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The XR-Series module (XR-10) is a quantitative multi-parameter automated hematology analyzer intended for in vitro diagnostic use in screening patient populations found in clinical laboratories.

The XR-Series module classifies and enumerates 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, 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 K2EDTA 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 XR-Series module (XR-10) is a quantitative multi-parameter hematology analyzer intended to perform tests on whole blood samples collected in K2 or K3EDTA and body fluids (pleural, peritoneal and synovial) collected in K2EDTA anticoagulant. The analyzers can also perform tests on CSF, which should not be collected in any anticoagulant. The XR-Series analyzer consist of four principal units: (1) One Main Units (XR-10) which aspirates, dilutes, mixes, and analyzes blood and body fluid samples; (2) Two Auto Sampler Units (SA-10, SA-01) 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.

This document describes the acceptance criteria and the studies conducted to prove that the Sysmex XR-Series (XR-10) Automated Hematology Analyzer meets these criteria, demonstrating substantial equivalence to its predicate device, the Sysmex XN-20.

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) clearance letter does not explicitly present a neatly formatted table of acceptance criteria alongside the reported performance for all parameters. Instead, it describes various performance studies (Precision, Linearity, Analytical Specificity/Interferences, Sample Stability, Detection Limit, Carry-Over, Comparison Studies, Matrix Studies, Bridging Studies, Clinical Studies, and Expected Values/Reference Range) and states that the XR-10 met "manufacturer's specifications or predefined acceptance criteria requirements" for each.

However, based on the provided data, we can infer some general acceptance criteria, particularly from the method comparison study which uses correlation coefficient (r) and percent bias (%Bias) as metrics. The clinical sensitivity and specificity tables also present implied acceptance criteria based on the demonstrated performance.

Inferred Acceptance Criteria & Reported Performance (Selection of Key Metrics)

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

• Test Set Sample Size & Provenance:
  • Precision (Repeatability - Whole Blood): Residual K2EDTA whole blood samples for 10 replicates for target values, and three samples for other parameters. This was across three US clinical sites (Site 01, 05, 24).
  • Precision (Reproducibility - Whole Blood): XN CHECK whole blood control material, 90 results per control level (3 levels x 3 replicates x 2 runs x 5 days). Conducted at three US clinical sites.
  • Precision (Body Fluid): Residual peritoneal, pleural, and synovial fluid samples (K2EDTA) and CSF (no anticoagulant) for 10 replicates for target values. Conducted at three US clinical sites.
  • Linearity (Whole Blood & Body Fluid): Minimum of seven sample dilutions. Performed at one internal site.
  • Analytical Specificity/Interferences: Whole blood K2EDTA samples from donors. Number of samples not specified, but collected for this study purpose.
  • Sample Stability (Whole Blood): 8 unique leftover samples and 12 prospectively collected K2EDTA venous whole blood samples (20 samples total). Conducted at one internal site.
  • Sample Stability (Body Fluid): 12 unique de-identified leftover body fluid samples (3-CSF, 3-peritoneal, 3-pleural, 3-synovial). Conducted at 1 external site.
  • Detection Limit: Four blank samples and four low concentration samples for each parameter. Conducted across 2 XR-10 analyzers (implied internal or multi-site for the overall study context).
  • Carry-Over: High and low target concentration samples (number not specified). Conducted at three US clinical sites.
  • Comparison Studies (Whole Blood): 865 unique residual whole blood samples from pediatrics (

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The XR-Series module (XR-20) is a quantitative multi-parameter automated hematology analyzer intended for in vitro diagnostic use in screening patient populations found in clinical laboratories.

The XR-Series module classifies and enumerates 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, 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 K2EDTA 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 XR-Series module (XR-20) is a quantitative multi-parameter hematology analyzer intended to perform tests on whole blood samples collected in K2 or K3EDTA and body fluids (pleural, peritoneal and synovial) collected in K2EDTA anticoagulant. The analyzers can also perform tests on CSF, which should not be collected in any anticoagulant. The XR-Series analyzer consist of four principal units: (1) One Main Unit (XR-20) which aspirates, dilutes, mixes, and analyzes blood and body fluid samples; (2) One Auto Sampler Unit 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 XR-20 analyzer has an additional white progenitor cell (WPC) measuring channel and associated WPC reagents. The new WPC channel provides two separate flags for blasts and abnormal lymphocytes.

