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The IRF parameter of the R-Series analyzers is intended for in-vit-vouse in --clinical laboratories. Its clinical use is to monitor bone marrow suppression and recovery in terms of erythropoiesis in situations of previous cancer chemotherapeutic bone marrow suppression and bone marrow transplantation. Qualified laboratory personnel are responsible for review of all abnormal results.

The R-1000, R-3000 and RAM-1 are table-top analyzer systems for automated reticulocyte counting. These instruments are dedicated flow cytometers which dilute and stain whole blood with a fluorescent dye (Auromine-O), then count and measure fluorescence and scatter of stained blood cells. The fluorescence intensity is measured, and the analyzer identifies the reticulocytes based on fluorescence and scatter. The fluorescent intensity of the reticulocytes is displayed on the analyzer as a scattergram, and this display is separated into three regions: Low Fluorescence Intensity (LFR), Middle Fluorescence Intensity (MFR), and High Fluorescence Intensity (HFR). These regions are reported as a ratio or percentage(sum = 100%), in addition to the analyzer's reporting total reticulocyte count and RBC count. The IRF parameter is determined by the sum of the MFR (Middle Fluorescence Ratio) and HFR (High Fluorescence Ratio) {MFR+HFR=IRF}.

Here's an analysis of the provided 510(k) summary regarding the Sysmex™ IRF parameter, focusing on acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes the intended use and performance of the Sysmex™ IRF parameter by comparing it to predicate methodologies. However, it does not explicitly state specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) for the IRF parameter itself. Instead, it makes a general claim of similarity or superiority to existing methods.

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

• Sample Size: The document does not specify the exact sample size for the test set used in the reported clinical studies. It vaguely mentions "clinical studies."
• Data Provenance: The document does not explicitly state the country of origin for the data or whether the studies were retrospective or prospective. It only refers to "clinical studies" and "published clinical studies."

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

The document does not provide information on the number of experts used or their qualifications to establish ground truth for the test set. Given the nature of the parameter (monitoring bone marrow activity), the "ground truth" would likely be derived from established clinical markers and patient outcomes rather than expert image interpretation.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Was an MRMC study done? No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device (IRF parameter) is an automated laboratory test, not an imaging device requiring human reader interpretation. Therefore, a study to assess human reader improvement with AI assistance is not applicable.
• Effect size of human readers improving with AI vs. without AI assistance: Not applicable.

6. Standalone (Algorithm Only) Performance Study

• Was a standalone study done? Yes, the reported performance is inherently a standalone (algorithm only) performance. The Sysmex R-Series analyzers automatically calculate the IRF parameter. The clinical studies mentioned evaluate the predictive value of this automated parameter in monitoring bone marrow activity. The device is not designed as an AI assistant for human interpretation but rather as a direct measurement tool.

7. Type of Ground Truth Used

The ground truth for evaluating the IRF parameter's effectiveness appears to be:

• Clinical Outcomes/Established Clinical Markers: The ground truth is implied to be actual bone marrow suppression and recovery, as measured by established clinical indicators like WBC, ANC, and reticulocyte counts, and ultimately, patient outcomes in terms of erythropoiesis in the context of chemotherapy and bone marrow transplantation.

8. Sample Size for the Training Set

The document does not provide information on the sample size used for any training set. As this is an older 510(k) (1997) for a parameter derived from established flow cytometry principles (measuring fluorescence intensity), it's highly probable that traditional algorithms were used, not machine learning or AI models in the modern sense requiring extensive training sets with labeled ground truth in the same way. The device's underlying technology relies on physical measurements and thresholds.

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

The document does not provide information on how ground truth was established for any training set. As mentioned, the technology likely predates modern AI training methodologies. The parameters (LFR, MFR, HFR, IRF) are based on the intrinsic fluorescent properties of reticulocytes at different maturation stages, and the "ground truth" for identifying these populations would have been established through extensive research into flow cytometry and reticulocyte biology. The "training" would have involved optimizing physical parameters and thresholds within the instrument's design based on known biological characteristics, rather than a data-driven machine learning approach.

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