(34 days)
The Okami Medical LOBO Vascular Occlusion System is intended for use to obstruct or reduce the rate of blood flow in arteries of the peripheral vasculature. The device is not indicated for use in blood vessels where crush or bend forces are anticipated (e.g. joint areas, superficial vasculature).
Not Found
I am sorry, but the provided text from the FDA letter does not contain the information required to answer the questions about the acceptance criteria and the study that proves the device meets those criteria. The letter is a 510(k) clearance letter for the "LOBO Vascular Occlusion System," which is a vascular embolization device. This type of device is a physical medical device, not an AI/software device that would typically undergo the kind of performance studies described in your request (e.g., studies involving AI algorithms, expert readers, ground truth establishment, MRMC studies, etc.).
The letter confirms that the device is "substantially equivalent" to legally marketed predicate devices and outlines the regulatory basis for its marketing, general controls, and other administrative requirements. It provides the device name, regulation number, regulation name, regulatory class, product code, and indications for use.
Therefore, I cannot populate the table or answer the specific questions about AI/software performance studies, sample sizes, expert qualifications, or ground truth methodologies based on the provided document.
§ 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).