The provided FDA 510(k) Clearance Letter details the performance testing conducted for the Sysmex XR-Series (XR-20) Automated Hematology Analyzer to demonstrate its substantial equivalence to the predicate device, Sysmex XN-20. Due to the nature of the document being an FDA clearance letter summarizing performance studies rather than the full study reports, some requested details (e.g., exact sample provenance for all studies beyond "US clinical sites," specific qualifications for all experts, and the comprehensive list of acceptance criteria for all individual parameters in specific studies) are not exhaustively provided.

However, based on the information available, here's a breakdown of the acceptance criteria and the studies proving the device meets them:

Overall Acceptance Criteria & Study Design Philosophy:

The overarching acceptance criterion for this 510(k) submission is to demonstrate substantial equivalence to the predicate device, Sysmex XN-20 (K112605). This is primarily proven through:

• Analytical Performance Studies: Demonstrating that the XR-20 analyzer's performance (precision, linearity, analytical specificity, stability, limits of detection, carry-over) is "acceptable" or "met manufacturer's specifications/predefined acceptance criteria requirements."
• Method Comparison Studies: Showing a strong correlation and acceptable bias between the XR-20 and the predicate XN-20 for all claimed parameters across various patient populations and challenging samples.
• Clinical Sensitivity and Specificity Studies: For flagging capabilities, demonstrating acceptable agreement (sensitivity/specificity, PPA/NPA/OPA) with a reference method (manual microscopy) and the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't provide a single, consolidated table of all acceptance criteria for every parameter across all tests. Instead, it states that results "met manufacturer's specifications or predefined acceptance criteria requirements" for analytical performance tests, and provides specific correlation coefficients, slopes, intercepts, and mean differences/percent differences for method comparison studies.

Here's a partial table based on the quantifiable data presented for Method Comparison Studies (Whole Blood - Combined Sites), which is a key performance indicator for substantial equivalence. The "Acceptance Criteria" are implied by what is generally considered acceptable in hematology analyzer comparisons for FDA submissions (high correlation, small bias), and explicitly stated for certain parameters like HGB.

Implicit Acceptance Criteria (General expectation for Method Comparison based on FDA context):

• Correlation Coefficient (r): Typically > 0.95 (ideally > 0.98 or 0.99 for robust parameters)
• Slope: Close to 1.0 (ideally between 0.95 and 1.05)
• Intercept: Close to 0
• Mean Difference / % Mean Difference / Estimated Bias: Within clinically acceptable limits (often derived from biological variation or regulatory guidelines). The document explicitly mentions a bias limit for HGB: ±2% or 0.2 g/dL.

Table 1: Partial Acceptance Criteria and Reported Device Performance (Method Comparison - Whole Blood)

For other analytical performance studies (Precision, Linearity, Detection Limit, Carry-Over, Specificity, Stability), the document consistently states that the XR-20 "met manufacturer's specifications or predefined acceptance criteria requirements," supporting that specific numerical acceptance criteria were defined and achieved.

2. Sample Size and Data Provenance

• Test Set:

  • Whole Blood Method Comparison: A total of 865 unique residual whole blood samples.
  • Body Fluid Method Comparison: A total of 397 residual body fluid samples.
  • Provenance: All studies were conducted at three US clinical sites (for major studies like method comparison and reproducibility) or one internal site (for some linearity, stability, and matrix studies).
  • Retrospective/Prospective: Samples are described as "residual" (implying retrospective, de-identified leftover samples) or "prospectively collected" where specified (e.g., for some stability studies).

• Training Set: The document does not specify a training set for the algorithm, as this is a traditional in-vitro diagnostic (IVD) device (Automated Hematology Analyzer) which likely relies on fixed algorithms and established measurement principles (RF/DC Detection, Sheath Flow DC Detection, Flow Cytometry) rather than a machine learning model that requires explicit training data for its core functionality. The performance characterization is about its analytical capabilities, not about learning from a dataset to perform a task.

3. Number of Experts and Qualifications (for Ground Truth)

• Clinical Sensitivity and Specificity (Flagging Capabilities): The ground truth for flagging capabilities was established by "manual differential counts and peripheral blood smear review by experienced examiners using light microscopy (reference method) at each of the three external clinical sites." The exact number and specific qualifications (e.g., "radiologist with 10 years of experience") are not provided, but the term "experienced examiners" implies qualified personnel (e.g., clinical laboratory scientists, pathologists). Given this is a hematology analyzer, these would typically be clinical laboratory specialists or hematopathologists.

