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The Unicel DxH 800 Coulter Cellular Analysis System with Early Sepsis Indicator Application is the quantitative measurement of Monocyte Distribution Width (MDW). The Early Sepsis Indicator is intended for use with adult patients presenting to the emergency department, on whom a white cell differential test has been ordered.

MDW is measured from a (K2EDTA) whole-blood venous sample within 2 hours of collection. MDW values greater than 20.0 together with other laboratory findings and clinical information, aids in identifying patients with sepsis or at increased risk of developing sepsis within the first 12 hours of hospital admission.

MDW values greater than 20.0 should be interpreted in association with other clinical information and diagnostic testing, as a proportion of patients without sepsis may have an elevated MDW value at baseline.

MDW values less than or equal to 20.0 cannot rule out sepsis or the development of sepsis within 12 hours of hospital admission. The Early Sepsis Indicator should not be used as the sole basis to determine the absence of sepsis.

The predictive value of the Early Sepsis Indicator for identifying sepsis in patients with hematological abnormalities has not been established.

The Early Sepsis Indicator (ESI) requires the use of the UniCel DxH 800 Coulter Cellular Analysis System (DxH 800) and its reagents, controls and calibrators last cleared under 510(k) K140911.

The UniCel DxH 800 Coulter Cellular Analysis System contains a quantitative, automated hematology analyzer (DxH 800) designed for in vitro diagnostic use in screening patient populations by clinical laboratories. The system provides a Complete Blood Count (CBC), Leukocyte 5 Part Differential (Diff), Reticulocyte (Retic), Nucleated Red Blood Cell (NRBC) on whole blood, as well as, Total Nucleated Count (TNC), and Red Cell Count (RBC) on Body Fluids (cerebrospinal, serous and synovial). This submission adds a new parameter, Monocyte Distribution Width (MDW) to those mentioned above. This parameter has been shown to aid in the early detection of Sepsis in emergency room patients.

The system consists of two primary components, the workstation and the DxH 800 analyzer as shown in Figure 1. DxH 800 System Configuration. The primary function of the DxH 800 analyzer is to process samples and provide results to the workstation. The primary functions of the workstation are: user interface, system control, results processing and storage and external communications. The analyzer runs embedded code and the workstation runs Microsoft Windows 7 Operating System (OS).

Here's the breakdown of the acceptance criteria and study detailed in the provided document:

Acceptance Criteria and Device Performance for UniCel DxH 800 Cellular Analysis System with Early Sepsis Indicator Application

The device is intended for the quantitative measurement of Monocyte Distribution Width (MDW) to aid in identifying adult patients with sepsis or at increased risk of developing sepsis within the first 12 hours of hospital admission. The key acceptance criterion for clinical accuracy revolves around sensitivity and specificity at a specified MDW cut-off.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that the study demonstrated that an MDW cut-off of 20.0 units provided an optimum diagnostic ability by balancing the ability to detect positive patients (sensitivity) and negative patients (specificity), and thus this cut-off was selected. Detailed numerical values for sensitivity and specificity at this cut-off are not explicitly provided in the table, but the text assures they met the acceptance criteria.

2. Sample Size and Data Provenance for Test Set

• Sample Size: Not explicitly stated for the "test set" in a distinct way, but the "Clinical Accuracy" study states it was a "multi-center prospective cohort study."
• Data Provenance:
  • Country of Origin: Not specified in the provided text.
  • Retrospective or Prospective: Primarily prospective. The clinical accuracy study was a "multi-center prospective cohort study."

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

Note: The document mentions "clinical information and diagnostic testing" and "other laboratory findings" were used in conjunction with MDW values, implying expert judgment in establishing the ground truth for sepsis diagnosis.

4. Adjudication Method

• Adjudication Method: Not specified.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This device measures a quantitative biomarker (MDW) from a blood sample, not something interpreted by human readers from images or complex data.

