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The VEGA™ Hematology Analyzer is a quantitative, automated in vitro diagnostic analyzer capable of performing the following twenty six (26) hematological parameters: white blood cells (leukocytes) -WBC, red blood cells (erythrocytes) -RBC, hemoglobin -HGB, hematocrit -HCT, mean corpuscular volume -MCV, mean corpuscular hemoglobin -MCH, mean corpuscular hemoglobin concentration -MCHC, red blood cell distribution width -RDW, platelets -PLT, plateletcrit -PCT, platelet distribution width -PDW, mean platelet volume -MPV, lymphocyte (number) -LYM#, lymphocyte (percent of WBC) -LYM%, monocyte (number) -MON#, monocyte (percent of WBC) -MON%, basophil (number) -BAS#, basophil (percent of WBC) -BAS%, neutrophil (number) -NEU#, neutrophil (percent of WBC) -NEU%, eosinophil (number) -EOS#, eosinophil (percent of WBC) -EOS%, Atypical Lymphocyte (number) -ALY#, Atypical Lymphocyte (percent of lymphocyte number) -ALY%, Large Immature cell (number) -LIC#, Large Immature cell (percent of WBC) -LIC%.

Only twenty (20) parameter printout will be made available for diagnostic use in the United States (eliminating PCT, PDW, ALY%, ALY#, LIC%, LIC#).

The VEGA™ Hematology Analyzer is a quantitative, automated in vitro diagnostic analyzer capable of performing twenty six (26) hematological parameters. It utilizes five (5) different reagents: VEGADIL™, VEGALYSE™, VEGACLEAN™, EOSINOFIX™, and BASOLYSE™. The counting principle for WBC, RBC, and PLT is based on impedance variation. HGB is measured by spectrophotometry. HCT is measured by a specialized electronic device that adds pulse heights. MCH, MCHC, and MCV are calculated indices. RDW is a coefficient of variation of RBC distribution. MPV is a platelet index. Leukocyte differential counts are performed using cytochemistry with Eosinofix™ reagent, impedance to measure volume, and optical transmission measurement to obtain information on the internal structure of the cells.

Here's an analysis of the provided text, focusing on acceptance criteria and the study used to demonstrate them for the VEGA™ Hematology Analyzer.

The document describes the VEGA™ Hematology Analyzer and its performance characteristics through clinical studies conducted at three university hospital sites. The studies aimed to demonstrate the precision and accuracy of the device.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly state "acceptance criteria" but presents performance metrics (reproducibility and linearity claims) that serve as de-facto acceptance criteria against the reported actual performance. For accuracy, the R² values indicate correlation with predicate devices, which can be interpreted as demonstrating acceptable performance against established methods.

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

• Sample Sizes (N):
  • Site 1: 190 samples
  • Site 2: 238 samples
  • Site 3: 216 samples
  • Total samples used for accuracy: 190 + 238 + 216 = 644 samples.
  • Reproducibility (within run) calculated from 20 results of the same sample.
• Data Provenance: The clinical studies were performed at three hospital university sites. The country of origin is not explicitly stated for the samples, but the sponsor is based in MONTPELLIER, FRANCE. The document implies the studies were conducted in a "typical setting" (e.g., hospital labs), suggesting real-world, clinical samples. The study design ("clinical study") and the mention of "widest distribution of normal and abnormal specimens" suggest that these were prospective collections or at least representatively selected samples rather than purely retrospective database pulls. Since it's a 510(k) submission, the data is typically considered clinical trial data, which would be prospective for this type of device validation.

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

• Number of Experts: Not explicitly stated. The document mentions "Manual differential count were performed for the samples at all three sites." This implies trained laboratory personnel, but the specific number of individuals or their "expert" qualifications (e.g., pathologist, specific experience level) are not detailed.
• Qualifications of Experts: Not explicitly stated beyond "operators of various levels of experience and educational backgrounds" for the VEGA Analyzer testing and "Manual differential count were performed... according to NCCLS guidelines H20-A" for ground truth, which implies trained medical laboratory scientists.

4. Adjudication Method for the Test Set

• Adjudication Method: Not explicitly stated. For the manual differential counts, it's mentioned they were performed according to NCCLS guidelines H20-A. These guidelines generally prescribe specific methodologies for manual counts, and any adjudication process (e.g., multiple counts, arbitration by a senior technologist/pathologist) would typically fall under those standard laboratory practices, but isn't detailed here. For the accuracy comparison (VEGA vs. predicate devices), the predicate devices themselves served as the reference for comparison, not an adjudication process among human readers.

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

• MRMC Study: No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly described. The study compared the VEGA™ Hematology Analyzer's performance against established predicate devices (TECHNICON H2®, ABBOT CELL-DYN® 3500, COULTER STKS®) and manual differential counts, which is a common approach for IVD devices. It did not involve comparing human readers' performance with and without AI assistance (as the VEGA is not an "AI" device in the modern sense of a diagnostic aid to humans, but rather an automated analyzer).
• Effect Size of Human Reader Improvement: Not applicable, as this was not an MRMC study and the device does not provide "AI assistance" for human readers in the traditional sense.

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

• Standalone Performance: Yes, the entire clinical study described (reproducibility, linearity, carryover, accuracy against predicate devices) represents the standalone performance of the VEGA™ Hematology Analyzer as an automated system. This device is an "algorithm only" (automated analyzer) type without a human-in-the-loop component for interpreting its primary results. The reference to "operators of various levels of experience and educational backgrounds" refers to the users operating the device, not interpreting results with "human-in-the-loop" AI assistance.

7. The Type of Ground Truth Used

The ground truth used for performance evaluation was a combination of:

• Predicate Devices: For most parameters (WBC, RBC, HGB, etc.), the results from legally marketed and established hematology analyzers (TECHNICON H2®, ABBOT CELL-DYN® 3500, and COULTER STKS®) served as the reference for accuracy comparisons.
• Expert Consensus / Gold Standard Manual Methods: For differential counts, "Manual differential count were performed... according to NCCLS guidelines H20-A." These manual counts, performed by trained laboratory personnel, represent a universally accepted ground truth for leukocyte differential.
• Defined Reference Values: For reproducibility values, specific reference values (e.g., 10 10³/mm³ for WBC) were used. These would correspond to known control material values or target ranges.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not specified. The document describes a 510(k) submission, which focuses on validation data (test set) for substantial equivalence. The training set for the device's internal algorithms (e.g., how it learned to classify cells or establish thresholds) is not discussed. This information is typically proprietary to the manufacturer and not required in a 510(k) summary focused on performance data.

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

• Training Set Ground Truth: Not specified. As with the training set sample size, the methodologies for developing and training the internal algorithms of the VEGA™ Hematology Analyzer are not detailed in this 510(k) summary. This would have been part of the internal development and verification process by ABX.

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