(165 days)
The XN-Series modules (XN-11, XN-21) are quantitative multi-parameter automated hematology analyzers intended for in vitro diagnostic use in screening patient populations found in clinical and reference laboratories.
The XN-Series modules classify and enumerate the following parameters in whole blood: WBC, RBC, HCT, MCV, MCH, MCHC, PLT, NEUT%H, LYMPH%#, MONO%#, E0%#, BASO%#, IG%#, RDW-SD, MPV, NRBC#/%, RET%/#, IPF, IRF, RET-He and has a Body Fluid mode for body fluids. The Body Fluid mode enumerates the WBC-BF, RBC-BF, MN%#, and TC-BF parameters in body fluids (peritoneal, pleural and synovial). Whole blood should be collected in K2 or K3EDTA anticoagulant and peritoneal, pleural and synovial fluids in K2EDTA anticoagulant to prevent clotting of fluid.
The Sysmex® XN-Series modules (XN-11, XN-21) are multi-parameter hematology analyzers intended to perform tests on whole blood samples collected in K2 or K3EDTA anticoagulant and body fluids (pleural, peritoneal and synovial) collected in K2 anticoagulant. The XN-Series modules (XN-11, XN-21) are part of the family of XN-Series devices (K112605) cleared Oct 19, 2012 with modifications to stabilize the HCT/MCV parameters to within +8% at room temperature (18-26°C) for 24 hours and refrigerated temperature (2-8°C) for 48 hours for commercial and reference laboratories. The difference between the XN-11 and XN-21 is the presence of the WPC Channel in the XN-21.
The instrument consists of four principal units: (1) Two Main Units (XN-11, XN-21) which aspirate, dilute, mix, and analyze blood and body fluid samples; (2) Two Auto Sampler Units (SA-10 for a single module, or SA-20 for two modules) which supply 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 XN-Series analyzers perform analysis using the following methods: Sheath Flow DC Detection Method, and Flow Cytometry Methods using a Semiconductor Laser. Particle characterization and identification is based on detection of forward scatter, fluorescence and adaptive cluster analysis. The XN-Series analyzers automatically classify cells from whole blood and body fluids and carry out all processes automatically from aspiration of the sample to outputting the results.
The body fluid analysis mode of the XN-Series analyzers 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, Total Count (TC-BF) & RBC (RBC-BF) counts found in the body fluid.
Analysis results and graphics are displayed on the IPU screen. They can be printed on any of the available printers or transmitted to a Host computer.
The provided text describes the Sysmex® XN-Series (XN-11, XN-21) Automated Hematology Analyzers and their substantial equivalence to the Sysmex® XE-5000 Automated Hematology Analyzer.
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a neat table format for all parameters. Instead, it states that "Data consisting of Accuracy, Precision, Linearity and Carryover were collected to show performance to the manufacturer's specification for the Whole Blood and Body Fluid mode." It then broadly concludes that "This analysis supports the claim that the XN-Series analyzers are substantially equivalent to the XE-5000."
To infer the acceptance criteria and a "reported device performance," we would need the actual study reports for Accuracy, Precision, Linearity, and Carryover, which are not detailed in this summary. The summary only broadly states that the studies were performed and indicated equivalent performance.
Therefore, a table of explicit acceptance criteria and corresponding reported device performance values cannot be fully constructed from the given text. The document states that the performance met the manufacturer's specifications and showed equivalence to the predicate device.
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions that "Studies were performed to evaluate the equivalency of the XN-Series Automated Hematology analyzers (Modules XN-11, XN-21) to the XE-5000 Automated Hematology analyzer." However, it does not specify the sample size used for these equivalency studies.
Regarding data provenance, the document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The document does not provide any information about experts used to establish ground truth or their qualifications. Given that this is an automated hematology analyzer, the ground truth is typically established by reference methods or comparison to a predicate device, rather than expert interpretation of images or clinical assessments.
4. Adjudication Method for the Test Set:
The document does not describe any adjudication method. This is expected as the device is an automated analyzer, and adjudication (e.g., 2+1, 3+1) is typically relevant for human interpretation of data, where discrepancies between readers need a defined resolution process.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly mentioned or described. This type of study is more common for diagnostic imaging devices where human readers interpret medical images with and without AI assistance. The Sysmex XN-Series is an automated hematology analyzer, so its primary function is direct measurement and classification, not as an AI assistance tool for human interpretation in the context of MRMC studies.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Yes, the studies described are inherently standalone performance evaluations of the automated hematology analyzer. The device itself is designed for automated classification and enumeration of blood and body fluid parameters without human intervention in the primary measurement process. The "Accuracy, Precision, Linearity and Carryover" studies evaluate the device's technical performance independently.
7. Type of Ground Truth Used:
The ground truth for the performance studies (Accuracy, Precision, Linearity, and Carryover) would have been established by:
- Comparison to a predicate device (Sysmex® XE-5000 Automated Hematology Analyzer): The core of the 510(k) submission is to demonstrate substantial equivalence to this predicate. This means results from the XN-Series would be compared against results from the XE-5000.
- Reference Methods: For parameters like cell counts, hemoglobin, etc., ground truth often involves established reference methods, although these are not explicitly detailed in the summary.
- Manufacturer's Specifications: The document states performance was shown "to the manufacturer's specification," implying these specifications serve as an internal ground truth or target for performance.
8. Sample Size for the Training Set:
The document does not provide any information about a training set or its sample size. Automated hematology analyzers typically use algorithms developed through extensive R&D, and while there's an internal "training" process for the algorithms, it's not usually presented as a distinct "training set" in the same way machine learning models are for regulatory submissions in other domains. The performance studies described are validation or test sets.
9. How the Ground Truth for the Training Set Was Established:
Since no training set information is provided, how its ground truth was established is not stated in the document.
§ 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.”