(296 days)
XN-L CHECK is used for control and calibration verification of Sysmex XN-L analyzers. It is not, however, intended for actual calibration of this analyzer. Assayed parameters include:
RBC (10^6/uL), HGB (g/dL), HCT (%), MCV (fL), MCH (pg), MCHC (g/dL), PLT (10^3/uL), RDW-SD (fL), RDW-CV (%), MPV (fL), WBC (10^3/uL), NEUT (%), LYMPH (%), MONO (%), EO (%), BASO (%), IG (%), NEUT# (10^3/uL), LYMPH# (10^3/μL), MONO# (10^3/μL), EO# (10^3/μL), BASO# (10^3/μL), IG# (10^3/μL), RET# (10^6/uL), RET%, IRF%, RET-He (pg).
XN-L CHECK™ is an in-vitro diagnostic, three level (Levels 1, 2, and 3) hematology product that contains the following stabilized red blood cell component(s), stabilized white blood cell component(s) in a preservative medium. The product is packaged in polypropylene plastic vias with screw caps with a 3 ml fill. The vials will be pacum formed clamshell container with the Instructions for Use (FU) / assay sheet. Product storage conditions are 2 - 8° C.
The provided document is a 510(k) premarket notification for a medical device called "XN-L CHECK™", a hematology quality control mixture. It describes the device, its intended use, and compares it to a predicate device. However, it does not contain specific acceptance criteria, study details, or results in the format requested.
The document broadly states:
- "The resultant data set established that XN-L CHECK is safe and effective for its intended use and that the product is stable for the entire product dating."
- "Study results show XN-L CHECK to be consistently reproducible, substantially equivalent to the predicate products, and stable for the entire product dating."
It mentions the following types of studies were conducted:
- Multi-Site Precision Study
- Single-Site Precision Study
- Open-Vial Stability
- Closed-Vial Stability
However, it does not provide any quantitative acceptance criteria or the reported device performance measurements for these studies. Therefore, I cannot generate the requested table or answer most of the specific questions about sample sizes, ground truth, expert involvement, or MRMC studies.
Based on the information available, here's what can be inferred or explicitly stated:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document states that performance data was collected and the device was found safe, effective, and stable, but it does not specify the numerical acceptance criteria (e.g., specific thresholds for precision or stability over time) or the actual reported performance values.
2. Sample size used for the test set and the data provenance
- Cannot be provided. The document mentions "Multi-Site Precision Study, Single-Site Precision Study, Open-Vial Stability and Closed-Vial Stability" but does not specify the sample sizes (number of samples, runs, instruments, or sites) used for these studies, nor the provenance (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable / Cannot be provided. This device is a quality control mixture and not an interpretive AI device that would require expert adjudication for a diagnostic ground truth. The "ground truth" for a quality control device typically involves reference methods or established performance specifications of the analyzer it controls. The document does not mention any experts in the context of establishing ground truth for testing.
4. Adjudication method for the test set
- Not applicable / Cannot be provided. As explained in point 3, this is a quality control material, not a diagnostic device requiring expert interpretation and adjudication of results for a reference standard.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. This device is a hematology quality control mixture, not an AI-assisted diagnostic tool, so an MRMC study is not relevant or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable / Cannot be provided. This is not an algorithm or AI device. It's a physical control material used to assess the performance of a hematology analyzer.
7. The type of ground truth used
- Inferred: For a quality control mixture, the "ground truth" or reference values are typically established through extensive testing against highly accurate reference methods or by comparison to another established quality control material (the predicate device in this case) on the target analyzer. The document doesn't explicitly state the "type of ground truth" but implies it involves demonstrating "consistent reproducibility" and "substantial equivalence to the predicate products."
8. The sample size for the training set
- Not applicable / Cannot be provided. This is not an AI/machine learning device, so there is no concept of a "training set."
9. How the ground truth for the training set was established
- Not applicable / Cannot be provided. As explained in point 8, there's no training set for this type of 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.