(297 days)
The Bella-mu is indicated for intradermal injections of FDA approved drugs for patients 18 years of age and older. The Bella-mu is to be inserted in the dermis of the suprascapular, deltoid, waist, or thigh regions.
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I am sorry, but the provided text from the FDA 510(k) clearance letter for the "Bella-mu" device does not contain information about acceptance criteria or the study that proves the device meets the acceptance criteria in the way you have described for an AI/ML medical device.
This document is a standard FDA 510(k) clearance letter, which typically confirms that a device is substantially equivalent to a predicate device and can be legally marketed. It focuses on regulatory aspects like product codes, regulations, general controls, and good manufacturing practices.
For a device like "Bella-mu" which is described as a "Hypodermic Single Lumen Needle" for "intradermal injections," the types of studies performed (e.g., biocompatibility, sterility, needle pull-off force, flow rates, sharpness, patient comfort, etc.) and their acceptance criteria are generally found in the full 510(k) submission, which is not publicly released in its entirety in this clearance letter.
Therefore, I cannot provide the detailed information requested in your prompt based on the provided text. The prompt's questions (e.g., number of experts, MRMC studies, standalone performance, training/test set sample sizes, ground truth establishment) are highly relevant for AI/ML device submissions, but not applicable to the information contained within this specific 510(k) clearance letter for a medical needle.
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).