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R&D CBC-4K Plus Retics Hematology Control is an assayed whole blood control designed to monitoring the accuracy and precision of CELL-DYN® hematology instruments. Refer to assay sheet for specific instrument models.

This control is an assayed whole blood control designed to monitor values on multi-parameter hematology cell counters.

Here's an analysis of the provided text regarding the R&D CBC-4K Plus Retics Hematology Control, focusing on acceptance criteria and the supporting study:

Acceptance Criteria and Device Performance

Note: The document describes the "life of the product" as 75 days (closed vial) and 8 days (open vial) when stored at 2-8°C.

Study Details

1. Sample size used for the test set and the data provenance:

   • Sample Size: "3 validation lots" were used for laboratory testing. The exact number of individual samples within these lots is not specified.
   • Data Provenance: The data appears to be prospective as it's generated from "laboratory testing" and validation of new lots of the control product. The country of origin is implicitly the United States, as R&D Systems, Inc. is based in Minneapolis, MN, and the submission is to the FDA.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This information is not provided in the document. The "ground truth" for a hematology control would typically be its manufacturing-assigned values and expected stability based on formulation and empirical testing. It's not a diagnostic device that requires expert interpretation of results for ground truth.

3. Adjudication method for the test set:

   • This is not applicable as the device is a quality control material, not a diagnostic device requiring human interpretation and multi-reader adjudication. The performance is assessed against predefined assay ranges and statistical metrics (standard deviation, %CV).

4. 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, an MRMC comparative effectiveness study was not done. This type of study is relevant to diagnostic interpretation by human readers, often with AI assistance, which is not the purpose of a hematology control material.

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

   • The concept of "standalone performance" for this device is not applicable in the typical sense of an AI algorithm. The device is the control material itself, and its performance is evaluated instrumentally (on CELL-DYN® hematology instruments) against established criteria and compared to a predicate device. The "algorithm" here is the underlying chemical and biological formulation of the control and its interaction with the specified instruments. The testing described is its standalone performance without human interpretation of its results, though human users would use the results to monitor instruments.

6. The type of ground truth used:

   • The "ground truth" for a quality control material is typically its manufacturing-assigned target values and expected range, along with its stability profile over time under specified storage conditions. The study confirms that the material remains within these predefined assay ranges and demonstrates consistent precision.

7. The sample size for the training set:

   • This information is not provided. For a physical control material like this, there isn't a "training set" in the machine learning sense. The formulation and initial performance characteristics would be established through a developmental phase, which is not detailed here. The "laboratory testing" described seems to be the validation of the final product.

8. How the ground truth for the training set was established:

   • As noted above, the concept of a "training set ground truth" isn't directly applicable. The "ground truth" for the control material itself would be established during its development and manufacturing process, likely through:
     • Formulation science: Developing the chemical and biological composition to achieve desired cell counts and parameters.
     • Reference methods: Assaying the control lots using highly accurate and precise reference methods or instruments to assign initial target values.
     • Stability studies: Conducting real-time and accelerated stability studies to determine expiration dates and storage conditions.
     • Predicate device comparison: Using the performance of the predicate device as a benchmark.

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