4. Adjudication Method (for the Test Set)

• Clinical Sensitivity and Specificity (Flagging): The document does not explicitly describe an adjudication method (e.g., 2+1, 3+1) for resolving discrepancies between multiple manual reviews. It states "peripheral blood smear review by experienced examiners," primarily using manual microscopy as the reference method. This implies there might be a single expert review or an internal consensus process, but no detail on conflict resolution is provided.

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

• No MRMC study was described. This type of study (MRMC) is typically performed for AI-assisted diagnostic tools where human reader performance is a direct outcome of interest and needs to be compared with and without AI assistance. The Sysmex XR-20 is an automated analyzer, a standalone device that performs measurements and classifications. While it outputs flags that may assist human review, its primary function isn't human-in-the-loop assistance in interpretation (like an AI for radiology image reading). Therefore, an MRMC study is not applicable for this device.

6. Standalone (Algorithm Only) Performance

• Yes, the primary performance studies are standalone algorithm/device performance. All analytical performance studies (Precision, Linearity, Detection Limit, Carry-Over, Analytical Specificity, Sample Stability) and the method comparison studies (comparing XR-20 results directly against the predicate XN-20) represent the standalone performance of the XR-20 analyzer. The device functions automatically without human input during the analysis process; therefore, human-in-the-loop performance is not directly evaluated as a primary outcome for its measurement capabilities.

7. Type of Ground Truth Used

• Analytical Ground Truth: For most analytical performance studies (Precision, Linearity, Detection Limits, Carry-Over), the "ground truth" is established by the performance of the predicate device (Sysmex XN-20) or by a well-controlled experimental setup (e.g., known dilutions for linearity, blank samples for LoB).
• Clinical Ground Truth (for flagging): For clinical sensitivity and specificity of flagging capabilities, the ground truth was expert consensus / manual review against peripheral blood smear using light microscopy. The document refers to this as the "reference method."

8. Sample Size for the Training Set

• As mentioned in point 2, no explicit training set for a machine learning algorithm is described. This device's core functionality relies on established physical and chemical principles and traditional signal processing for cell counting and classification, not a learnable AI model from a training data set in the typical sense.

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

• Since there's no described "training set" for an AI/ML algorithm, this point is not applicable in the context of this traditional IVD device. The "ground truth" for verifying its performance (as detailed above) was established through comparisons to a legally marketed predicate device (XN-20) and a gold standard manual method (microscopy).

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The CN-Series (CN-6000) is a fully automated coagulation analyzer intended for in vitro diagnostic use in the clinical laboratory. The instrument analyzes citrated plasma samples (3.2 % sodium citrate) collected from venous blood, using clotting, chromogenic and immunoassay methods.

The performance of this device has not been established in neonate and pediatric patient populations.

The CN-Series (CN-6000) coagulation analyzer is an automated blood coagulation instrument which can analyze samples using clotting, chromogenic and immunoassay methods. Analysis results are displayed on the IPU (Information Processing Unit) screen. They can be printed on external printers or transmitted to a host computer.

Sold separately from the instrument are the associated reagents, controls, calibrators, and consumable materials. The subject of this 510(k) notification is the analyzer together with the reagent applications which perform the coagulation tests:

• Prothrombin Time (PT) seconds and PT INR with Dade® Innovin®
• Activated Partial Thromboplastin Time (APTT) with Dade® Actin® FSL
• Fibrinogen (Fbg) with Dade® Thrombin Reagent
• Antithrombin (AT) with INNOVANCE® Antithrombin
• D-dimer with INNOVANCE® D-Dimer.

The analysis principles used on the instrument are reflected by the reagent application testing provided in this submission and are described in the table below. These reagents were selected to show the analytical technology of the instrument while also selecting commonly used applications in coagulation laboratories in the United States.

This document describes the acceptance criteria and the study that proves the device meets the acceptance criteria for the Sysmex CN-6000 Automated Blood Coagulation Analyzer.

The provided text is a 510(k) clearance letter for an in vitro diagnostic device, specifically an automated blood coagulation analyzer. The information focuses on demonstrating substantial equivalence to a predicate device (Sysmex CS-5100 K150678) rather than providing detailed acceptance criteria and proof of exceeding them in the format typically seen for novel AI/ML devices. Therefore, the information has been extracted and interpreted as closely as possible to the requested structure, with explanations where the requested information is not explicitly present due to the nature of the document.

