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The COULTER GEN S System with IRF and MRV Parameters is a quantitative, automated hematology analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories. The COULTER GEN-S System also provides automated Reticulocyte analysis.

An automated differential cell counter is a device used to identify and classify one or more of the formed elements of blood.

The Immature Reticulocyte Fraction expresses the number of early reticulocytes as a proportion of the total reticulocyte count. Mean reticulocyte volume (MRV) is the average cell volume of the reticulocytes, determined by the VCS Technology algorithm and is reported in femtoliters (fL). This 510(k) Premarket Notification provides information demonstrating that Coulter hematology analyzers with IRF and MRV parameters are substantially equivalent to products previously cleared for this use. The COULTER hematology analyzers with IRF and MRV parameters are compared to Sysmex™ hematology analyzers with the IRF parameter. The MRV parameter is presented as a discussion of the calculation and supported by precision data from a COULTER GEN-S System analyzer. Unlike the Sysmex R-1000, R-3000 and RAM-1 analyzers which are dedicated to the measurement of reticulocyte parameters, the COULTER hematology analyzers, including the GEN.S, measure multiple CBC and differential parameters in addition to the measurement of reticulocyte parameters.

Here's a breakdown of the acceptance criteria and study information for the COULTER® Hematology Analyzers with IRF & MRV Parameters, based on the provided text:

Acceptance Criteria and Device Performance

The provided document describes a submission for substantial equivalence to predicate devices, rather than a study with pre-defined acceptance criteria for a new device. Therefore, the "acceptance criteria" are implicitly the performance metrics of the predicate devices and the demonstration of equivalent performance by the new device. The study aims to show that the COULTER® device performs comparably to or better than its predicates.

It's important to note that specific numerical "acceptance criteria" for the COULTER device itself are not explicitly stated as pass/fail thresholds in this summary. Instead, the submission relies on demonstrating substantial equivalence to the predicate devices through comparative accuracy and imprecision experiments. The values presented for the COULTER device are its performance measures, which are then compared to the predicate's performance and statistical targets like a mean difference of zero and low standard deviation for imprecision.

Study Information

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

   • IRF Accuracy Analysis (GEN-S vs Sysmex SE9500): N = 332 samples.
   • IRF and MRV Paired Imprecision results (GEN-S): N = 90 samples for each.
   • Data Provenance: Not explicitly stated but usually for such studies, it's clinical samples, likely from the country where the study was conducted (presumably the US, given the FDA submission). It is not specified if the data is retrospective or prospective.

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

   • This is not a diagnostic imaging or classification device where ground truth is established by expert review. For hematology analyzers, the "ground truth" or reference method is typically another established, often manual or highly validated, laboratory method or a predicate device.
   • In this case, for IRF accuracy, the Sysmex SE9500 (predicate device) served as the comparator method against which the COULTER GEN-S's performance was evaluated.

3. Adjudication method for the test set:

   • Not applicable. As described above, this is a comparison against a predicate device, not an expert-adjudicated ground truth.

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 a study for an automated hematology analyzer, not an AI assistance tool for human readers. Therefore, an MRMC study is not relevant and was not performed.

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

   • Yes, implicitly. The performance data presented (IRF accuracy and IRF/MRV imprecision) are for the COULTER® Hematology Analyzers as automated, standalone devices. They are designed to provide quantitative measurements without human intervention in the primary measurement and calculation process. The comparison is between two automated systems.

6. The type of ground truth used:

   • For IRF Accuracy, the ground truth was the predicate device's measurement (Sysmex SE9500). This is a common approach in demonstrating substantial equivalence for new IVD devices by comparing them to an already legally marketed and validated device.
   • For IRF and MRV Imprecision, the ground truth is internal consistency and reproducibility of the device itself over repeated measurements, rather than an external gold standard.

7. The sample size for the training set:

   • Not specified. The document primarily focuses on the validation of the device for regulatory submission, presenting performance data (test set results). Information about the training set size (if any, for internal algorithm development) is not typically included in such summaries.

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

   • Not specified. Similar to the training set size, the specifics of how internal algorithm development and potential training data ground truth were established are not part of this regulatory summary.

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