6. Standalone (Algorithm Only) Performance

• Standalone Performance: Yes, the fundamental performance assessed is the standalone diagnostic ability of the MDW parameter as an aid in identifying sepsis. The clinical accuracy study directly evaluated the MDW parameter's performance in detecting sepsis.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth for sepsis diagnosis was established based on "other laboratory findings and clinical information" and "diagnostic testing." This suggests a comprehensive clinical diagnosis of sepsis, likely involving a combination of clinical assessment, laboratory parameters (beyond MDW), and potentially culture results or other confirmatory tests, as determined by clinicians.

8. Sample Size for Training Set

• Sample Size for Training Set: Not explicitly stated as a separate "training set" in the context of machine learning model development. The document focuses on the validation of the MDW parameter and its cut-off.

Note: The MDW parameter itself is a quantitative measurement derived from hematology analyzer data, not a machine learning model that would typically have a distinct training set in the conventional sense. The "training" or development of the algorithm to calculate MDW would have occurred prior to this validation study, but details are not provided here.

9. How Ground Truth for Training Set Was Established

• How Ground Truth for Training Set Was Established: Not specified, as a distinct training set for a machine learning model is not explicitly mentioned or implied for the MDW parameter's development in this document. The MDW value is a quantitative measurement from the analyzer, not a diagnosis itself.

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The COULTER LH 750 Hematology Analyzer is a quantitative, automated hematology analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories. The COULTER LH 750 Hematology Analyzer provides automated Reticulocyte analysis and enumeration of nucleated red blood cells (NRBCs) as well as an automated method for enumeration of RBCs and WBCs in body fluids.

The product is an automated hematology analyzer capable of supplying a complete blood cell analysis and includes a differential leukocyte cell count. The product also provides automated reticulocyte analysis and enumeration of nucleated red blood cells (NRBCs) as well as an automated method for enumeration of RBCs and WBCs in body fluids. The COULTER LH 750 Hematology Analyzer utilizes the Coulter Principle for enumerating and sizing blood cells, automatic diluting and mixing for sample processing and a single beam photometer for hemoglobinometry. It uses COULTER VCS (volume, conductivity, light scatter) technology for WBC Differential analysis and classification and reticulocyte analysis. The analyzer uses a reagent system consisting of an isotonic diluent, lytic reagents to lyse the red cells without significantly affecting the white cells and an instrument cleaner. Additionally, all systems include reagents used for reticulocyte staining and analysis. For body fluids analysis, the specimen is aspirated into the LH 750 Analyzer via the manual mode and is diluted in separate WBC and RBC baths. The Coulter Method of counting cells is used to detect and measure changes in electrical resistance when a cell, suspended in a conductive diluent, passes through a small aperture.

The provided document K061574, a 510(k) summary for the COULTER® LH 750 Hematology Analyzer, is primarily a notification of a modification to the device, specifically a revised MCV accuracy specification. It does not contain detailed information about a comprehensive study proving the device meets acceptance criteria for all its listed functions (e.g., differential leukocyte count, reticulocyte analysis, NRBC enumeration, body fluid analysis).

The document mentions that the modification relates to the "draft labeling submitted in the original Premarket notification (K011342) to reflect a revised MCV accuracy specification." This implies that the initial and comprehensive studies would have been part of the K011342 and K030606 submissions, which are referenced as legally marketed predicate devices.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, ground truth, experts, and MRMC studies are not available in the provided text. The following table and explanations reflect the information that can be extracted from the given document, focusing on the modification rather than a complete re-evaluation of the entire device.

Acceptance Criteria and Reported Device Performance (Focused on MCV Accuracy Specification)

Missing Information:

• The actual numerical value of the original MCV accuracy specification.
• The actual numerical value of the revised MCV accuracy specification.
• The specific data and statistical analysis demonstrating that the device meets the revised MCV accuracy specification.

