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Liquichek Hematology-16 Control LV is intended for use as an assayed hematology control to monitor the precision of hematology analyzers that measure the following parameters: GRAN (Granulocytes), HCT (Hematocrit), HGB (Hemoglobin), LYMPH (Lymphocytes), MCH (Mean Corpuscular Hemoglobin), MCHC (Mean Corpuscular Hemoglobin Concentration), MCV (Mean Corpuscular Volume), MID (Mid-Sized Cells), MONO (Monocytes), MPV (Mean Platelet Volume), PLT (Platelets), RBC Red Blood Cells), RDW (Red Blood Cell Distribution Width), WBC (White Blood Cells).

This product is a suspension of stabilized lysable human erythrocytes, simulated platelet components, simulated white cells and constituents of animal origin in a medium containing stabilizers and preservatives.

The provided text describes a medical device, the Bio-Rad Laboratories Liquichek Hematology-16 Control LV, and its submission for 510(k) premarket notification. The document focuses on establishing substantial equivalence to a predicate device and includes stability data.

Here's an analysis of the acceptance criteria and the study as requested:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device appear to be primarily related to its stability and performance as a quality control material, specifically its ability to maintain its assayed values over time. The document highlights two key stability claims:

Study Details:

1. Sample size used for the test set and the data provenance:
   The document states that "Stability studies have been performed to determine the open vial stability and shelf life for this control." However, it does not specify the exact sample size (number of vials, number of runs, etc.) used for these stability studies. The data provenance is internal, as it's from Bio-Rad Laboratories, and the studies were conducted to support the device's claims. It is a prospective study in the sense that the stability was tested for the duration of the claimed shelf life and open-vial stability.

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. For a hematology control, "ground truth" would likely refer to the assayed values of the analytes. These values are typically established through extensive testing on reference instruments, often by qualified laboratory personnel. The document does not detail this process or the qualifications of personnel involved in establishing these true values.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
   This information is not provided. Adjudication methods are typically relevant in studies involving subjective interpretation (e.g., image analysis by multiple readers). For a quantitative control like this, the "adjudication" would be through statistical analysis of the measured values over time against established reference ranges or by comparison to highly accurate reference methods. The document does not detail the statistical methods or how deviations were handled.

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 device is a hematology quality control material, not an AI or diagnostic imaging device that involves human readers. Therefore, the concept of human readers improving with AI assistance is not applicable here. The study focuses purely on the stability and performance of the control material itself.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
   Not applicable in the context of an algorithm. This device is a physical control material. However, the stability studies effectively represent a "standalone" assessment of the control material's stability without human intervention affecting its core stability properties. The performance monitored is the stability of the analytes within the control.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   For a hematology control, the "ground truth" for the analyte values would be the assigned assayed values determined by Bio-Rad Laboratories during the manufacturing and characterization process, likely using established reference methods and calibrated instruments. This is typically analogous to a "reference standard" or "master value" rather than expert consensus, pathology, or outcomes data. The document does not explicitly state the methodology for establishing these initial assayed values.

7. The sample size for the training set:
   This device is a quality control material and does not involve AI or machine learning, therefore, there is no training set in the conventional sense of developing an algorithm. The "training" for such a product would be the formulation and manufacturing process development.

8. How the ground truth for the training set was established:
   As there is no training set for an AI algorithm, this question is not applicable.

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