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The COULTER LH 750 Hematology Analyzer is a quantitative, automated hematology analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories. The COULTER LH 750 Hematology Analyzer provides automated Reticulocyte analysis and enumeration of nucleated red blood cells (NRBCs) as well as an automated method for enumeration of RBCs and WBCs in body fluids.

The product is an automated hematology analyzer capable of supplying a complete blood cell analysis and includes a differential leukocyte cell count. The product also provides automated reticulocyte analysis and enumeration of nucleated red blood cells (NRBCs) as well as an automated method for enumeration of RBCs and WBCs in body fluids. The COULTER LH 750 Hematology Analyzer utilizes the Coulter Principle for enumerating and sizing blood cells, automatic diluting and mixing for sample processing and a single beam photometer for hemoglobinometry. It uses COULTER VCS (volume, conductivity, light scatter) technology for WBC Differential analysis and classification and reticulocyte analysis. The analyzer uses a reagent system consisting of an isotonic diluent, lytic reagents to lyse the red cells without significantly affecting the white cells and an instrument cleaner. Additionally, all systems include reagents used for reticulocyte staining and analysis. For body fluids analysis, the specimen is aspirated into the LH 750 Analyzer via the manual mode and is diluted in separate WBC and RBC baths. The Coulter Method of counting cells is used to detect and measure changes in electrical resistance when a cell, suspended in a conductive diluent, passes through a small aperture.

The provided document K061574, a 510(k) summary for the COULTER® LH 750 Hematology Analyzer, is primarily a notification of a modification to the device, specifically a revised MCV accuracy specification. It does not contain detailed information about a comprehensive study proving the device meets acceptance criteria for all its listed functions (e.g., differential leukocyte count, reticulocyte analysis, NRBC enumeration, body fluid analysis).

The document mentions that the modification relates to the "draft labeling submitted in the original Premarket notification (K011342) to reflect a revised MCV accuracy specification." This implies that the initial and comprehensive studies would have been part of the K011342 and K030606 submissions, which are referenced as legally marketed predicate devices.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, ground truth, experts, and MRMC studies are not available in the provided text. The following table and explanations reflect the information that can be extracted from the given document, focusing on the modification rather than a complete re-evaluation of the entire device.

Acceptance Criteria and Reported Device Performance (Focused on MCV Accuracy Specification)

Missing Information:

• The actual numerical value of the original MCV accuracy specification.
• The actual numerical value of the revised MCV accuracy specification.
• The specific data and statistical analysis demonstrating that the device meets the revised MCV accuracy specification.

Study Information (Based on the available document)

Given the nature of the document (a 510(k) for a revised MCV accuracy specification), the details of a full study often found in original 510(k) submissions are not present. The focus here is on what can be inferred about the change rather than a complete de novo study validation.

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: Not specified in this document. Information on the number of samples used to validate the revised MCV accuracy is absent.
   • Data Provenance: Not specified. It's likely that data would be from internal Beckman Coulter studies, but details on country of origin or whether it was retrospective or prospective are not provided for this specific modification. For the original device, it would have been part of K011342 and K030606.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Number of Experts: Not specified.
   • Qualifications of Experts: Not specified. Given the nature of a hematology analyzer, ground truth for MCV would typically involve reference methods and quality controls, potentially with expert oversight for sample preparation and analysis.

3. Adjudication method for the test set:

   • Not specified. This is typically relevant for subjective assessments (e.g., image review), which MCV measurement is not. For quantitative measurements like MCV, validation usually involves comparison to a reference method or validated control materials.

4. 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:

   • Not applicable. This device is an automated hematology analyzer, not an AI-assisted diagnostic imaging tool with human readers. Therefore, an MRMC study and effects on human reader improvement are not relevant here.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • The COULTER® LH 750 Hematology Analyzer is an automated device, meaning its primary function is standalone performance (algorithm only). The document describes it as "a quantitative, automated hematology analyzer."
   • The modifications to its MCV accuracy specification would inherently relate to its standalone performance.

6. The type of ground truth used:

   • Likely Reference Methods and Calibrated Controls: For MCV, ground truth would typically be established using validated reference methods (e.g., manual packed cell volume, or highly calibrated reference instruments) and internationally recognized hematology calibrators and internal quality control materials (some of which are mentioned as qualified reagents, such as COULTER S-CAL® Hematology Calibrator).

7. The sample size for the training set:

   • Not applicable/Not specified for this modification. This document pertains to a specification revision for an existing, already-marketed device. It's not a de novo algorithm development that would explicitly describe a "training set" in the context of machine learning. The device's underlying principles (Coulter Principle, VCS technology) are well-established. Any "training" or calibration would have occurred during the original device development (K011342) and subsequent routine calibration of individual instruments.

8. How the ground truth for the training set was established:

   • Not applicable/Not specified for this modification. As above, the concept of a training set in the AI/ML sense isn't directly applicable here. For the original development, ground truth for calibration would have been established using reference methods and calibrated materials.

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