pathology, outcomes data).
- Training set sample size and ground truth establishment for training.
Since the provided document is about a physical medical device and not an AI/ML device, it does not contain any of the information necessary to address the specific points in the prompt related to AI/ML device validation.
§ 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).