1. Table of Acceptance Criteria and Reported Device Performance

For an in vitro diagnostic device like the CN-6000, acceptance criteria are generally defined as meeting performance specifications comparable to the predicate device and within clinically acceptable ranges. The "acceptance criteria" for each study are generally defined as the results meeting these pre-established standards. The reported device performance is presented as the outcomes of these studies.

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The XQ-Series analyzer (XQ-320) is a quantitative multi-parameter automated hematology analyzer intended for in vitro diagnostic use in screening patient populations found in clinical laboratories.

The XQ-320 analyzer classifies and enumerates the following parameters in venous and capillary whole blood samples collected in K2 or K3 EDTA anticoagulant: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, RDW-SD, RDW-CV, MPV, NEUT%/#, LYMPH%/#, and MXD%/#.

The Sysmex XQ-Series (XQ-320) automated hematology analyzer is a multi-parameter hematology analyzer intended for in vitro diagnostic use in screening patient populations found in clinical laboratories. The XQ-320 analyzer classifies and enumerates whole blood parameters by DC (Direct Current) detection method and non-cyanide HGB analysis method (Colorimetric method) on whole blood samples collected in K2 or K3EDTA anticoagulant. The XQ-320 analyzer consists of one unit which aspirates and dispenses diluent to prepare blood dilutions and analyzes whole blood samples. The operator must mix the sample manually then introduce the sample tube to the aspiration pipette with the cap off, and presses the start switch to execute aspiration and analysis. The XQ-320 analyzer uses a built-in monitor to operate the analyzer and process data.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) summary for the Sysmex XQ-Series (XQ-320) Automated Hematology Analyzer.

Important Note: This document is a 510(k) summary, which provides a high-level overview of the studies. It does not contain the detailed acceptance criteria for every test or the raw data. The acceptance criteria described are inferred from the statements that "All results met the predefined acceptance criteria" or similar. The "reported device performance" in the table below will be the results stated as meeting those (unspecified) criteria.

1. Table of Acceptance Criteria and Reported Device Performance

The document describes various performance studies. Below is a table summarizing the reported performance, with the understanding that for each, "predefined acceptance criteria" were met. Specific numeric acceptance criteria are generally not provided in this summary.

2. Sample Sizes and Data Provenance

• Test Set (Method Comparison & Sensitivity/Specificity):
  • Method Comparison: 628 unique residual and prospectively collected venous whole blood samples from pediatrics (

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The XW-100 Automated Hematology Analyzer (XW-100) is a quantitative automated hematology analyzer intended for in vitro diagnostic use to classify and enumerate the following parameters for venous whole blood anticoagulated with K2/K3 EDTA: WBC, RBC, HGB, HCT, MCV, PLT, LYM%, Other WBC%, NEUT%, LYM#, Other WBC#, and NEUT#. It is not for use in diagnosing or monitoring patients with primary or secondary chronic hematologic diseases/ disorders, oncology patients, critically ill patients, or children under the age of 2.

The XW-100 Automated Hematology Analyzer for CLIA Waived Use is an electrical resistance type blood cell counter. This technology may be variously referred to as direct current (DC) or impedance. The analyzer uses a human whole blood specimen and produces results for 12 hematology parameters, including the basic complete blood count (CBC), 3 part white blood cell (WBC) differential, and MCV.

The provided text is a 510(k) premarket notification letter from the FDA to Sysmex America, Inc. regarding their XW-100 Automated Hematology Analyzer. It primarily details the device's intended use, technological principles, and a comparison to a predicate device, focusing on a software update.

Crucially, this document does not contain the detailed study information typically requested for acceptance criteria and device performance proofs. It explicitly states that the device is "as safe and effective as the predicate device" and that "The results of the design control activities demonstrate that the device is substantially equivalent to the predicate device." This suggests that the detailed performance studies were likely conducted for the original predicate device (K172604/CW170012), and for this new submission (K210346), the focus was on demonstrating that the software update did not negatively impact the previously established safety and effectiveness.

Therefore, many of the requested fields cannot be directly answered from the provided text. However, I can infer some information based on the context of a 510(k) submission for a software update.

Here's an attempt to answer the questions based on the provided text and general 510(k) submission understanding for software updates:

Acceptance Criteria and Device Performance Study Information:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of acceptance criteria or specific reported device performance metrics for the XW-100 with software version 1.14. It relies on the principle of "substantial equivalence" to the predicate device (XW-100 with software version 1.03). The acceptance criterion for this submission is that "the device is as safe and effective as the predicate device" and that the "proposed software update was implemented in accordance to design controls and risk management."

