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The VEGA RETIC Automated Hematology Analyzer is an automated hematology analyzer providing complete blood count (CBC), differential leucocyte count (DIFF) as well as reticulocyte count for in vitro diagnostic use in clinical laboratories. The VEGA RETIC Automated Hematology Analyzer provides appropriate flags and alarms to assist users in final checking and identification of abnormal cell populations.

The VEGA RETIC Automated Hematology Analyzer is a benchtop, clinical laboratory instrument which analyzes in-vitro samples of whole blood to provide complete blood count, leucocyte differential count and reticulocyte count using principles of cytochemistry, focused flow impedance, light scattering, and fluorescence. The instrument is microprocessor driven.

The provided text describes the VEGA RETIC Automated Hematology Analyzer and its performance assessment for 510(k) clearance. However, it does not explicitly state "acceptance criteria" in a tabulated format. Instead, it discusses the study conducted to demonstrate "substantial equivalence" to predicate devices, which implies meeting performance benchmarks comparable to those devices.

Here's an interpretation of the performance data as "acceptance criteria" and how the study addresses them:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the "Discussion of Performance Data" and "Conclusions" sections, the implied acceptance criteria are that the VEGA RETIC performs comparably to the SYSMEX R-3000 for reticulocyte analysis and to the VEGA Hematology Analyzer for CBC and differential counts, meeting certain standards for correlation, precision, linearity, stability, and carry-over.

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

• Sample Size: 200 human whole blood samples.
• Data Provenance: The data used for comparative equivalence testing primarily focused on human whole blood samples. The document does not specify the country of origin, but given the submission is to the FDA, it is highly likely to be U.S. or internationally applicable clinical data. The study is prospective in the sense that these 200 samples were processed and then compared, implying a planned data collection for this evaluation rather than solely analyzing pre-existing records.

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

The document does not provide information regarding:

• The number of experts used.
• The qualifications of those experts.

The ground truth for the comparison was established by the predicate device (SYSMEX R-3000) and the VEGA Hematology Analyzer, which themselves are established and cleared devices. The study focuses on correlation between the devices rather than direct comparison to a human expert's judgment of cell counts.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method involving human experts for the test set. The comparison is directly between the new device and predicate devices.

5. 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 involving human readers and AI assistance was not done.
• This device is an automated hematology analyzer, not an AI-assisted diagnostic tool that supports human readers in interpreting images. Its output is quantitative measurements (cell counts) rather than qualitative interpretations requiring human review and potential AI enhancement.

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

• Yes, a standalone performance evaluation was conducted. The VEGA RETIC Automated Hematology Analyzer is designed to operate as a standalone instrument, providing complete blood counts, differential leukocyte counts, and reticulocyte counts without direct human intervention in the primary measurement process. The study evaluates the device's performance (correlation, precision, linearity, stability, carry-over) independently against predicate devices, which is a standalone assessment.

7. The Type of Ground Truth Used

The ground truth for the reticulocyte analysis was based on the performance of the legally marketed predicate device, the SYSMEX R-3000 Automated Reticulocyte Analyzer. For CBC and differential counts, the ground truth was based on the VEGA Hematology Analyzer. This is essentially a "predicate device comparison" as the ground truth.

8. The Sample Size for the Training Set

The document does not provide information about a specific "training set" or its size. As this is a 510(k) submission focused on demonstrating substantial equivalence to existing devices, the focus is on verification and validation against those predicate devices, rather than a de novo development process that might extensively detail training sets for machine learning models.

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

Since no training set information is provided, the method for establishing its ground truth is also not described. For an automated device like this, the "ground truth" for its internal calibration and operational algorithms would typically be established during its development using reference methods and extensive internal validation, but these details are not part of this 510(k) summary.

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