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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.

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The XN-Series modules (XN-10, XN-20) are quantitative multi-parameter automated hematology analyzers intended for in vitro diagnostic use in screening patient populations found in clinical laboratories.

The XN-Series modules classify and enumerate the following parameters in whole blood: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT (PLT-I, PLT-F), NEUT%/#, LYMPH%/#, MONO%/#, EO%/#, BASO%/#, IG%/#, RDW-CV, 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%/#, PMN%/#, and TC-BF parameters in cerebrospinal fluid (CSF), serous fluids (peritoneal, pleural) and synovial fluids. Whole blood should be collected in K₂ or K₃EDTA anticoagulant and, Serous and Synovial fluids in K₂EDTA anticoagulant to prevent clotting of fluid. The use of anticoagulants with CSF specimens is neither required nor recommended.

The Sysmex® XN-Series modules (XN-10, XN-20) are multi-parameter hematology analyzers intended to perform tests on whole blood samples collected in K₂ or K₃EDTA and body fluids (pleural, peritoneal and synovial) collected in K₂ anticoagulant. It can also perform tests on CSF which should not be collected in any anticoagulant. The instrument consists of four principal units: (1) Two Main Units (XN-10, XN-20) which aspirate, dilute, mix, and analyze blood and body fluid samples; (2) Two Auto Sampler Units (SA-10, SA-20) 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: RF/DC Detection Method, 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, TC-BF (Total Count) & 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.

Here's a breakdown of the acceptance criteria and study information for the Sysmex XN-Series Automated Hematology Analyzers, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document primarily focuses on establishing substantial equivalence to a predicate device (Sysmex XE-5000) rather than explicitly stating acceptance criteria values for each parameter. Instead, it states that "Studies were performed to evaluate the equivalency of the XN-Series Automated Hematology analyzers (Modules XN-10, XN-20) to the XE-5000 Automated Hematology analyzer. Results indicated equivalent performance."

However, it does describe the types of tests performed to demonstrate performance:

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

The document does not explicitly state the sample size used for the test set. It mentions "Studies were performed," but no specific numbers of samples are provided.

Regarding data provenance, the document does not specify the country of origin of the data or whether it was retrospective or prospective.

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 given text. The document refers to "manufacturer's specifications" for performance but does not detail how ground truth for the clinical performance data was established or if it involved human expert review for individual cases.

4. Adjudication Method for the Test Set

This information is not provided in the given text.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly conducted or described in the provided text. The study focused on demonstrating "equivalency" to a predicate device rather than comparing human reader performance with and without AI assistance from the device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, a standalone performance study was conducted. The document states: "Data consisting of Accuracy, Precision, Linearity and Carryover were collected to show performance to the manufacturer's specification for the Body Fluid mode." This implies a technical validation of the instrument's (algorithm's) ability to measure parameters directly, independent of human interpretation of the results beyond standard quality control.

7. The Type of Ground Truth Used

The type of ground truth used is implicit in the nature of hematology analyzers:

• For parameters like WBC, RBC, HGB, etc., the ground truth would typically be established by reference methods or calibrated controls that are considered highly accurate.
• For the body fluid mode, the "manufacturer's specifications" would define the expected accurate values against which the device's measurements (Accuracy, Precision, Linearity, Carryover) are compared. These specifications are likely derived from internal validation studies using reference methods.

8. The Sample Size for the Training Set

The document does not provide information regarding a training set. As this is an automated hematology analyzer performing quantitative measurements based on established physical and chemical principles (RF/DC Detection, Sheath Flow DC Detection, Flow Cytometry), traditional machine learning "training sets" are not typically a primary focus for regulatory submissions of this type. The device's "training" would involve the design and calibration of its internal algorithms and measuring channels.

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

Since a traditional "training set" for a machine learning model is not explicitly mentioned as relevant in this context, the method for establishing its ground truth is not applicable/provided. The device's operational principles are based on known physics and established clinical measurement techniques.

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