Study Information (Based on the available document)

Given the nature of the document (a 510(k) for a revised MCV accuracy specification), the details of a full study often found in original 510(k) submissions are not present. The focus here is on what can be inferred about the change rather than a complete de novo study validation.

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: Not specified in this document. Information on the number of samples used to validate the revised MCV accuracy is absent.
   • Data Provenance: Not specified. It's likely that data would be from internal Beckman Coulter studies, but details on country of origin or whether it was retrospective or prospective are not provided for this specific modification. For the original device, it would have been part of K011342 and K030606.

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

   • Number of Experts: Not specified.
   • Qualifications of Experts: Not specified. Given the nature of a hematology analyzer, ground truth for MCV would typically involve reference methods and quality controls, potentially with expert oversight for sample preparation and analysis.

3. Adjudication method for the test set:

   • Not specified. This is typically relevant for subjective assessments (e.g., image review), which MCV measurement is not. For quantitative measurements like MCV, validation usually involves comparison to a reference method or validated control materials.

4. 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 imaging tool with human readers. Therefore, an MRMC study and effects on human reader improvement are not relevant here.

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

   • The COULTER® LH 750 Hematology Analyzer is an automated device, meaning its primary function is standalone performance (algorithm only). The document describes it as "a quantitative, automated hematology analyzer."
   • The modifications to its MCV accuracy specification would inherently relate to its standalone performance.

6. The type of ground truth used:

   • Likely Reference Methods and Calibrated Controls: For MCV, ground truth would typically be established using validated reference methods (e.g., manual packed cell volume, or highly calibrated reference instruments) and internationally recognized hematology calibrators and internal quality control materials (some of which are mentioned as qualified reagents, such as COULTER S-CAL® Hematology Calibrator).

7. The sample size for the training set:

   • Not applicable/Not specified for this modification. This document pertains to a specification revision for an existing, already-marketed device. It's not a de novo algorithm development that would explicitly describe a "training set" in the context of machine learning. The device's underlying principles (Coulter Principle, VCS technology) are well-established. Any "training" or calibration would have occurred during the original device development (K011342) and subsequent routine calibration of individual instruments.

8. How the ground truth for the training set was established:

   • Not applicable/Not specified for this modification. As above, the concept of a training set in the AI/ML sense isn't directly applicable here. For the original development, ground truth for calibration would have been established using reference methods and calibrated materials.

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The COULTER® LH 750 Hematology Analyzer is a quantitative, automated hematology Analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories. The COULTER® LH 750 Hematology Analyzer also provides automated Reticulocyte analysis and enumeration of nucleated red blood cells (NRBCs) in whole blood and white blood cells (WBCs) and red blood cells (RBCs) in body fluids.

The LH 700 Series Body Fluid Application is a procedure for obtaining in vitro quantitative determinations of leukocytes (WBC) and erythrocytes (RBC) in cerebrospinal fluid, serous fluids, and synovial fluid, using a COULTER LH 700 Series Hematology Analyzer.

The product is an automated hematology analyzer capable of supplying a complete blood cell analysis and includes a differential leukocyte cell count. The product also provides automated reticulocyte analysis, enumeration of nucleated red blood cells (NRBCs) in whole blood and leukocytes (WBC) and erythrocytes (RBC) in cerebrospinal fluid, serous fluids, and synovial fluid.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the COULTER® LH 750 Hematology Analyzer's body fluids application:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes a modification to the existing COULTER® LH 750 Hematology Analyzer, specifically related to the stability of synovial and serous fluid samples. It doesn't detail the full acceptance criteria for the original device's general performance (e.g., accuracy, precision for all blood cell analysis), but rather focuses on the extended sample stability for specific fluid types.

Therefore, the table below reflects the specific acceptance criteria and reported performance relevant to this modification.