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document does not specify the sample size used for any test set or the data provenance. For a software update submission, testing would typically involve verifying that the new software performs identically or acceptably compared to the previous version across a range of samples. This would likely be internal validation data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable/Not mentioned. The device is an automated hematology analyzer, and its "ground truth" for parameters like WBC, RBC, etc., is typically established by reference methods or validated calibrated instruments, not subjective expert interpretations as would be the case for imaging diagnostics. The context here is a software update for an already cleared device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/Not mentioned. No human expert adjudication method would be used for an automated hematology analyzer's numerical output for the specified parameters.

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

Not applicable. This device is an automated hematology analyzer, not an AI-assisted diagnostic tool that human readers would use to improve their interpretation of images or data. It produces direct numerical measurements.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, the device (the XW-100 Automated Hematology Analyzer) inherently operates in a "standalone" fashion, as it is an automated instrument performing quantitative measurements. The evaluation for this 510(k) was focused on the software update (version 1.03 to 1.14) and ensuring it maintained the performance of the predicate device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For an automated hematology analyzer, the "ground truth" for its measurements (WBC, RBC, HGB, HCT, MCV, PLT, LYM%, Other WBC%, NEUT%, LYM#, Other WBC#, and NEUT#) is established through:

• Reference methods: Highly accurate and precise laboratory methods.
• Validated reference materials/calibrators: Materials with known and traceable values.
• Comparison to predicate devices: As stated, the updated device is compared to the original XW-100 with version 1.03.

8. The sample size for the training set

Not applicable/Not mentioned. This document pertains to a 510(k) software update for an automated instrument, not a de novo AI/ML algorithm that requires a distinct "training set" in the context of machine learning model development. The software update is likely to be code changes rather than a re-trained model.

9. How the ground truth for the training set was established

Not applicable/Not mentioned, as there is no mention of a typical "training set" for an AI/ML model for this software update.

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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® UD-10 Fully Automated Urine Particle Digital Imaging Device for locating, digitally storing and displaying microscopic images captured from urine specimens. The Sysmex® UD-10 locates and presents particles and cellular elements based on size ranges. The images are displayed for review and classification by a qualified clinical laboratory technologist on the Urinalysis Data Manager (UDM). This device is intended for in vitro diagnostic use in conjunction with a urine particle counter for screening patient populations found in clinical laboratories.

The Sysmex® UD-10 is a medical device that captures images of cells and particles found in urine with a camera and displays the images on a display screen. The displayed data consists of images of individual particles that are extracted from the original captured whole field images. The device sorts urine particle images based on their size into eight groups (Class 1-8). These images are transferred to the UDM (Urinalysis Data Manager), where the operator enters the classification of the particle images based on their visual examination. The classification of the particles by the operator is a designation of what type of particles are observed (e.g., WBCs, RBCs, casts, bacteria).

The Sysmex UD-10 is a device for locating, digitally storing, and displaying microscopic images captured from urine specimens. It presents particles and cellular elements based on size ranges for review and classification by a qualified clinical laboratory technologist.

Here's an analysis of the acceptance criteria and the studies performed:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria values for agreement percentages in the precision, repeatability, and method comparison studies (except for the minimum requirement for overall agreement in reproducibility and repeatability). However, it does provide conclusions based on the results meeting statistical thresholds. The carryover study had an acceptance criterion within ±1.00%.

2. Sample Size and Data Provenance

Reproducibility Study:

• Sample size: 240 evaluations (from 120 samples of abnormal and normal QC material, processed twice a day for a minimum of 5 days).
• Data provenance: Prospective, U.S. clinical sites (4 sites). Commercially available MAS® UA control material was used.

Repeatability Study:

• Sample size: 170 evaluations (from an unspecified number of normal residual urine samples, each assayed in 5 replicates).
• Data provenance: Prospective, U.S. clinical sites (4 sites). Normal residual urine samples, collected without preservatives.

Carryover Study:

• Sample size: Not explicitly stated as a total number of samples, but involved High and Low concentration samples for BACT (4 sites), WBC (3 sites), and RBC (3 sites). Each sample was split into 3 aliquots (3 high, 3 low) and run consecutively. Results are presented for 3 replicates of high and 3 replicates of low samples per parameter per site.
• Data provenance: Prospective, U.S. clinical sites (4 sites for BACT, 3 for WBC and RBC). Residual urine samples, collected without preservatives.

