(281 days)
Ultra IVALON and Ultra DRIVALON PVA Embolization Particles are intended for the embolization of hypervascular tumors and arteriovenous malformations (AVMs).
Ultra IVALON and Ultra DRIVALON PVA Embolization Particles are artificial embolization devices used for permanent embolization of hypervascular lesions and arteriovenous malformations (AVMs) via superselective catheter delivery. The embolization particles are supplied in various size ranges to enable appropriate size selection for the lesion to be treated. Ultra IVALON and Ultra DRIVALON PVA Embolization Particles are designed to be delivered under fluoroscopic guidance through compatible infusion/delivery catheters. Ultra IVALON PVA Embolization Particles are suspended in 0.9% saline (NaCI) solution. Uttra DRIVALON PVA Embolization Particles are packaged in a dry form. Each unit contains 0.1g of particles.
The provided text describes a 510(k) premarket notification for the "Ultra IVALON and Ultra DRIVALON PVA Embolization Particles." It mainly focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with specific acceptance criteria and performance metrics for the new device. Therefore, much of the requested information cannot be extracted directly from this document.
Here's an attempt to answer the questions based only on the provided text, indicating where information is not available:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state numerical acceptance criteria or specific performance metrics for the Ultra IVALON and Ultra DRIVALON PVA Embolization Particles. The "Non-clinical Test Results" section vaguely states: "Testing has shown the subject device to be safe and effective for its intended use." This is considered a general claim of performance rather than a quantified report against specific criteria.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Not specified | Not specified quantitatively, but stated as "safe and effective for its intended use." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document refers to "testing" generically, without detailing the nature of the test set, sample sizes, or data provenance.
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)
This information is not provided in the document. The document mainly focuses on regulatory aspects of substantial equivalence, not on a clinical or performance study involving expert consensus or ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
This information is not provided in the document. The filing is for an embolization particle device, not an AI or imaging diagnostic device that would typically undergo MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not provided in the document. As mentioned, this is not an AI or algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided in the document.
8. The sample size for the training set
This information is not provided in the document. The document describes a medical device (embolization particles), not a machine learning model that would have a training set.
9. How the ground truth for the training set was established
This information is not provided in the document. This concept is not applicable to the type of device described.
§ 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).