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XN CHECK BF is used for control and calibration of Sysmex XN series (XN-10, XN-11, XN-20, XN-21, XN-L) analyzers. It is not, however, intended for actual calibration of these analyzers. Assayed parameters include:

WBC-BF (10^3/μL), RBC-BF (10^6/μL), MN# (10^3/μL), PMN# (10^3/μL), MN%, PMN%, TC-BF# (10^3/uL)

XN CHECK™ BF is an in-vitro diagnostic, two level, control. It contains the following: stabilized red blood cell component(s) and stabilized white blood cell component(s) in a preservative medium in polypropylene plastic vials with screw caps with a 3 mL fill. The vials will be packaged in (4) welled vacuum formed clamshell container with the Instructions for Use (IFU) / assay sheet. Product storage conditions are 2 - 8° C.

The provided document is a 510(k) premarket notification for a medical device called "XN CHECK BF." This device is a hematology quality control mixture, and the submission is for a new iteration of an already marketed product (K141957). The primary change in the new device is the addition of compatibility with the Sysmex XN-L analyzer.

The document does not contain the information requested regarding acceptance criteria for an AI/ML device, the study to prove it meets those criteria, sample sizes, expert involvement, or MRMC studies. This is because XN CHECK BF is a quality control material for laboratory analyzers, not an AI/ML diagnostic or image analysis device.

Therefore, I cannot extract the requested information from the provided text. The document focuses on performance testing relevant to a quality control material, such as precision and stability studies, which are different from the types of studies performed for AI/ML diagnostic tools.

To answer your request, I would need a document describing the regulatory submission for an AI/ML-driven medical device.

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