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The COULTER® AcT™ 5diff AL Hematology Analyzer is a quantitative, automated hematology Analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories.

The Beckman Coulter, Inc. (BCI) Coulter® Ac•T™ 5diff Autoloader Hematology Analyzer (AcT™ 5diff AL) is a bench top laboratory instrument, designed for In Vitro diagnostic use in clinical laboratories. The AcT™ 5diff AL provides automated complete blood counts (CBC) and leukocyte differential counts. The instrument is microprocessor driven with a PC that performs data processing and data management activities.

Here's a breakdown of the acceptance criteria and study information for the COULTER® AcT™ 5diff Autoloader (AL) Hematology Analyzer, based on the provided document.

Acceptance Criteria and Reported Device Performance

The provided document primarily focuses on demonstrating substantial equivalence to a predicate device and outlining the device's intended use and modifications. It does not explicitly list specific acceptance criteria (e.g., minimum accuracy percentages, precision targets) or detailed performance results in the format of a table. The "modification" section implies improvement characteristics without specifying them.

To adequately answer this, one would typically expect to see a section titled "Performance Testing" or "Clinical Performance" with quantitative data. The absence of such a section in this summary is notable.

However, based on what is implied by a 510(k) submission for a modified device, the "acceptance criteria" for a modified device like this would be that its performance characteristics are equivalent to or better than those of the predicate device, especially for the "improved performance characteristics" mentioned.

Therefore, the table below reflects what would typically be expected, but the specific numerical values for acceptance criteria and reported performance are NOT present in the provided text.

Study Details

Given the limited information in the provided document (which is a 510(k) summary, not a full study report), many of these details are not explicitly stated. This document primarily declares substantial equivalence and modifications.

1. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

   • Sample Size: Not specified.
   • Data Provenance: Not specified (country, retrospective/prospective).
   • Note: Typical 510(k) submissions for such devices would involve testing with a range of patient samples (normal, abnormal) to assess performance across various clinical conditions.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

   • Number of Experts: Not specified.
   • Qualifications of Experts: Not specified.
   • Note: For leukocyte differential counts, manual microscopy performed by experienced morphologists (e.g., clinical hematologists or highly trained medical technologists) is the gold standard.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not specified.
   • Note: When multiple experts are used, a common adjudication method is to use consensus among a certain number of readers, with a tie-breaker (e.g., a third or fourth expert) if initial agreement is not reached.

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:

   • No, this is highly unlikely. This device is an automated hematology analyzer, not an AI-assisted diagnostic tool that helps human readers interpret images or data. It generates the results that clinicians then interpret. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable to this type of device.

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

   • Yes, implicitly. The device itself is an automated analyzer, meaning it operates in a standalone fashion to generate CBC and differential counts. Its performance would have been evaluated directly against a reference method (likely manual microscopy for differentials) without human intervention in the device's analytical process.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • For CBC parameters (e.g., RBC, HGB, PLT): Likely established using reference methods on validated instruments or highly precise manual techniques.
   • For Leukocyte Differential Counts: Most likely established through expert manual microscopy following established laboratory protocols. This often involves reviewing stained blood smears by trained morphologists, potentially with consensus if multiple reviewers are used.

7. The sample size for the training set:

   • Not specified.
   • Note: Automated hematology analyzers are typically developed and "trained" (i.e., their algorithms are optimized) using a diverse and large set of patient samples to ensure robust performance across various physiological and pathological conditions.

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

   • Similar to the test set, the ground truth for the training set would have been established through a combination of reference methods for quantitative parameters and expert manual microscopy for leukocyte differentials. This iterative process of running samples, having experts determine the "true" values, and then refining the device's algorithms is standard in the development of such automated systems.

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