(300 days)
The Sysmex XN-L analyzer is a quantitative multi-parameter automated hematology analyzer intended for in vitro diagnostic use in screening patient populations found in clinical laboratories. The XN-L analyzer classifies and enumerates the following parameters in whole blood: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, NEUT%H, LYMPH%4, 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, pleural, and synovial fluids. Whole blood should be collected in K2 or K3EDT A anticoagulant and peritoneal, pleural, and synovial fluids in K2EDTA anticoagulant to prevent clotting of fluid. The use of anticoagulants with CSF specimens is neither required nor recommended.
The performance of this device has not been established in pediatric patients under the age of 2 years.
The Sysmex XN-L analyzer is a quantitative multi-parameter automated hematology analyzer intended for in vitro diagnostic use in screening patient populations found in clinical laboratories. The XN-L analyzer classifies and enumerates whole blood and bodyfluid parameters by means of electrical impedance, laser light scattering, and fluorescentlabeling. Tests are performed on venous and capillary whole blood samples collected in K2 or K3 EDTA anticoagulant and body fluids (peritoneal, pleural and synovial) collected in K2EDTA anticoagulant and cerebrospinal fluid that is not collected in anticoagulant. The instrument consists of two principal units: (1) Main Unit which will aspirate, dilute, mix, and analyze whole blood and body fluid samples and (2) Pneumatic Unit which supplies pressure and vacuum to the analyzer. The XN-L analyzer performs analysis using the following methods: DC Sheath Flow Detection Method, Flow Cytometry Methods using a Semiconductor Laser, and SLS- hemoglobin Method. Particle characterization and identification is based on detection of forward scatter, fluorescence, and adaptive cluster analysis. The XN-L analyzer automatically classifies cells from whole blood and body fluids and carries out all processes automatically from aspiration of the sample to outputting the results.
The XN-L has an external monitor with touch screen capability that is used to operate the instrument and process data from the Main Unit. The monitor also allows operator interfacing with the instrument by use of a panel keyboard.
The provided text describes a 510(k) premarket notification for the Sysmex® XN-L Automated Hematology Analyzer, asserting its substantial equivalence to a predicate device, the Sysmex XN-Series (XN-10, XN-20) Automated Hematology Analyzer (K112605).
The text does not provide a table of acceptance criteria with reported device performance values, nor does it detail specific sample sizes, expert qualifications, adjudication methods, or MRMC study results for the test sets. It broadly states that "predetermined acceptance criteria were met" and that "Performance, verification, and validation testing were conducted to characterize the performance of the XN-L analyzer."
Therefore, based only on the provided text, I cannot fulfill all parts of your request with specific details. However, I can extract the information that is present and highlight the missing components.
Acceptance Criteria and Study for Sysmex® XN-L Automated Hematology Analyzer
Based on the provided FDA 510(k) summary, the device's performance was evaluated for substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
The document states that "predetermined acceptance criteria were met" and describes the types of performance evaluations conducted. However, it does not provide a table with specific quantitative acceptance criteria or the numerical results of these tests.
Performance Evaluations Conducted (Details not provided beyond type):
| Performance Metric | Acceptance Criteria (Not Detailed) | Reported Device Performance (Not Detailed) |
|---|---|---|
| Whole Blood Analysis | Substantial equivalence to predicate device (Sysmex XN-Series (XN-10, XN-20) K112605) based on performance characteristics. Acceptance criteria details not provided. | Accuracy, Precision (Reproducibility & Repeatability), Linearity, Carryover, Stability, Reference Intervals (Verification), Limits of Blank, Detection, and Quantitation. The document states these evaluations were conducted and demonstrate substantial equivalence. Specific numerical results are not provided. |
| Body Fluid Analysis | Substantial equivalence to predicate device (Sysmex XN-Series (XN-10, XN-20) K112605) based on performance characteristics. Acceptance criteria details not provided. | Accuracy, Precision (Reproducibility & Repeatability), Linearity, Carryover, Stability, Limits of Blank, Detection, and Quantitation. The document states these evaluations were conducted and demonstrate substantial equivalence. Specific numerical results are not provided. |
2. Sample Size Used for the Test Set and Data Provenance
- The document does not specify the exact "sample size used for the test set." It generically states "Clinical testing was conducted on the XN-L analyzer."
- The document does not specify the data provenance (e.g., country of origin, retrospective or prospective). It implies the data was collected as part of clinical testing for this submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not provided in the document. The device is an "Automated Differential Cell Counter," which typically relies on established methods and comparative performance to a predicate device or reference method, rather than subjective expert consensus for ground truth on individual cases.
4. Adjudication Method for the Test Set
- This information is not provided in the document. Given the nature of an automated cell counter, adjudication methods as typically used in imaging or diagnostic interpretation studies are unlikely to be directly applicable in the same way. Performance is likely assessed by comparing automated counts to reference methods.
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
- An MRMC study is not applicable to this device. This device is an automated hematology analyzer that performs quantitative measurements of blood and body fluid parameters. It is not an AI-assisted diagnostic tool that helps human readers interpret medical images or perform similar tasks. Therefore, there is no "human-in-the-loop" performance improvement to measure.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, implicitly. The entire study described is a "standalone" performance evaluation of the Sysmex XN-L analyzer. Its function is to autonomously classify and enumerate cells and parameters in blood and body fluids. The "Performance Testing" section details various evaluations (accuracy, precision, linearity, etc.) of the algorithm/device's direct output.
7. The Type of Ground Truth Used
- The document does not explicitly state the "type of ground truth" (e.g., pathology, outcomes data). For an automated hematology analyzer, ground truth is typically established by:
- Reference Methods: Such as manual microscopy (for cell counts and differentials), flow cytometry, or spectrophotometry (for hemoglobin), performed by highly trained medical technologists.
- Reference Instruments: Comparison to an established, highly accurate reference instrument.
- Predicated Device Comparison: The primary method of demonstrating substantial equivalence here is by showing comparable performance to the legally marketed predicate device (Sysmex XN-Series).
8. The Sample Size for the Training Set
- This device is an automated analyzer (a hardware/software system) for clinical laboratory measurements, not a machine learning model that undergoes explicit "training" in the typical sense with a "training set." Therefore, the concept of a "training set" as understood in AI/ML is not applicable here. The device's algorithms are pre-programmed and validated through the described performance studies.
9. How the Ground Truth for the Training Set was Established
- As explained in point 8, the concept of a "training set" for this type of medical device is not applicable.
§ 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.”