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QBC Centrifugal Hematology Control is intended as a quality control for QBC+, QBC II, QBC II Plus, QBC Reference and QBC AUTOREAD centrifugal hematology systems, to monitor hematocrit, hemoglobin, white blood cell count, granulocyte count, lymphocyte/monocyte count, and platelet count.

The product is an in vitro diagnostic reagent composed of mammalian erythrocytes, mammalian leukocytes and simulated platelets in a plasma-like fluid with preservatives. OBC Control is composed of stable materials that provide a means of monitoring the performance of QBC centrifugal hematology systems. Overall system performance of disposable OBC blood tubes, including tube coating and float, is also monitored. QBC control is available in two levels that have varying concentrations of the parameters measured. QBC Control is used and tested in the same manner as patient samples.

The provided text is a 510(k) Summary for the QBC® Centrifugal Hematology Control device. It describes the device, its intended use, and a nonclinical study conducted to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: The text states "Nonclinical testing of 3 validation lots centered on the performance attributes of stability and precision." While the number of "lots" is provided, the specific number of individual samples or measurements within those lots is not specified.
• Data Provenance: The text does not explicitly state the country of origin of the data. It is a nonclinical study conducted by R&D Systems, Inc. in Minneapolis, MN, USA. The study design is implied to be prospective as it's a validation study for a new product, though not explicitly stated.

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

• Not Applicable. This was a nonclinical performance study of a quality control material, not a study involving human interpretation of clinical data in comparison to expert ground truth. The "ground truth" for a quality control material would be its expected range of values for each parameter, which is typically established by the manufacturer through rigorous testing and characterization.

4. Adjudication Method for the Test Set:

• Not Applicable. As noted above, this was a nonclinical performance study. No human adjudication of results was required as the evaluation was against pre-defined performance specifications (stability, precision).

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

• No. An MRMC study is not relevant for this type of device (a hematology control). This device is an in vitro diagnostic reagent used to monitor the performance of hematology analyzers, not to be interpreted by human readers.

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

• Yes, in essence. The entire nonclinical study described is effectively a "standalone" performance evaluation of the quality control material itself when used with the intended hematology systems. There is no "human-in-the-loop" component to the performance of the control material, only human operation of the analyzer and interpretation of the analyzer's output in relation to the control's established ranges.

7. The Type of Ground Truth Used:

• For stability and precision, the "ground truth" is typically the manufacturer-established assay range and statistical performance targets for the control material. These targets are derived from extensive characterization of the product's components and expected performance over time and under various conditions. The text mentions "remaining within the assay range" and "small standard deviations and %CVs," indicating these pre-defined targets as the ground truth.

8. The Sample Size for the Training Set:

• Not applicable/Not specified. This device is a quality control material, not an AI/ML algorithm that requires a "training set" in the conventional sense. The "training" for such a product involves its initial formulation, characterization, and the establishment of its expected performance characteristics. The 3 validation lots are for testing, not training.

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

• Not applicable. As above, there's no "training set" in the AI/ML context. The expected performance characteristics (the "ground truth" for a QC material) are established by the manufacturer through their R&D processes, including formulation, optimization, and extensive testing during product development to define its intended assay ranges, stability, and precision.

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