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The DREW D3 Hematology Analyzer is a fully automated (microprocessor controlled) quantitative hematology analyzer used for the in vitro diagnostic testing of whole blood specimens.

The D3 Hematology Analyzer is a stand-alone benchtop, clinical laboratory instrument which analyzes in-vitro samples of whole blood to provide complete blood count and leucocyte differential count using the impedance & spectrophotometry techniques.

The D3 Hematology Analyzer is a stand-alone benchtop clinical laboratory instrument that analyzes in-vitro samples of whole blood to provide complete blood count and leukocyte differential count using impedance and spectrophotometry techniques.

The following information regarding the acceptance criteria and the study proving the device meets these criteria is extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document doesn't explicitly list a table of "acceptance criteria" with quantitative values. Instead, it states that "Accuracy, Repeatability, Linearity, Carryover, Sample Stability studies demonstrated acceptable performance per the manufacturers specifications." It also highlights substantial equivalence to the predicate device, DATACELL 18MS (K945678). The key performance aspect is that the device "meets all acceptance criteria and demonstrating that the devices are substantially equivalent to the predicate device."

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

The document does not explicitly state the specific sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the data). It only mentions "The non-clinical studies and data analysis were carried out in accordance with appropriate indications given by the FDA guidelines."

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

This information is not provided in the document.

4. Adjudication Method for the Test Set

The document does not mention any adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study, nor any effect size regarding human reader improvement with or without AI assistance. The device is a "D3 Hematology Analyzer," suggesting an automated instrument rather than an AI-assisted diagnostic tool for human readers.

6. Standalone (Algorithm Only) Performance

The D3 Hematology Analyzer is described as a "fully automated (microprocessor controlled) quantitative hematology analyzer." This indicates that its performance is standalone (algorithm only) without human-in-the-loop directly influencing the output measurements. The performance studies listed (Accuracy, Repeatability, Linearity, Carryover, Sample Stability) describe the standalone performance of the device.

7. Type of Ground Truth Used

The type of ground truth used is not explicitly stated in the document. For hematology analyzers, ground truth is typically established through reference methods, manual microscopic differentials performed by trained technologists/pathologists, or validated control materials. However, the document does not specify which of these was used.

8. Sample Size for the Training Set

The document does not specify a separate training set or its sample size. Given that the device is a hematology analyzer, and the phrase "training set" is usually associated with AI/machine learning models, it's possible that traditional calibration and validation methods were used rather than an AI-specific training set.

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

As no training set is explicitly mentioned, the method for establishing its ground truth is also not detailed.

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