(191 days)
Easi-Vue™ embolic microspheres System is intended for embolization of arteriovenous malformations and hypervasular tumors.
Easi-Vue embolic microspheres are biocompatible, radiopaque, non-compressible, non-resorbable glass microspheres. The Easi-Vue embolic microspheres are included with the Easi-Vue embolic microspheres System which is comprised of Easi-Vue embolic microspheres Administration Kit and the Easi-Vue embolic microspheres Refill Syringe. The device utilizes the Administration Kit for controlled and targeted delivery of imageable radiopaque microspheres. The Easi-Vue™ embolic microspheres System is offered in three sizes: 50 um, and 150 um to occlude various size arteries for the purpose of blocking blood flow to a target tissue (as summarized in Table 1).
The Easi-Vue™ embolic microsphere System is sterile, single use, and available only for prescription use. The device is compatible with a catheter with minimum inner diameter of 0.021'' and a length between 110-150 cm (as appropriate for the diameter of the intended treatment vessel).
The provided text describes a medical device, the Easi-Vue™ embolic microspheres System, seeking 510(k) clearance based on substantial equivalence to a predicate device. The information provided focuses on the characteristics of the device itself and its comparison to a predicate, rather than an AI-driven diagnostic system that would typically have acceptance criteria focused on algorithm performance metrics (e.g., sensitivity, specificity, AUC) and a test set of patient data with ground truth.
Therefore, many of the requested points regarding acceptance criteria, study design, and performance metrics for an AI system are not directly applicable or derivable from the provided document.
However, I can extract information related to the device's performance based on the non-clinical performance summary.
Here's an attempt to answer the questions based on the available information, noting where information is not present or relevant to AI systems:
1. A table of acceptance criteria and the reported device performance
Since this is a non-AI device, the acceptance criteria are not typically presented as performance metrics like sensitivity/specificity but rather as successful completion of various tests.
| Acceptance Criteria (from "Non-Clinical Performance Summary") | Reported Device Performance |
|---|---|
| Biocompatibility according to ISO 10993 | Demonstrated to be biocompatible |
| Meet all acceptance criteria for bench testing (including simulated use, MR compatibility, and performance verification) | Met all acceptance criteria and performed as intended |
| Ease of delivery (in animal study) | Confirmed |
| Effectiveness of arterial occlusion (in animal study) | Confirmed |
| No clinically significant pathological abnormalities (in animal study) | Confirmed |
| No systemic abnormalities (in animal study) | Confirmed |
| No new safety or effectiveness concerns raised during testing | Confirmed |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: This information is not explicitly provided in terms of "test set" for an AI system. The document mentions a GLP animal study. The number of animals used in this study is not specified.
- Data Provenance: The GLP animal study is a prospective study. The country of origin for the animal study data is not specified in the provided text.
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 is not applicable as the study described is an animal study for a physical medical device, not an AI system being evaluated against human expert labeling of data. The "ground truth" was established through direct observation and pathological assessment in the animal study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for a non-AI device animal study. Adjudication methods are typically used for expert labeling of data in AI model evaluation.
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. This is not an AI-assisted device, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable as this is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the animal study, the ground truth was established through:
- Direct observation of "ease of delivery" and "effectiveness of arterial occlusion."
- Pathological assessment to confirm "no clinically significant pathological abnormalities or systemic abnormalities."
8. The sample size for the training set
Not applicable as this is a physical medical device, not an AI system that requires a training set.
9. How the ground truth for the training set was established
Not applicable as this is a physical medical device, not an AI system.
§ 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).