(168 days)
UniPearls® Embolic Microspheres are indicated for embolization of hypervascularized tumors including hepatoma, and peripheral arteriovenous malformations.
UniPearls® Embolic Microspheres consist of non-biodegradable hydrogel microspheres packaged in a 10 ml penicillin bottle. The penicilin bottle contains 1 ml of spheres suspended in 7 ml of physiological saline or 2 ml of spheres suspended in 6 ml of physiological saline. UniPearls® Embolic Microspheres are offered in seven sizes: 70μm, 400μm, 500μm, 700μm and 1000μm. The spheres are available in two colors: colorless and blue. The spheres are intended to be used with an inner diameter that is adequate for sphere delivery (not included). The finished by steam and is intended for single use only.
I am sorry, but the provided text does not contain the detailed information necessary to fully answer your request. The document is an FDA 510(k) clearance letter and a 510(k) summary for a medical device called "UniPearls® Embolic Microspheres." While it mentions that performance testing was conducted and met pre-determined acceptance criteria, it does not provide the specific acceptance criteria themselves, nor does it describe the details of the study that proves the device meets these criteria in the way you have requested.
Specifically, the following information is missing from the provided text:
- A table of specific acceptance criteria and reported device performance. The document only generally states that criteria were met.
- Sample size used for the test set and data provenance.
- Number of experts used to establish ground truth and their qualifications.
- Adjudication method.
- Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, the effect size.
- Whether a standalone performance study was done.
- The type of ground truth used (expert consensus, pathology, outcome data, etc.).
- The sample size for the training set.
- How the ground truth for the training set was established.
The document does list some of the types of non-clinical tests performed, such as "Appearance and Size Range, Catheter Deliverability, Compressibility Test, Water Content, Quantity Test, pH Test, Impurities and Residual Solvent, Bacterial Endotoxin, Sterility Test, Sample Size Calculation; animal study, etc." However, it does not give the specific numerical or qualitative acceptance criteria for these tests, nor the results achieved.
§ 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).