(330 days)
The Sysmex® XT-4000i is a quantitative multi-parameter automated hematology analyzer intended for in vitro diagnostic use in screening patient populations found in clinical laboratories. The XT-4000i classifies and enumerates the following parameters for whole blood: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, NEUT%/#, LYMPH%/#, MONO%/#, EO%/#, BASO%/#, IG%/#, RDW-CV, RDW-SD, MPV, RET%/#, IRF, RET-He and has a Body Fluid mode for body fluids. The Body Fluid mode enumerates the WBC-BF, RBC-BF, MN%/#, PMN%/# and TC-BF# parameters in cerebrospinal fluids (CSF), serous fluids (peritoneal, pleural) and synovial fluids. Serous and Synovial fluids should be collected in K2EDTA to prevent clotting of fluid. The use of anticoagulants with CSF specimens is not required or recommended.
The XT-4000 i is the same as the XT-2000 i which is part of the XT- Series and has a Body Fluid mode the same as the XE-5000. It is an automated hematology analyzer which consists of four principle units: (1) Main Unit which aspirates, dilutes, mixes, and analyzes whole blood and body fluid samples; (2) Sampler Unit which 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; (4) Pneumatic Unit which supplies pressure and vacuum from the Main Unit.
The Body Fluid analysis mode of the XT-4000 i uses the 4DIFF scattergram & the RBC distribution obtained from a specialized analysis sequence to calculate & display the WBC (WBC-BF) counts, mononuclear cell (MN) / polymorphonuclear cell (PMN) counts & percentages, TC-BF (Total Count) & RBC (RBC-BF) counts found in the body fluid.
Acceptance Criteria and Device Performance Study for Sysmex® XT-4000i Automated Hematology Analyzer
This response summarizes the acceptance criteria and the study conducted to demonstrate the Sysmex® XT-4000i Automated Hematology Analyzer meets these criteria, based on the provided 510(k) submission information.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Sysmex® XT-4000i are implicitly established by demonstrating substantial equivalence to its predicate device, the XE-5000 Body Fluid Mode, across various performance metrics. The submission focuses on proving that the XT-4000i's Body Fluid mode performs equivalently to the XE-5000's Body Fluid mode for the enumerated parameters.
| Acceptance Criteria (Measured Performance Aspect) | Reported Device Performance (Sysmex® XT-4000i vs. XE-5000 Body Fluid Mode) |
|---|---|
| Accuracy (for Body Fluid mode parameters: WBC-BF, RBC-BF, MN%/#, PMN%/#, TC-BF#) | Data collected indicated equivalent performance between the XT-4000i and XE-5000 Body Fluid Mode. |
| Precision (for Body Fluid mode parameters: WBC-BF, RBC-BF, MN%/#, PMN%/#, TC-BF#) | Data collected indicated equivalent performance between the XT-4000i and XE-5000 Body Fluid Mode. |
| Linearity (for Body Fluid mode parameters: WBC-BF, RBC-BF, MN%/#, PMN%/#, TC-BF#) | Data collected indicated equivalent performance between the XT-4000i and XE-5000 Body Fluid Mode. |
| Carryover (for Body Fluid mode parameters: WBC-BF, RBC-BF, MN%/#, PMN%/#, TC-BF#) | Data collected indicated equivalent performance between the XT-4000i and XE-5000 Body Fluid Mode. |
| Overall Performance | Results indicated equivalent performance to the XE-5000 Body Fluid Mode, supporting substantial equivalence. |
Note: The submission implies that the acceptance criteria for these parameters are the manufacturer's specifications, which the XT-4000i's Body Fluid mode met, thereby demonstrating equivalency to the predicate device.
2. Sample Size Used for the Test Set and Data Provenance
The provided summary does not explicitly state the specific numerical sample size used for the test set or the data provenance (e.g., country of origin of the data, retrospective or prospective). It only states that "Studies were performed to evaluate the equivalency of the XT-4000i to the XE-5000 Body Fluid Mode." and "Data consisting of Accuracy, Precision, Linearity and Carryover was collected to show performance to the manufacturer's specification for the Body Fluid mode."
Without more detailed study reports, these specifics cannot be determined from the available text.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the submitted summary. Hematology analyzer performance studies typically involve comparison to reference methods or manual counts, but the involvement and qualifications of specific "experts" for ground truth establishment are not detailed here.
4. Adjudication Method for the Test Set
This information is not provided in the submitted summary. Given the nature of a hematology analyzer, ground truth is usually established through comparative testing with established reference methods rather than through expert adjudication in the same way an imaging or diagnostic AI might require.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. This type of study is typically relevant for interpretative devices where human readers' performance is augmented by an AI. The Sysmex® XT-4000i is an automated hematology analyzer, which performs direct measurement and enumeration, not an interpretative AI requiring human readers.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, the study demonstrating the performance of the Sysmex® XT-4000i was a standalone performance study. The device is an automated analyzer, meaning it operates without human intervention in the analysis process once the sample is loaded. The performance data for accuracy, precision, linearity, and carryover directly reflect the algorithm's and hardware's capabilities in analyzing the body fluid parameters.
7. The Type of Ground Truth Used
The ground truth used for evaluating the Sysmex® XT-4000i's Body Fluid mode performance would have been established by comparison to established reference methods (e.g., manual cell counts, other validated automated analyzers, or calibrated standards) for the relevant parameters (WBC-BF, RBC-BF, MN%/#, PMN%/#, TC-BF#). The submission states that the performance was shown "to the manufacturer's specification," which implies these specifications are validated against recognized reference standards.
8. The Sample Size for the Training Set
The concept of a "training set" is not applicable in the context of this device's submission. The Sysmex® XT-4000i is an automated hematology analyzer based on established measurement principles (Hydro Dynamic Focusing, flow cytometry, SLS-hemoglobin method), not a machine learning or AI-driven diagnostic device that requires explicit training data in the same way. Its development would involve calibration and validation, but not a "training set" as understood in AI/ML.
9. How the Ground Truth for the Training Set was Established
As stated above, the device does not utilize a "training set" in the context of AI/ML. Its operational parameters and algorithms are designed based on physical and chemical principles of cell analysis, and its accuracy is validated against known standards and reference methods during its development and testing.
§ 864.5220 Automated differential cell counter.
(a)
Identification. An automated differential cell counter is a device used to identify one or more of the formed elements of the blood. The device may also have the capability to flag, count, or classify immature or abnormal hematopoietic cells of the blood, bone marrow, or other body fluids. These devices may combine an electronic particle counting method, optical method, or a flow cytometric method utilizing monoclonal CD (cluster designation) markers. The device includes accessory CD markers.(b)
Classification. Class II (special controls). The special control for this device is the FDA document entitled “Class II Special Controls Guidance Document: Premarket Notifications for Automated Differential Cell Counters for Immature or Abnormal Blood Cells; Final Guidance for Industry and FDA.”