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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 venous and capillary whole blood: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, NEUT%/#, LYMPH%#, MON0%#, EO%#, 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, peritoneal, pleural, and synovial fluids. Whole blood should be collected in K2 or K3EDTA anticoagulant and peritoneal, 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-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 body fluid parameters by means of electrical impedance, laser light scattering, and fluorescent labeling. 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 the Sysmex XN-L Automated Hematology Analyzer and its substantial equivalence to a predicate device, the Sysmex XN-Series (XN-10, XN-20). The document focuses on regulatory approval rather than a detailed study report. Therefore, some information requested might not be explicitly present or might require inference.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "predetermined acceptance criteria were met" but does not explicitly list the specific quantitative acceptance criteria for each measured parameter. It generally describes performance evaluations conducted.

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

The document does not explicitly state the specific sample size used for the test set. It mentions "Real World Data had been collected for additional samples that included the pediatric population for patients less than 2 years of age."
The provenance of the data (country of origin, retrospective or prospective) is not specified.

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 document. The study described is a performance evaluation of an automated analyzer against a predicate device, focusing on analytical performance rather than expert-based ground truth for interpretation.

4. Adjudication Method for the Test Set

Adjudication methods are typically employed when expert interpretation or consensus is required for ground truth establishment. As the document does not detail expert involvement for ground truth, an adjudication method is not mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study is mentioned. The study described focuses on the analytical performance of the automated analyzer itself, comparing it to a predicate device, not on the improvement of human readers with AI assistance.

6. Standalone (Algorithm Only) Performance

Yes, a standalone performance evaluation was conducted. The entire document describes the performance testing of the Sysmex XN-L Automated Hematology Analyzer (algorithm/device only) to demonstrate its substantial equivalence to the predicate device. The performance characteristics of the analyzer itself were evaluated.

7. Type of Ground Truth Used

The ground truth used for this type of analytical performance study would generally be:

• Reference laboratory methods or highly accurate comparative methods.
• The results from the predicate device (Sysmex XN-Series) for comparative purposes, as the study aims to show substantial equivalence.
• Known concentrations for linearity and limit of detection/quantitation studies.

The document implies the use of these types of reference measurements but does not explicitly detail the specific ground truth for each parameter.

8. Sample Size for the Training Set

The document does not provide details on a "training set" sample size. This type of regulatory submission for an automated hematology analyzer typically focuses on verification and validation studies (test sets) rather than separate training and testing sets in the context of machine learning model development.

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

As a training set is not explicitly mentioned in the context of machine learning model development, the method for establishing its ground truth is not provided. The study focuses on demonstrating the analytical performance of the device itself.

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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):

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.

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