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The BC-3600 auto hematology analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in clinical laboratories. The BC-3600 auto hematology analyzer provide complete blood count (WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, PLT, MPV) and leukocyte 3-Part differential (Lymph#, Mid#, Gran#, Lymph%, Mid%, Gran%) for whole blood specimens, collected in a salt of EDTA [dipotassium (K2) or tripotassium (K3)] obtained by venipuncture or fingerstick. The purpose of the BC-3600 Auto Hematology Analyzer is to identify the normal human patient, with normal system-generated parameters, from patients whose results require additional studies.

The BC-3600Auto Hematology Analyzer is a quantitative, automated hematology analyzer and leukocyte differential counter for In Vitro Diagnostic Use in clinical laboratories. It is only to be used by trained medical professionals to identify the normal patient, with all normal system-generated parameters, and to flag or identify patient results that require additional studies. The analyzer provides analysis results of 16 parameters of human blood and three histograms.

The BC-3600 Auto Hematology Analyzer system consists of:

• The analyzer (BC-3600)
• Reagents (M-30D DILUENT, M-30CFL LYSE, M-30R RINSE, PROBE CLEANSER)
• Controls (BC-3D Control (High, Normal, Low levels))
• Calibrator (SC-CAL PLUS Calibrator)

The analyzer provides analysis results of 16 parameters (WBC, Lymph#, Mid#, Gran#, Lymph%, Mid%, Gran%, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, PLT, MPV) of human blood and three histograms (WBC Histogram, RBC Histogram, PLT Histogram).

The provided text describes the Mindray BC-3600 Auto Hematology Analyzer and its substantial equivalence to the predicate device, BC-3200 Hematology Analyzer.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" against which the device performance is directly compared column-by-column. Instead, it describes performance characteristics and states that the device "met the pre-defined specification of the difference limits" or "passed specifications." We can infer the acceptance criteria from the context of these statements and the reported performance.

For method comparison against the predicate device (BC-3200), the acceptance criteria are implicitly defined by the parameters r (correlation coefficient), slope (95% CI), and intercept (95% CI) and the statement that biases met pre-defined limits. For flagging ability, the percentages for sensitivity, specificity, and efficiency serve as the reported performance, with implicit acceptance criteria for these values. For carryover, an explicit acceptance criterion is given.

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

• Method Comparison and WBC Flagging Ability:
  • Sample Size: 1222 K2EDTA whole blood samples.
  • Data Provenance: Three actual user sites, two in China and one in the U.S. Patients aged 1 day to 100 years, with 547 females, 672 males, and 3 unknown. Retrospective/prospective not explicitly stated, but "Patient's samples covered the normal and most abnormal conditions" suggests selection, possibly from archives or collected for the study.
• Precision/Reproducibility: Not explicitly stated as a fixed test set size for patient samples, but control materials were run in duplicate twice a day for 20 days at three clinical sites. For within-run precision, ten replicates of whole blood samples were used around medical decision levels and analytical measuring range limits at three clinical sites.
• Linearity Range: Not explicitly stated as a fixed test set size, but "7 subsequent dilutions" were prepared and "three (3) from each of the 7 dilutions" were measured.
• Comparison of Whole Blood Mode and Predilute Mode Sample:
  • Sample Size: 61 pairs of samples.
  • Data Provenance: K2EDTA collection tube, not specified if US or China.
• Comparison of Venipuncture and Fingerstick Sample:
  • Sample Size: 52 paired specimens.
  • Data Provenance: Collected from donors (not specified where, but tested at the U.S. site).
• Comparison of K2EDTA and K3EDTA Anticoagulants Samples:
  • Sample Size: 60 paired fresh whole blood samples.
  • Data Provenance: Not specified where, but tested at an actual user site in the U.S.
• Sample Stability:
  • Whole Blood: 35 normal and abnormal samples collected at Finlay Laboratory (U.S. site).
  • Predilute: 25 normal and abnormal samples collected at NSH site (location not specified, likely one of the clinical sites mentioned earlier).
• Reference Interval:
  • Sample Size: 255 donors (124 adult male, 131 adult female).
  • Data Provenance: Not specified, but adult donors aged 19-85.
• Determination of LoB, LoD, LoQ:
  • Sample Size: 5 blank samples and 5 low-level samples, tested 12 times (blank) or 5 times (low-level).
  • Data Provenance: One clinical laboratory in China.

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

• Method Comparison and WBC Flagging Ability:
  • Number of Experts: Not explicitly stated. The text mentions "A 400 cell WBC differential was performed on two smears per CLSI H20-A2." This typically implies trained laboratory professionals, but the exact number and qualifications (e.g., years of experience, specific certifications) are not provided. CLSI H20-A2 (Reference Leukocyte (WBC) Differential Count (Proportional) and Evaluation of Instrumental Methods) guides this process, which requires expert review.

4. Adjudication Method for the Test Set

• Method Comparison and WBC Flagging Ability: The text states "A 400 cell WBC differential was performed on two smears per CLSI H20-A2." This standard often outlines procedures for resolving discrepancies, but the specific adjudication method (e.g., 2+1, 3+1) is not detailed in the provided summary. It implies expert review for ground truth, but not a specific reader adjudication process for the study.

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, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study focusing on the improvement of human readers with vs. without AI assistance was not performed. This device is an automated hematology analyzer, not an AI-assisted diagnostic tool for human interpretation of images. The comparison was primarily between the new device and the predicate device, and between the device's flagging ability and a manual differential (human expert determination).

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Yes, the performance data presented (e.g., method comparison, WBC flagging ability, precision, linearity, carryover) represents the standalone performance of the BC-3600 Auto Hematology Analyzer. The device is designed to be an automated analyzer providing quantitative results.

7. The Type of Ground Truth Used

• Method Comparison (vs. Predicate): The ground truth for this comparison was the results obtained from the predicate device (BC-3200).
• WBC Flagging Ability: The ground truth for this was established by manual differential counts performed by experts on peripheral blood smears, following CLSI H20-A2 guidelines.
• Precision/Reproducibility: Used commercial control materials (BC-3D control Low, Normal and High).
• Linearity Range: Used dilutions prepared from fresh whole blood and commercial high-value analogs for WBC and PLT.
• Comparisons (Modes, Samples, Anticoagulants): Used the BC-3600 results in different configurations/conditions to show equivalence.
• Sample Stability: Used the BC-3600 results at different time points compared against initial readings.
• Reference Interval: Determined by testing samples from 255 healthy donors.
• LoB, LoD, LoQ: Established using blank samples (diluent) and low-level samples created by adding whole blood to diluent.

8. The Sample Size for the Training Set

• The document describes validation and verification studies for a medical device submitted for 510(k) clearance, not the development or training of an AI algorithm. Therefore, there is no mention of a training set sample size as it pertains to AI/machine learning. The studies described are for demonstrating the performance of the final device against established standards and predicates. This device uses the "Coulter principle of Impedance method" and "Colorimetric method," classical laboratory techniques, not explicitly an AI/ML algorithm that would require a "training set."

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

• As stated above, this document does not describe the development or training of an AI algorithm, but rather the validation of an automated hematology analyzer based on traditional principles. Therefore, the concept of "ground truth for the training set" does not apply in this context.

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