(87 days)
STaK-Chex Plus Retics is intended to be used as a control for complete blood cell count (CBC), white cell five-part differential, and reticulocyte parameters on Beckman/Coulter GenS series hematology instruments.
STaK-Chex Plus Retics is a suspension of stabilized human red blood cells, human white cells, simulated human platelets, and simulated human reticulocytes packaged in glass vials containing 4.5 mL volumes. Closures are injection molded polypropylene screw-top caps. The vials are packaged in polystyrene jars.
The provided text describes a medical device called "STaK-Chex Plus Retics," an assayed hematology control. The 510(k) summary outlines its intended use and provides a brief discussion of test results.
Here's an analysis of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in a quantitative format (e.g., specific thresholds for accuracy, precision, sensitivity, specificity). Instead, it describes general findings from its studies.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Reproducibility | Consistently reproducible |
| Substantial Equivalence | Substantially equivalent to the predicate product |
| Stability | Stable for the entire product dating (Long Term Stability and Open Vial Stability) |
2. Sample size used for the test set and the data provenance
The document does not specify the sample size for any of the studies (I: Run to Run Reproducibility and Comparison to Whole Blood; II: Site to Site Reproducibility; III: Long Term Stability; IV: Open Vial Stability). It also does not mention the country of origin of the data or whether the studies were retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided. The device is a control for hematology instruments, implying that the "ground truth" would likely be derived from established laboratory protocols and instrument readings rather than expert consensus on patient cases.
4. Adjudication method for the test set
This information is not provided. Given the nature of a hematology control device, an adjudication method like 2+1 or 3+1 typically used for subjective image interpretation is not applicable. The "ground truth" for a control device is usually based on its known and verified values when used with calibrated instruments.
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
An MRMC study was not done. This device is a quality control product for laboratory instruments, not an AI-assisted diagnostic tool that involves human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This concept is not applicable to the described device. STaK-Chex Plus Retics is a physical control material used with hematology analyzers, not an algorithm.
7. The type of ground truth used
The ground truth for this type of device would be the expected and verified values of the control material (stabilized human red blood cells, human white cells, simulated platelets, and simulated human reticulocytes) when analyzed by properly calibrated Beckman/Coulter GenS series hematology instruments. This is established through rigorous internal testing and characterization of the control material itself, rather than expert consensus on individual cases, pathology, or outcomes data.
8. The sample size for the training set
This information is not applicable. The term "training set" typically refers to machine learning algorithms, which is not relevant for this device. The studies mentioned (Run to Run Reproducibility, Site to Site Reproducibility, Long Term Stability, Open Vial Stability) are performance validation studies, not training.
9. How the ground truth for the training set was established
This information is not applicable, as there is no "training set" in the context of this 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.