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The Sysmex® XS-1000iC is an automated hematology analyzer for in vitro diagnostic use in clinical laboratories and reference laboratories. The XS-1000iC will extend MCV stability to 48 hours.

The Sysmex® XS-1000iC is part of the XS-Series instrument line. It is a multi-parameter hematology analyzer intended to perform tests in anti-coagulated blood. The instrument consists of three principal units: (1) Main Unit which aspirates, dilutes, mixes and analyzes blood samples; (2) Auto Loader that supplies samples to the Main Unit automatically; (3) IPU (Information Processing Unit) which processes data from the Main Unit and provides the operator interface with the system. The XS-Series instruments provide accurate and precise test results for up to 21 analysis parameters in whole blood. These include: WBC White Blood Cell Count RBC Red Blood Cell Count HGB Hemoglobin HCT Hematocrit MCV Mean Cell Volume MCH Mean Cell Hemoglobin MCHC Mean Cell Hemoglobin Concentration PLT Platelet Count MPV Mean Platelet Volume RDW-SD RBC Distribution Width-SD RDW-CV RBC Distribution Width-CV NEUT%/# Neutrophil Percent and Count LYMPH%/# Lymphocyte Percent and Count MONO%/# Monocyte Percent and Count EO%/# Eosinophil Percent and Count BASO%/# Basophil Percent and Count The instrument processes approximately 60 samples per hour, depending on the mode used. The XS display various scattergrams, along with data for the reportable parameters. It displays the following analysis results on the IPU screen: WBC 5DIFF, White blood cells/Basophils, RBC pattern data of cell size distribution curves for platelet and analysis parameters. Analysis results and graphics can be printed on any of the available printers or transmitted to a Host computer. Sample abnormalities are indicated by abnormal marks, flags and error messages which appear on the LCD display screen and on the printout. This is an indication that the sample is not within the acceptable range and requires further review and investigation. There are two discrete testing options --- CBC and CBC with Diff. The XS performs analyses using the following methods: Sheath Flow DC Detection Method, Flow Cytometry Methods using a Semiconductor Laser and SLS-hemoglobin method. Blood cells pass through the aperature of the detector surrounded by sheath fluid using the sheath flow method. The principle of flow cytometry is also used. A semiconductor laser beam is emitted to the blood cells passing through the flow cell. The forward scattered light is received by the photodiode, and the lateral scattered light and lateral fluorescent light are received by the photo multiplier tube. This light is converted tinto electrical pulses, thus making it possible to obtain blood cell information. Hemoglobin is measured with the SLS-hemoglobin method using Sodium Lauryl Sulfate, which is an analysis method used in our previous instrumentation. A modification kit will be installed on a standard XS-1000i instrument where samples >48 hours are analyzed. This modification kit includes software and hardware changes and includes a modified reagent, Cellsheath (C). In this modification, the RBC/PLT dilution process will now be diluted using the Cellsheath (C) reagent after being warmed past 20℃. Software and hardware modifications include changes to the instrument's tubing and modification of the heating block. This only impacts the RBC/PLT dilution step. The WBC and HGB parameters are not impacted. This modification kit was not a change due to recall or corrective action, labeling change, technology or performance change or materials change.

The provided text is a 510(k) summary for the Sysmex XS-1000iC Automated Hematology Analyzer. It focuses on demonstrating substantial equivalence to a predicate device (Sysmex XE-2100DC) rather than providing a detailed study describing acceptance criteria and device performance in the format commonly seen for new, non-inferiority claims.

Here's an analysis based on the provided text, addressing your specific points:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state acceptance criteria in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy, precision ranges) for the XS-1000iC. Instead, it claims that the "Performance of the XS-1000iC is the same as the XE-2100DC" and that "Comparison of the XS-1000iC to the XE-2100DC demonstrated substantial equivalence."

The core claim is about the extension of MCV stability to 48 hours. This can be considered an acceptance criterion.

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

The document does not specify the sample size used for the test set for the XS-1000iC study.

It mentions:

• "A modification kit will be installed on a standard XS-1000i instrument where samples >48 hours are analyzed."
• "A modification kit was installed on a standard XS-1000i instrument where samples >48 hours are analyzed." (Table 1 describing XS-1000iC)
• "A modification kit was installed on a standard XE-2100 instrument where samples >48 hours are analyzed." (Table 1 describing XE-2100DC)

This suggests that the evaluation involved samples analyzed at greater than 48 hours to confirm the extended MCV stability claim. However, no specific number of samples or details on their provenance (country, retrospective/prospective) are provided for the XS-1000iC verification itself. The "Equivalency Data" section simply states, "Performance of the XS-1000iC is the same as the XE-2100DC. Comparison of the XS-1000iC to the XE-2100DC demonstrated substantial equivalence." This implies that the performance data for the XE-2100DC, which was cleared under K051459, is being leveraged without explicitly detailed new performance studies for the XS-1000iC in this document.

3. 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)

This is not applicable to this type of device and submission. Hematology analyzers measure blood cell parameters using automated methods. Ground truth is typically established by reference methods or validated manual counts, not by expert interpretation of images or clinical cases in the way that, for example, a CAD (Computer-Aided Detection) system for radiology would use expert radiologists. The "ground truth" for parameter measurement would be the highly controlled and validated reference measurements.

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

This is not applicable for a hematology analyzer measuring objective parameters. Adjudication methods are typically used in clinical trials or image interpretation studies where there's subjectivity or a need for consensus among multiple human reviewers.

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

This is not applicable. This is a standalone diagnostic device, not an AI-assisted interpretation tool for human readers. No MRMC study was done, as there are no human "readers" in the context of this automated measurement device.

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

Yes, the Sysmex XS-1000iC is an automated hematology analyzer, meaning its performance is inherently standalone (algorithm/instrument only) without human intervention in the primary measurement process itself. The "modification kit" involves software and hardware changes to the instrument to enable the extended MCV stability.

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

For hematology analyzers, the ground truth for parameters like MCV, WBC, RBC, HGB, etc., is typically established through:

• Reference methods: Highly precise and accurate manual counting methods or other validated automated methods.
• Calibration materials: Certified reference materials with known values traceable to international standards.

The document does not explicitly detail the specific ground truth methods used for the XS-1000iC testing, but it is implied to be based on the established and validated methods for the predicate device and general hematology practice.

8. The sample size for the training set

The document does not specify a "training set" sample size. This is a 510(k) submission for a device modification, suggesting the underlying algorithms were developed and "trained" much earlier for the predicate device. The current submission focuses on demonstrating "substantial equivalence" for the modified device, implying a verification/validation approach rather than a new algorithm training phase.

9. How the ground truth for the training set was established

As there is no explicit mention of a training set for the XS-1000iC modification in this document, the method for establishing ground truth for a training set is not provided. For the initial development of such an analyzer's algorithms, ground truth would have been established through a combination of reference methods, extensive sample testing, and potentially correlation with clinical outcomes, but these details are not part of this 510(k) summary for a modification.

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