Note: The document states: "...to indicate a sample stability of eight (8) hours for synovial fluid analysis (rather than 1 hour) and eight (8) hours for serous fluid analysis (rather than 24 hours) to reflect actual validated performance." This implies that for serous fluid, while the proposed labeling change was from 24 hours to 8 hours, the new validated performance is 8 hours. This isn't an improvement in stability for serous fluids compared to the prior claim, but rather a correction to reflect actual validated performance, which now matches synovial fluid.

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

The document does not explicitly state the sample size used for the validation study that established the new sample stability times.

It also does not directly specify the provenance (country of origin, retrospective/prospective) of the data. However, as it's an FDA submission for a device marketed in the US, it's highly probable the data was generated within the US or under US regulatory guidelines. Given the context of "actual validated performance," it implies a prospective validation study was conducted to determine these new stability parameters.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

The document does not mention the use of experts to establish ground truth in the context of this sample stability study. This type of validation typically involves laboratory experiments comparing measurements taken at different time points, rather than subjective expert interpretation of results. The "ground truth" would be objective measurements from fresh samples. If clinicians were involved, it would likely be for reviewing the clinical implications, not for establishing the instrument's analytical performance on stability.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method. Adjudication is usually relevant when multiple experts provide subjective assessments that need to be reconciled. In a study validating sample stability of a hematology analyzer, the "ground truth" (i.e., whether a sample's parameters changed significantly over time) is determined by quantitative measurements and statistical analysis, not by expert consensus or adjudication.

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

No MRMC comparative effectiveness study was done, nor is it applicable here. This submission is for a modification to an automated hematology analyzer, not an AI-powered diagnostic imaging tool or a system involving human interpretation with AI assistance. The device fully automates the analysis.

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

The entire operation of the COULTER® LH 750 Hematology Analyzer for cell counting and differentiation is standalone (algorithm only without human-in-the-loop performance). The device is the algorithm and analytical system; human interaction is for sample loading, maintenance, and result interpretation, but not for the primary measurement process itself. The modification discussed here (sample stability) directly pertains to the standalone performance of the analyzer with respect to sample integrity over time.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the sample stability study, the ground truth would be established through quantitative laboratory measurements on fresh samples and samples stored for different durations. The "ground truth" for a stable sample is that its measured parameters (e.g., WBC, RBC counts) do not significantly deviate from the initial measurement taken at time zero, within pre-defined analytical variation limits. This is an objective, measurement-based ground truth, not dependent on expert consensus or pathology in the conventional sense.

8. The Sample Size for the Training Set

The document does not mention a "training set" in the context of this sample stability modification. Hematology analyzers, especially those based on electrical impedance (Coulter Principle) and VCS technology, are generally rule-based or empirically developed, not typically "trained" using machine learning in the way an AI algorithm for image recognition would be. The validation described is about confirming the analytical stability of samples over time when processed by the existing device software and hardware.

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

As there is no mention of a training set for this specific modification and device type, this question is not applicable. The device's core functionality and its initial ground truth for cell identification and counting would have been established through extensive analytical validation against reference methods (e.g., manual microscopy, other established technologies) during its original development. This particular submission concerns a change in labeling claim based on new validation data regarding sample stability.

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The COULTER® LH 750 Hematology Analyzer is a quantitative, automated hematology Analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories. The COULTER® LH 750 Hematology Analyzer also provides automated Reticulocyte analysis and enumeration of nucleated red blood cells (NRBCs).

The product is an automated hematology analyzer capable of supplying a complete blood cell analysis and includes a differential leukocyte cell count. The product also provides automated reticulocyte analysis and enumeration of nucleated red blood cells (NRBCs). The COULTER LH 750 Hematology Analyzer with Version 2A software has the same technological characteristics and is substantially equivalent to the COULTER LH 750 Hematology Analyzer with Version 1A software. Both devices utilize the Coulter Principle for enumerating and sizing blood cells, automatic diluting and mixing for sample processing and a single beam photometer for hemoglobinometry. They use COULTER VCS (volume. conductivity, light scatter) technology for WBC Differential analysis and classification and reticulocyte analysis. The analyzers use a reagent system consisting of an isotonic diluent. lytic reagents to lyse the red cells without significantly affecting the white cells and an instrument cleaner. Additionally, all systems include reagents used for reticulocyte staining and analysis.

