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CD-Chex PLUS is intended to be used as a control for evaluating monoclonal antibody binding by flow cytometry. CD-Chex PLUS control cells possess surface antigens detectable with monoclonal antibodies. When these cells are stained with fluorescent antibodies and analyzed by flow cytometry they provide a reference for normal peripheral blood leukocytes. CD-Chex PLUS is designed for use on Becton Dickinson and Coulter flow cytometry systems

CD-Chex PLUS is a suspension of stablized human red blood cells and human white cells packaged in glass vials containing 2.5 or 4.0 mL volumes. Closures are polypropylene screw-top caps. The vials are packaged in polystyrene jars.

The provided 510(k) summary for K960894 (CD-Chex PLUS) does not contain sufficient detail to complete all sections of the request. This device is an immunophenotyping control, not an AI/ML powered device, therefore many of the requested categories (e.g., sample size for test set, expert qualifications, MRMC, training set details) are not applicable or not provided in the context of typical AI/ML device studies.

However, based on the available information, here's what can be extracted and inferred:

1. A table of acceptance criteria and the reported device performance

The document speaks generally about "reproducibility" and "stability" as key performance indicators without specifying numerical acceptance criteria for each. The stated device performance is that it met these unspecified criteria.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "Four studies" were conducted but does not specify the sample sizes (e.g., number of lots, number of vials, number of sites) for each study. The data provenance is not specified beyond being generated by "Streck Laboratories, Inc."

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)

Not applicable. This device is a control material, not a diagnostic device that requires expert interpretation for ground truth establishment. Its performance is evaluated based on its own inherent stability and reproducibility properties when analyzed by flow cytometry systems.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as ground truth by expert consensus is not relevant for this type of device.

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. This is not an AI-powered device, and no human reader effectiveness study would be performed for a laboratory control.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithm-based device. Its performance is evaluated through laboratory studies on its physical characteristics and behavior in flow cytometry systems.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The concept of "ground truth" as typically defined for diagnostic or AI devices (e.g., pathology, clinical outcome) is not directly applicable here. For a control material like CD-Chex PLUS, the "truth" is established by its intrinsic and consistent characteristics (antigen expression, cell count, viability) when measured by a flow cytometer, and its ability to provide a predictable reference. The performance is assessed against expected values or by comparison to a predicate device, rather than against an independent clinical "ground truth."

8. The sample size for the training set

Not applicable. This device is a control material, not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable. This device is a control material, not an AI/ML algorithm that requires a training set.

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