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CBC-5D™ is a tri-level hematology control designed to document and monitor values obtained from Coulter® hematology instruments.

CBC-5D™ is an in vitro diagnostic reagent composed of human erythrocytes, simulated leukocytes and platelets suspended in a plasma-like fluid with preservatives. It is composed of stable materials that provide a means of verifying accuracy and precision of Coulter® Hematology Systems. CBC-5D™ is available in three levels of measured constituents and is run in the same manner as patient specimens.

Here's an analysis of the provided text regarding the acceptance criteria and study for the CBC-5D™ Hematology Control:

The provided document describes the 510(k) submission for the CBC-5D™ Hematology Control. It focuses on demonstrating substantial equivalence to a predicate device (CBC-STK™) primarily through performance data related to stability.

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The document doesn't explicitly state numerical "Expected Ranges" or specific recovery percentages that defined the acceptance. It only states that the results "met acceptance criteria for stability tested by recovery of values within the Expected Range."

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

The document does not specify the sample size for the test set used to determine the stability.
The data provenance is not explicitly stated (e.g., country of origin, retrospective/prospective). It can be inferred that the studies were likely conducted internally by R&D Systems, Inc. given the context of a 510(k) submission and the company's role.

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

This information is not provided in the document. For a hematology control, "ground truth" typically refers to the expected target values or ranges derived from well-controlled analytical methods or established reference materials, rather than expert consensus on subjective interpretations.

4. Adjudication Method for the Test Set:

This information is not applicable and therefore not provided for this type of device (a hematology control). Adjudication methods like 2+1 or 3+1 are typically used for studies involving human interpretation of diagnostic images or clinical data where consensus among experts is needed. For a control material, performance is measured against established analytical targets.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, a MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic tools where human readers’ performance (e.g., accuracy, efficiency) with and without AI assistance is compared. The CBC-5D™ is a quality control material, not a diagnostic tool requiring human interpretation or AI assistance.

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

No, a standalone algorithm-only performance study was not done. This device is a biochemical control material, not a software algorithm. Its performance is evaluated by its stability and ability to yield consistent results when run on hematology instruments, not by an algorithm's output.

7. The Type of Ground Truth Used:

The ground truth for this device's performance evaluation (stability) would be based on established reference ranges or expected values for the measured hematology parameters (e.g., red blood cell count, white blood cell count, platelet count). These expected ranges would be determined through rigorous analytical testing using reference methods and/or comparison to established control materials. The document states "recovery of values within the Expected Range," implying such a ground truth.

8. The Sample Size for the Training Set:

This information is not applicable and therefore not provided. This device is a quality control material and does not involve machine learning algorithms that require a "training set."

9. How the Ground Truth for the Training Set was Established:

This information is not applicable and therefore not provided, as there is no "training set" for this device.

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