Method Comparison Study:

• Sample size: 746 abnormal and normal urine samples.
• Data provenance: Prospective, U.S. clinical sites (4 sites). Residual urine samples from daily routine laboratory workload, collected without preservatives.

3. Number of Experts and Qualifications for Ground Truth

Reproducibility Study:

• Number of experts: One technologist per site (total of 4 technologists across 4 sites).
• Qualifications: "Technologist." No specific experience level is mentioned.

Repeatability Study:

• Number of experts: Two technologists per sample per site, who independently reviewed and identified particle images.
• Qualifications: "Technologist." No specific experience level is mentioned.

Carryover Study:

• Number of experts: One technologist per site.
• Qualifications: "Technologist." No specific experience level is mentioned.

Method Comparison Study:

• Number of experts: Two technologists per sample per site. One classified elements on the UD-10, and a second performed visual read using manual light microscopy.
• Qualifications: "One technologist" and "a second technologist." No specific experience level is mentioned.

4. Adjudication Method

Reproducibility, Repeatability, and Carryover Studies:

• No explicit adjudication method is described. For repeatability, two technologists independently reviewed images, and "Each technologist's results were treated and recorded as an independent observation."

Method Comparison Study:

• No explicit adjudication method is described. One technologist used the UD-10, and another used manual microscopy. Their results were compared.

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

There is no mention of a formal MRMC comparative effectiveness study in the sense of evaluating how much human readers improve with AI vs. without AI assistance. The study compares the UD-10 device's performance (which incorporates digital imaging and sorting for human review) against manual microscopy. The UD-10 is a digital imaging device, not strictly an 'AI' device in the typical sense of providing automated diagnosis or enhanced AI assistance to human readers for diagnostic interpretation (beyond presenting sorted images). The study is essentially a method comparison between the UD-10-assisted workflow and traditional manual microscopy.

6. Standalone Performance (Algorithm Only)

The Sysmex UD-10 is described as a device that "locates and presents particles and cellular elements based on size ranges. The images are displayed for review and classification by a qualified clinical laboratory technologist." This indicates that the device requires human-in-the-loop for classification and is not a standalone diagnostic algorithm. Its performance is implicitly tied to how well technologists can use the displayed images. The "Overall Agreement" metrics in the studies reflect the performance of the system (device + technologist).

7. Type of Ground Truth Used

Reproducibility Study:

• Ground truth: Expected results from commercially available MAS® UA control material (Level 1 and Level 2).

Repeatability Study:

• Ground truth: Reference results provided by screening samples with the Sysmex UF-1000i urine analyzer (K070910).

Carryover Study:

• Ground truth: Determined by Sysmex UF-1000i results for high and low concentration samples.

Method Comparison Study:

• Ground truth: For the initial comparison, manual microscopy was considered the comparative method. For the referee comparison, the Sysmex UF-1000i (K070910) was used as the referee method to evaluate agreement between UD-10 and manual microscopy.

8. Sample Size for the Training Set

The document is a 510(k) summary for a medical device that captures and displays images for human review, not an AI/ML algorithm that requires a "training set" in the conventional sense of machine learning model development. Therefore, there is no mention of a training set sample size. The device uses size ranges to sort images, indicating a rule-based or conventional image processing approach rather than a complex AI model that learns from diverse training data.

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

As noted above, this device does not appear to involve a machine learning training set in the way a typical AI algorithm would. Thus, this question is not applicable based on the provided information.

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The Sysmex® UF-5000 Fully Automated Urine Particle Analyzer is an automated urine particle analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The Sysmex® UF-5000 Fully Automated Urine Particle Analyzer analyzes the following parameters in urine samples: RBC, WBC, Epithelial cells, Cast, Bacteria and flags the presence of the following: Pathologic Cast, Crystals, Sperm, Yeast like cell and Mucus.

The Sysmex® UF-5000 Fully Automated Urine Particle Analyzer is an automated urine particle analyzer that is used in the clinical laboratory to analyze formed elements in urine samples quantitatively and flag for the presence of particles/cells in the sample. It provides screening of abnormal samples, as well as automation and better efficiency in the laboratory. The analyzer reports analysis results on five enumerated parameters in urine: RBC (Red Blood Cells), WBC (White Blood Cells), EC (Epithelial Cells), CAST and BACT (Bacteria). It also reports flagging information on the following parameters in urine: Pathologic Cast; Crystal; Sperm; Yeast like cell; and Mucus. This flagging information alerts the operator for the need of further testing and/or review.

