Search Results

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.

Not Found

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.

Ask a specific question about this device