(296 days)
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.
§ 864.8625 Hematology quality control mixture.
(a)
Identification. A hematology quality control mixture is a device used to ascertain the accuracy and precision of manual, semiautomated, and automated determinations of cell parameters such as white cell count (WBC), red cell count (RBC), platelet count (PLT), hemoglobin, hematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), and mean corpuscular hemoglobin concentration (MCHC).(b)
Classification. Class II (special controls). Except when intended for use in blood components, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.