The provided text is limited and primarily focuses on the regulatory information, device description, and indications for use of the COULTER® LH 750 Hematology Analyzer with Version 2A Software. It explicitly states that this submission is a "Summary of Safety and Effectiveness," usually followed by a more detailed report or study.

Based on the provided text, a comprehensive acceptance criteria table and the study to prove it cannot be fully constructed because the detailed study results and specific acceptance criteria values are not included. The document acts as a 510(k) submission summary, indicating substantial equivalence to a predicate device, rather than a full study report with detailed performance metrics against predefined acceptance criteria.

However, I can extract the available information and highlight what is missing based on your request.

Acceptance Criteria and Device Performance

Due to the lack of specific performance data and predefined acceptance criteria in the provided text, this table will show what the document claims the device does (performance characteristics) and what would typically be expected as acceptance criteria for such a device.

Study Details (Based on available information in the document)

Given the nature of a 510(k) for a software/minor hardware update to an existing device, the "study" described is primarily focused on demonstrating substantial equivalence to the predicate device. The provided text is a summary and therefore lacks the granular detail of a full study report.

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

   • Sample Size: Not specified in the provided text.
   • Data Provenance: Not specified. It's common for such studies to involve samples from clinical laboratories, potentially across various demographics, but this information is absent here. The submission is from Beckman Coulter, Inc., Miami, FL, USA, suggesting the primary regulatory interaction and potentially the core development location.
   • Retrospective or Prospective: Not specified.

2. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

   • Not specified. For automated differential cell counters, ground truth is typically established through manual microscopic review by trained technologists or hematopathologists.

3. Adjudication Method for the Test Set:

   • Not specified.

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

   • No, an MRMC comparative effectiveness study is not explicitly mentioned or described. This type of study is more common for diagnostic imaging AI where human interpretation (readers) is a key part of the workflow. For an automated hematology analyzer, the focus is on the device's analytical performance (accuracy, precision, correlation to a reference method, or the predicate device), not typically on how it "improves" human reader performance in a diagnostic read, as the device itself provides the result.

5. Standalone (Algorithm Only) Performance Study:

   • Yes, implicitly. The device is an "automated differential cell counter" and provides "automated reticulocyte analysis and enumeration of nucleated red blood cells (NRBCs)." This means the algorithm performs these analyses without human intervention for each count. The "study" for a 510(k) of this nature would involve evaluating how well the device's automated counts agree with a reference method (e.g., manual microscopy) or with the predicate device. Specific standalone performance metrics (e.g., sensitivity, specificity, accuracy for flagging abnormal cells, or correlation coefficients for cell counts) are not provided in this summary.

6. Type of Ground Truth Used:

   • Not explicitly stated, but for hematology analyzers, typical ground truth involves:
     • Manual microscopy (expert review): For cell differentials, morphology, and difficult-to-classify cells.
     • Reference methods: For precise cell counts (e.g., flow cytometry for certain subpopulations or highly calibrated manual counts).
     • Predicate device results: For demonstrating substantial equivalence, direct comparison to the previous version's results is critical.

7. Sample Size for the Training Set:

   • The term "training set" is not mentioned, as this document describes a conventional medical device modification, not necessarily an AI/machine learning model in the modern sense that requires a distinct training phase. If the software improvements involved algorithmic adjustments, it implies development and testing data, but no specific "training set" size is provided.

8. How the Ground Truth for the Training Set was Established:

   • Not applicable as "training set" for an AI model is not described. For general software development and validation, ground truth would typically be established by established laboratory methods, manual review, or comparison to existing validated systems.

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