The Sysmex® UF-5000 Fully Automated Urine Particle Analyzer is a dedicated system for the analysis of microscopic formed elements in urine and uses a Microsoft® Windows Operating System. The analyzer consists of the following units: (1) Main Unit which aspirates, dilutes, mixes and analyzes urine samples and processes data from the main unit and provides the operator interface with the system; (2) Sampler Unit which supplies samples to the main unit automatically; and (3) Pneumatic Unit which supplies pressure and vacuum to the main unit.

The analyzer uses five reagents-UF-CELLSHEATH (sheath reagent), UF-CELLPACK CR and UF-CELLPACK SF (diluents) and UF-Fluorocell CR and UF-Fluorocell SF (both stains). The quality control material is UF-CONTROL.

The provided text describes the performance data and conclusions for the Sysmex® UF-5000 Fully Automated Urine Particle Analyzer, seeking to prove its substantial equivalence to the predicate device, the Sysmex® UF-1000i. This is a submission for a 510(k) premarket notification, which focuses on demonstrating equivalence rather than establishing novel claims.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based only on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not present a formal table of specific acceptance criteria (e.g., target accuracy percentages, precision ranges) that the Sysmex® UF-5000 had to meet. Instead, it describes general categories of performance testing conducted to demonstrate "equivalent performance" to the predicate device:

2. Sample size used for the test set and the data provenance

The document does not explicitly state the sample size used for the test set. It mentions "Clinical and analytical validation testing" and "Method Comparison" but provides no numbers of samples or patients.

Regarding data provenance: The document identifies Sysmex America Inc. (Illinois, USA) as the submitter. While it doesn't explicitly state the country of origin for the clinical samples, it's highly likely to be the USA, given the submitter's location and the FDA submission context. The study is implicitly prospective in nature, as it involves newly conducted validation testing for a new device to demonstrate its performance characteristics.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document does not provide any information about the number or qualifications of experts used to establish ground truth for the test set. For a device like an automated cell counter, the "ground truth" for method comparison studies is typically established by comparing its results against a "gold standard" or reference method, which might be manual microscopy performed by trained laboratory professionals (medical technologists, clinical pathologists), or by comparing against the predicate device itself. However, the text does not elaborate on this.

4. Adjudication method for the test set

The document does not describe any adjudication method. Given that the device is an automated cell counter, the "ground truth" would likely be established through a reference laboratory method rather than a panel of human adjudicators in the way an imaging AI might use.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This type of study is more common for diagnostic imaging devices where human interpretation is a primary component of the diagnostic pathway. For an automated laboratory analyzer, the performance is assessed against reference methods and statistical agreement with the predicate.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Yes, the studies described are inherently "standalone" in the context of the device's operation. The Sysmex® UF-5000 Fully Automated Urine Particle Analyzer is an automated device designed to analyze urine samples and report parameters directly. The performance evaluation (LoB/LoD/LoQ, linearity, precision, carryover, method comparison) assesses the device's analytical performance on its own, without direct real-time human intervention in the analysis process itself. Human interpretation of the results (e.g., flagging information leading to further testing) is part of its intended use, but the analytical performance is standalone.

7. The type of ground truth used

The document implies that the ground truth for the performance studies, particularly "Method Comparison," would be established by comparing the Sysmex® UF-5000's results against those of the predicate device (Sysmex® UF-1000i) and/or other established laboratory reference methods for urine particle analysis. It does not explicitly state which ultimate ground truth was used (e.g., pathology, manual microscopy, or clinical outcomes data). For quantitative parameters like RBC and WBC counts in urine, the "ground truth" often refers to the accepted values obtained from a reference measurement method.

8. The sample size for the training set

This document describes a 510(k) submission for an automated laboratory instrument, not a machine learning or AI model in the modern sense that typically involves "training sets." The "algorithm" or measurement principles (flow cytometry, laser detection, specific reagents) are embedded in the device's design. Therefore, the concept of a "training set" as it applies to AI models is not relevant here, and no information on a training set sample size is provided.

9. How the ground truth for the training set was established

As explained above, the concept of a "training set" for the Sysmex® UF-5000 as an automated instrument is not applicable in the same way it would be for AI/ML algorithms. The device's operational parameters and internal algorithms are based on established scientific principles of flow cytometry and are likely refined during product development and engineering, rather than "trained" on a dataset in the AI sense.

