(86 days)
Contour SE™ Microspheres may be used for the embolization of hypervascular tumors, including leiomyoma uteri, and arteriovenous malformations (AVMs).
Contour SET™ Microspheres may be used for the embolization of hypervascular tumors, including leiomyoma uteri, and arteriovenous malformations (AVMs).
The provided text is a summary of safety and effectiveness for a medical device (Contour SET™ Microspheres) and a letter from the FDA regarding its 510(k) premarket notification. This document outlines the general provisions, intended use, and substantial equivalence to predicate devices for the Contour SET™ Microspheres.
However, the document does not contain information about acceptance criteria, specific device performance metrics, detailed study designs (sample sizes for test/training sets, data provenance, expert qualifications for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance), or the type of ground truth used, in the context that would be expected for a typical AI/ML device study.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and study details as requested. The document focuses on regulatory approval based on substantial equivalence to existing devices and biocompatibility, not on a performance study against predefined acceptance criteria for a new AI/ML-driven device.
No information is available in the provided text to fulfill the request for a table of acceptance criteria and reported device performance, or the detailed study information regarding sample sizes, ground truth establishment, expert qualifications, or MRMC studies.
§ 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).