(57 days)
CD-Chex Plus BC is designed to serve as a quality control specimen for clinical flow-cytometric procedures performed with Beckman Coulter® flow cytometry instruments.
CD-Chex Plus BC is a suspension of stabilized human red blood cells and human white blood cells packaged in a plastic vial containing 3.0 mL volumes. The vials are packaged in a vacuum formed "clam-shell" box.
The provided text describes a 510(k) premarket notification for a medical device called CD-Chex® Plus BC, which is an immunophenotyping control. The information focuses on demonstrating its substantial equivalence to a predicate device, CD-Chex® Plus, and its stability and reproducibility.
However, the submission does not contain the kind of detailed information requested regarding acceptance criteria, specific performance metrics, sample sizes for test and training sets, expert qualifications, or ground truth establishment relevant to an AI/ML medical device. This is because CD-Chex® Plus BC is a quality control specimen, not an AI/ML algorithm. The "device performance" in this context refers to its stability and reproducibility as a control material, not the diagnostic performance of an AI system.
Therefore, many of the requested fields cannot be directly populated from the provided text as they are designed for evaluating AI/ML-based diagnostic devices.
Here's an attempt to answer the questions based on the available information, noting where the information is not applicable or not provided for this type of device:
1. A table of acceptance criteria and the reported device performance
For a quality control specimen like CD-Chex® Plus BC, "acceptance criteria" and "device performance" relate to its ability to remain stable and reproducible over time and across different sites. Specific quantifiable criteria (e.g., allowable ranges for cell counts or antigen expression) are not detailed in this summary but would typically be established by the manufacturer and validated through the studies mentioned.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Closed Vial Stability (maintain specified characteristics) | Consistently reproducible and stable for 60 days |
| Open Vial Stability (maintain specified characteristics after opening) | Consistently reproducible and stable for the entire product dating (specific duration not in summary) |
| Reproducibility Across Sites (consistent results at different locations) | Consistently reproducible across sites |
| Substantial Equivalence to Predicate Device (CD-Chex® Plus) | Determined to be substantially equivalent |
2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: Not explicitly stated. The studies involved testing the product over time and at alternate sites, implying multiple samples of the CD-Chex® Plus BC product itself were used.
- Data Provenance: Not specified. The studies were likely conducted by the manufacturer (Streck) and potentially collaborating sites (Alternate Site Testing). It's reasonable to assume the studies were prospective, as they involved monitoring the product's stability and performance over time.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This concept is not directly applicable to a quality control specimen. The "ground truth" for CD-Chex® Plus BC would be its inherent specifications and expected values (e.g., target ranges for cell populations or fluorescence intensities), which are established through the manufacturing process and extensive characterization/validation by the manufacturer's R&D and QA teams. This doesn't involve "experts" in the context of diagnostic interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert interpretations of diagnostic data, which is not relevant for a quality control product.
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
Not applicable. MRMC studies are for evaluating the impact of an AI system on human diagnosticians. CD-Chex® Plus BC is a quality control material for flow cytometry instruments, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. CD-Chex® Plus BC is not an algorithm. Its performance is evaluated intrinsically as a biological control material.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
As explained in point 3, the "ground truth" for a quality control material is its established specifications and expected performance characteristics, determined by the manufacturer's internal validation processes and scientific principles of cellular stability. It's not based on expert consensus, pathology, or outcomes data in the diagnostic sense.
8. The sample size for the training set
Not applicable. As a quality control specimen, CD-Chex® Plus BC does not have a "training set" in the context of machine learning. The studies listed (Closed Vial Stability, Open Vial Stability, Alternate Site Testing) are validation studies of the manufactured product.
9. How the ground truth for the training set was established
Not applicable. There is no "training set" and associated "ground truth" in the AI/ML sense for this product. The "truth" about the product's functionality (stability and reproducibility) is established through the experimental results of the "Testing Performed" section.
§ 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.