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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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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 Hematology Analyzer is a bench top clinical laboratory instrument which analyzes in vitro samples of whole blood to provide complete blood count data using principles of cytochemistry, focused flow impedance, and light transmission technology. The system is equipped with automatic calibration; Automated smart cards based for: calibration, QC with 93 multiple range files and memory with 60 erasable results.

Here's an analysis of the provided text regarding the acceptance criteria and study for the ABX MICROS 60 Hematology Analyzer:

Due to the nature of the provided document (a 510(k) summary for a legacy device from 2001), some of the requested information (especially regarding modern AI/ML study practices like multi-reader multi-case studies, detailed ground truth establishment for training, or specific acceptance criteria tables with numerical thresholds) is not explicitly present in the document. The document focuses on demonstrating substantial equivalence to a predicate device and broadly describing performance, rather than detailing a rigorous, pre-defined acceptance criteria study in the way a modern AI/ML device would.

However, I will extract and present all available information and highlight what is missing based on your request.

Acceptance Criteria and Device Performance Study for ABX MICROS 60 Hematology Analyzer

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in a table format. Instead, it describes performance characteristics and concludes that they are "acceptable" or "highly correlated." The predicate device comparison implies that the ABX MICROS 60 performance should be at least comparable to the BAKER SYSTEM 9110* PLUS.

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

The document does not specify the sample size used for the test set. It mentions testing a "high level control 10 times in succession on a single day" for precision, but this is not the full test set.

The data provenance is also not explicitly stated. It can be inferred that the testing was conducted prospectively as part of the device development and submission process. The country of origin of the data is not mentioned, but given the company's US address (Irvine, CA), it is likely to be from the USA.

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. For a hematology analyzer measuring objective parameters like cell counts, the "ground truth" would typically be established by established reference methods, manual microscopy by trained laboratory personnel, or internal laboratory standards and controls, rather than a panel of "experts" in the context of image interpretation.

4. Adjudication Method for the Test Set

This information is not applicable/provided. Adjudication methods (like 2+1, 3+1) are typically used for subjective assessments (e.g., image interpretation by multiple readers) to establish a consensus ground truth. For an automated hematology analyzer measuring numerical parameters, the "ground truth" would likely come from an objective reference method or a reference instrument, not through human adjudication of differing interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study (comparing human readers with and without AI assistance) is relevant for AI/ML devices where the algorithm interacts with human interpretation. The ABX MICROS 60 is a standalone automated analyzer, not an AI-assisted diagnostic tool.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the study described is a standalone performance study. The ABX MICROS 60 Hematology Analyzer is an automated device designed to measure parameters directly. The performance data presented (precision, linearity, correlation, carry-over) reflects the direct output of the instrument without human intervention in the primary measurement process itself.

7. The Type of Ground Truth Used

The ground truth for this device would have been established through a combination of:

• Reference Methods: Comparison to established standard laboratory methods for cell counting. While not explicitly stated, this is standard practice.
• Predicate Device Comparison: The study explicitly mentions correlation with the BAKER SYSTEM 9110+ PLUS, which serves as a type of "ground truth" or reference for establishing substantial equivalence.
• Calibrators and Controls: Mention of "high level control" indicates the use of known reference materials.

Pathology reports or outcomes data are generally not the direct ground truth for individual numerical cell counts from a hematology analyzer, although clinical outcomes can validate the utility of the parameters measured. Expert consensus is also less direct for objective numeric measurements, compared to subjective interpretations.

8. The Sample Size for the Training Set

The document does not mention a "training set". This term is primarily associated with machine learning or artificial intelligence devices that are trained on data. The ABX MICROS 60, being a 2001 device, is a classical, rule-based or impedance-based instrument, not an AI/ML device that undergoes a training phase in the modern sense. Its development would have involved extensive calibration and internal validation rather than training on a separate dataset.

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

As there is no mention of a "training set" in the context of an AI/ML device, this question is not applicable to the information provided. The "ground truth" for the development and calibration of such a device would have been established through traditional laboratory methods, reference instruments, and certified control materials during its engineering and validation phases.

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