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The XW-100 Automated Hematology Analyzer (XW-100) is a quantitative automated hematology analyzer intended for in vitro diagnostic use to classify and enumerate the following parameters for venous whole blood anticoagulated with K2/K3 EDTA: WBC, RBC, HGB, HCT, MCV, PLT, LYM%, Other WBC%, NEUT%, LYM#, Other WBC#, and NEUT#. It is not for use in diagnosing or monitoring patients with primary or secondary chronic hematologic diseases/ disorders, oncology patients, critically ill patients, or children under the age of 2.

The XW-100 Automated Hematology Analyzer is an electrical resistance type blood cell counter. This technology may be variously referred to as direct current (DC) or impedance. The analyzer uses a human whole blood specimen and produces results for 12 hematology parameters, including the basic complete blood count (CBC), 3 part white blood cell (WBC) differential, and MCV. The analyzer uses DC with hydrodynamic focusing for all parameters except hemoglobin, which is measured photometrically. The patient sample is aspirated, measured, diluted with diluent (and Lyse for WBC measurement), then fed into a transducer chamber by means of a hydrodynamic focusing nozzle. The transducer chamber has a minute hole, or aperture. Electrodes are mounted on both sides of the aperture chamber, through which flows the DC. Blood cells suspended in the diluted sample are injected through the aperture by the hydrodynamic focusing nozzle. The hydrodynamic focusing nozzle is positioned in front of the aperture and in line with the aperture's center. This method improves cell counting accuracy because all blood cells are separated from each other and can only pass through the aperture in 1 direction, 1 at a time. When a cell passes through the aperture, it causes a change in the DC resistance that is directly proportional to its size. These resistance changes are captured as electric pulses. The various blood cell counts are calculated by counting the pulses that occur in each cell size category. The analyzer then determines blood cell volume and identifies rare and pathological cells by creating and analyzing histograms of the various cell populations using their respective pulse heights. Hemoglobin is measured photometrically using a noncyanide methodology, which reduces the presence of hazardous materials in the analyzer waste stream. The quality controls that are used with the XW-100 CLIA Waived Automated Hematology Analyzer comprise XW QC CHECK, which contains stabilized red blood cell component(s), stabilized WBC component(s), and stabilized platelet component(s) in a preserving medium. XW QC CHECK components are packaged in glass vials with screw caps containing 2 mL. The vials are packaged in a welled vacuum- formed clamshell container. XW QC CHECK is stored at room temperature (15°C-25°C).

1. Table of Acceptance Criteria and Reported Device Performance:

The document refers to clinical performance data in K143577 and clinical field data and flex studies in CW170004. Without access to these referenced documents, a specific table of acceptance criteria and reported device performance cannot be generated. However, the summary states that "The performance data demonstrated substantial equivalence to the predicate device." This implies that the device met the performance requirements that allowed it to be deemed substantially equivalent to the predicate.

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

The available document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective) for the clinical performance data (K143577) or the clinical field data and flex studies (CW170004).

3. Number of Experts Used to Establish Ground Truth and Qualifications:

This information is not provided in the given document.

4. Adjudication Method for the Test Set:

This information is not provided in the given document.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not mentioned or described in the provided text. The device described, the XW-100 Automated Hematology Analyzer, is an automated diagnostic device, not one typically involving human readers for interpretation in the same way as, for example, an imaging diagnostic AI.

6. Standalone (Algorithm Only) Performance Study:

The information presented describes the automated hematology analyzer as a standalone device. Its performance data (referenced in K143577 and CW170004) would pertain to its direct measurements and classifications without direct human-in-the-loop intervention during the analysis process, as it is an "Automated Hematology Analyzer."

7. Type of Ground Truth Used:

While not explicitly stated for the referenced studies, for automated hematology analyzers, the common ground truth for evaluating performance would generally involve:

• Reference Methods: Comparison to established, highly accurate reference methods (e.g., manual microscopy and differential counts performed by highly experienced laboratory technologists) for cell enumeration and classification.
• Clinical Outcomes/Pathology: For certain parameters, correlation with patient pathology reports or clinical outcomes might also be used as a broader validation.

8. Sample Size for the Training Set:

The document does not provide information regarding a specific training set size. Automated hematology analyzers like the XW-100 are typically developed and calibrated using extensive internal datasets, but the details of these are not included here.

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

This information is not provided in the given document. For such devices, the ground truth for training data would typically be established through well-defined laboratory protocols, including manual differential counts by expert morphologists and correlation with other established diagnostic techniques.

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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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