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The ABX MICROS 60 Hematology Analyzer is a fully automated (microprocessor controlled) hematology analyzer used for the in vitro diagnostic testing of whole blood specimens or blood cell concentrates. It operates in complete blood count (CBC) mode.

The ABX MICROS 60 device is a benchtop, clinical laboratory instruments that analyze in-vitro samples of whole blood specimens. The device operates in a complete blood count (CBC) and 3 part DIFF (LMG). As either a closed tube / closed system (CT/CS) or open tube/open system (OT/OS). The ABX MICROS 60 can evaluate 5,8, 16 or 18 hematology parameters depending on its internal configuration.

Here's a summary of the acceptance criteria and study information for the ABX MICROS 60 Hematology Analyzer based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily discusses that the device met acceptance criteria, but specific quantitative criteria for each parameter are not explicitly detailed in a separate table. Instead, general statements about meeting guidelines and correlations are provided.

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

• Sample Size for Test Set: Not explicitly stated. The document mentions "clinical data provided in this submission" and "clinical studies," but no specific sample size (number of patients or specimens) is given for the test set used to evaluate linearity and accuracy.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective).

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

• Number and Qualifications of Experts: Not mentioned. For a hematology analyzer, ground truth typically refers to reference methods performed by trained laboratory personnel or comparison to a predicate device. The document states "Accuracy (Inter-procedural Correlation) demonstrated no evidence of significant bias between the MICROS 60 and the Abbott CD 4000," implying the Abbott CD 4000 served as the reference/ground truth for accuracy assessment.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable or not described. This type of adjudication is more common in studies involving subjective interpretation (e.g., medical imaging reads). For an automated hematology analyzer, performance is typically assessed by comparing its quantitative results against a reference method.

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

• MRMC Study: No, an MRMC study was not done. This type of study would involve human readers interpreting cases with and without AI assistance, which is not relevant for an automated hematology analyzer like the ABX MICROS 60. The device performs automated analysis without human interpretation in the loop.

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

• Standalone Performance: Yes, the entire performance evaluation described is for the device in standalone mode. The ABX MICROS 60 is an "automated cell counter and automated differential cell counter" and a "fully automated (microprocessor controlled) multi-parameter hematology analyzer." The performance data presented (precision, linearity, accuracy) are for the device operating independently.

7. The Type of Ground Truth Used:

• Ground Truth Type:
  • For precision and linearity, the ground truth would typically be established by repeated measurements on stable samples and statistical analysis to ensure reproducibility and accurate measurement across concentration ranges.
  • For accuracy (inter-procedural correlation), the ground truth was established by comparison to a legally marketed predicate device, the ABBOTT CD 4000 (K961439).

8. The Sample Size for the Training Set:

• Training Set Sample Size: Not applicable or not stated. Hematology analyzers like the ABX MICROS 60 typically rely on established physical principles (e.g., impedance, optical scattering) and calibrated reagents rather than machine learning algorithms trained on a dataset. Therefore, the concept of a "training set" in the context of AI/ML is not directly relevant here. The device is "based on the same fundamental technology" as predicate devices.

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

• Training Set Ground Truth Establishment: Not applicable, as there isn't a "training set" in the AI/ML sense. The device's operation is based on established scientific principles rather than being trained on a dataset.

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