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Cell-Chex™ with CPPD Crystals is an assayed control intended for monitoring total cell counts performed manually using a hemocytometer to validate quantitation of red and white blood cells in patient cerebrospinal fluid and body fluid samples including pleural, pericardial, peritoneal and synovial fluid. Level 1 contains calcium pyrophosphate dihydrate (CPPD) Crystals which can be used to monitor the presence of crystals in synovial fluid.

Cell-Chex™ with CPPD Crystals is also intended for monitoring white blood cell differentiation (Mononuclear, Polymorphonuclear; Neutrophils, Eosinophils, Basophils, Lymphocytes and Monocytes) in body fluid samples performed using Cytospin® smears.

Cell-Chex™ with CPPD Crystals is a stabilized suspension of human red blood cells, human white blood cells and calcium pyrophosphate dihydrate (CPPD) Crystals (Level 1 only) in a preservative medium. The product is packaged in glass vials containing 2.0ml. The closures are polypropylene screw caps with polvethylene liners. There are two different levels. Level 1 contains a low cell count and CPPD crystals, and Level 2 contains a high cell count and no crystals. The vials will be packaged in a six (6) or twelve (12) welled vacuum formed clamshell container with the package insert / assay sheet. The product must be stored at 2 - 10°C.

The provided text describes the Cell-Chex™ with CPPD Crystals device, its intended use, and a comparison to a predicate device (Cell-Chex™). It also mentions the types of studies conducted to establish its performance. However, it does not explicitly state "acceptance criteria" in a quantitative format or report specific numerical performance metrics against those criteria. Instead, the studies aim to demonstrate reproducibility, substantial equivalence to the predicate, and stability.

Here's an analysis based on the provided text, addressing your points where possible:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not specify quantitative acceptance criteria. Instead, it frames the success of the studies in terms of "consistently reproducible," "substantially equivalent to the predicate product," and "stable for the shelf life claimed."

2. Sample Size Used for the Test Set and the Data Provenance

The document does not explicitly state the sample sizes used for the "Closed Vial Stability," "Open Vial Stability," "Run-to-Run Reproducibility," and "Precision Performance" studies. It also does not specify the data provenance (e.g., country of origin, retrospective or prospective).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

The document does not describe the use of experts or the establishment of ground truth in the context of clinical or diagnostic performance for the test set. The device is a "Hematology Quality Control Mixture," meaning its "ground truth" (i.e., its expected cell counts and crystal presence) is internally derived from its manufacturing specifications and assessed through analytical studies, rather than by expert interpretation of patient samples.

4. Adjudication Method for the Test Set

Not applicable. The "ground truth" for this control device is based on its composition and manufacturing specifications, not on expert adjudication of diagnostic images or clinical cases.

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 device is a hematology quality control mixture, not an AI or imaging device requiring human reader interpretation or assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a laboratory control, not an algorithm.

7. The Type of Ground Truth Used

The ground truth for this device is its manufactured composition and stability characteristics. For example, Level 1 contains CPPD crystals, and its expected cell counts (low count) are inherent to its design as a control. The studies focused on confirming that these inherent properties are maintained over time (stability) and are consistently met across manufacturing runs (reproducibility and precision).

8. The Sample Size for the Training Set

Not applicable. This is a physical control product, not an AI/machine learning model that requires a training set. The studies described are analytical validation studies.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for an AI/machine learning model. The "ground truth" for the control material itself is established through its formulation, manufacturing process, and characterization by the manufacturer.

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