(36 days)
Embozene® Microspheres are intended for embolization of hypervascular tumors and arteriovenous malformations.
Embozene® Microspheres are tightly calibrated, compressible microspheres intended to occlude vasculature for the purpose of blocking blood flow to a target tissue such as hypervascular tumor (HVT) or arteriovenous malformation (AVM). Embozene® Microspheres are manufactured from sodium polymethacrylate and coated with proprietary Polyzene®-F. The microspheres are compressible to enable smooth delivery through the indicated delivery catheter. Embozene® Microspheres are color coded by size to allow easy identification of different sizes. Embozene® Microspheres are supplied sterile and packaged in 20ml polycycloolefin syringes with a standard 7ml fill volume across the range. Embozene® Microspheres syringes and vials are available with 1 ml or 2 ml microsphere volume per syringe or vial.
This document is a 510(k) summary for Embozene® Microspheres, describing their intended use, device description, and a comparison to a predicate device. It does not describe a study involving an AI device or a direct performance evaluation against acceptance criteria in the context of AI/ML. Instead, it focuses on demonstrating substantial equivalence to a previously cleared device.
Therefore, many of the requested elements for an AI device study are not present in the provided text. I will answer based on the information available and indicate when information is not extractable from the provided text.
1. A table of acceptance criteria and the reported device performance
The provided text describes a submission for demonstrating substantial equivalence for an existing device, Embozene® Microspheres, with the addition of new sizes (1100 µm and 1300 µm). It does not present acceptance criteria for a "device performance" in the typical sense of accuracy, sensitivity, or specificity as might be seen for an AI/ML device.
Instead, the "performance" here relates to demonstrating that the new sizes of the Embozene® Microspheres maintain the same characteristics and safety profile as the predicate device. The implicit acceptance criteria are that the new sizes are substantially equivalent to the cleared predicate device.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Same Indications for Use | Unchanged: Embolization of hypervascular tumors and arteriovenous malformations. |
| Same Design, Specifications, Fundamental Scientific Technology | The subject device and predicate have the same design, specifications, fundamental scientific technology, and packaging. The only change is the addition of 1100 µm and 1300 µm sizes. |
| Chemical Composition | Unchanged |
| Osmolarity of Transport Solution | Unchanged |
| pH of Transport Solution | Unchanged |
| Shelf Life | Same (3 years) |
| Sterility | Same (Pyrogen-free, sterile) |
| Packaging | Same (Syringe or vial) |
| Syringe Total Fill Volume | Same (7ml) |
| Microsphere Volume per Syringe | Same (1 or 2 ml) |
| Catheter Compatibility | Testing conducted on the subject device and concluded to be equivalent to the predicate. |
| Size Distribution | Testing conducted on the subject device and concluded to be equivalent to the predicate. Specific sizes and tolerances for the new sizes (1100 µm ± 75 µm and 1300 µm ± 75 µm) are provided, consistent with the predicate's sizing methodology. |
| Overall Safety and Effectiveness (Clinical Review) | Clinical evaluation included a review of scientific literature, unpublished data, and post-market surveillance over ten years. "Concluded that the benefits of TAE with Embozene microspheres family including the additional 1100 and 1300 µm microspheres for the treatment of hypervascular tumors and arteriovenous malformations outweigh the potential risk." |
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 applicable in the context of the provided document. The submission is for a medical device (microspheres), not an AI/ML diagnostic or prognostic tool that would typically use a test set of data. The "clinical evaluation" mentioned in Section 8 refers to a review of existing literature and post-market surveillance, not a specific prospective or retrospective study with a defined sample size for the purpose of validating an algorithm.
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 applicable. The document describes a medical device, not an AI/ML algorithm that requires expert-established ground truth on a test set. The clinical evaluation process relies on existing scientific literature, a broad assessment by medical professionals, and regulatory review processes, rather than a specific number of experts labeling data for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable for the same reasons as points 2 and 3.
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 applicable. This document is a 510(k) summary for a medical device (microspheres), not an AI/ML device, and thus no MRMC study or AI assistance evaluation was conducted or reported here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This document is a 510(k) summary for a medical device (microspheres), not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the purpose of this 510(k) submission, the "ground truth" concerning the safety and effectiveness of the Embozene® Microspheres (including the new sizes) is established through:
- Engineering and material characterization: In-vitro testing for size distribution and catheter compatibility (Section 7). This confirms the physical properties.
- Scientific literature review: A comprehensive review of Transarterial Embolization (TAE) using various embolic agents, including the existing Embozene® Microspheres, over the last ten years (Section 8). This constitutes a form of aggregated "outcomes data" and medical consensus from the broader scientific community.
- Unpublished data and post-market surveillance: This also contributes to the "outcomes data" and real-world evidence confirming the safety and effectiveness of the existing device family (Section 8).
There is no "ground truth" established for an AI algorithm's performance.
8. The sample size for the training set
This information is not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
This information is not applicable. This is not an AI/ML device.
§ 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).