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The UniCel DxH 800 Analyzer is a quantitative multi-parameter, automatology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UniCel DxH 800 Analyzer identifies and enumerates the parameters indicated below on the following sample types:

Whole Blood (Venous and Capillary) - WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, RDW-SD, PLT, MPV, NE %, NE#, LY%, LY#, MO%, MO#, EO%, BA%, BA#, NRBC%, NRBC%, RET%, RET#, MRV, IRF

Pre-Diluted Whole Blood (Venous and Capillary) - WBC, RBC, HGB, HCT, MCH, MCHC, RDW, RDW-SD, PLT, MPV

Body Fluids (cerebrospinal, serous and synovial) - TNC and RBC

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 DxH 800 System is a quantitative, automated hematology analyzer 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). The DxH 800 also includes the Monocyte Distribution Width (MDW) parameter shown to aid in the early detection of Sepsis in emergency room adult 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).

I am sorry, but the provided text does not contain detailed information about acceptance criteria for the Early Sepsis Indicator (MDW) application, nor does it describe a specific study that proves the device meets such criteria.

The 510(k) summary focuses on design changes to the UniCel DxH 800 Coulter Cellular Analysis System, primarily addressing a software update due to a previously identified issue with erroneously elevated platelet results. While the document mentions that the Early Sepsis Indicator application is part of the UniCel DxH 800 system, the performance testing section briefly lists "Carryover, Linearity, Precision, Method Comparison" as design performance verification analyses for the overall system, but it does not specify acceptance criteria or detailed results for the MDW parameter or the Early Sepsis Indicator application.

Therefore, I cannot provide the requested information from the given text.

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The UniCel® DxH 800 Analyzer is a quantitative multi-parameter, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories.

The UniCel® DxH 800 Analyzer identifies and enumerates the parameters indicated below on the following sample types:

Whole Blood (venous and capillary) - WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, RDW-SD, PLT, MPV, NE%, NE#, LY%, LY#, MO%, MO#, EO%, EO#, BA%, BA#, NRBC%, NRBC#, RET%, RET#, MRV, IRF

Pre-Diluted Whole Blood (venous and capillary) - WBC, RBC, HCT, MCV, MCH, MCHC, RDW, RDW-SD, PLT, MPV

Body Fluids (cerebrospinal, serous and synovial) - TNC and RBC

The DxH Slidemaker Stainer is a fully automated slide preparation and staining device that aspirates a whole-blood sample, smears a blood film on a clean microscope slide, and delivers a variety of fixatives, stains, buffers, and rinse solutions to that blood smear.

The DxH 800 and DxH SMS form a family of integrated and interactive modular products that are scalable to meet the specific laboratory workflow and workload needs. Currently these products are offered as stand-alone devices only.

DxH 800: The UniCel DxH 800 Analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UniCel DxH 800 Analyzer provides a Complete Blood Count (CBC), Leukocyte Five-part Differential (Diff), Reticulocyte (RET), Nucleated Red Blood Cell (NRBC) on whole blood, Total Nucleated Count (TNC) and Red Blood Cell Count (RBC) on Body Fluids (cerebrospinal, serous and synovial)

DxH SMS: The DxH Slidemaker Stainer is a fully automated slide preparation and staining device that aspirates a whole-blood sample, smears a blood film on a clean microscope slide, and delivers a variety of fixatives, stains, buffers, and rinse solutions to that blood smear.

The upgrade of these devices with software v3.0 will allow for these stand-alone devices to be configured into five workcell configurations through physical and virtual connections. Physically, the instruments are connected via hardware and the virtual connection is accomplished by means of the new control system software that provides integrated process control, data consolidation and sample transport to the various instruments in the workcell in order to facilitate and improve laboratory efficiency. This will yield a total of seven product configurations, including:

Stand-alone DxH 800 with software v3.0
Stand-alone DxH SMS with software v3.0
Five customizable workcell configurations comprised of DxH 800 and DxH SMS with software v3.0
DxH 801 - one DxH 800 + one DxH SMS
DxH 1600 two DxH 800
DxH 1601 two DxH 800 + one DxH SMS
DxH 2400 three DxH 800
DxH 2401 three DxH 800 + one DxH SMS

These workcell configurations allow for increased system efficiencies through workload balancing between available instruments within the workcell, and automated pass through processing of selected slide preparation and stain test orders.

This document describes the 510(k) premarket notification for the UniCel DxH 800 and DxH Slidemaker Stainer Coulter Cellular Analysis System, specifically referring to the update to software version 3.0.

Here's an analysis of the acceptance criteria and supporting studies, as per your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document presents performance characteristics and testing results rather than explicit "acceptance criteria" in a numerical or categorical format within a single table. It states that the device "meets the performance requirements." Based on the studies summarized, the implied acceptance criterion for each study is that the device demonstrates compliance with the respective performance requirement.

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

The document does not explicitly state the sample sizes used for the various performance tests (e.g., for measurement procedure comparison, imprecision, linearity, carryover, slide quality).

The data provenance is not explicitly detailed regarding country of origin or whether it was retrospective or prospective. However, the studies are described as "Verification" or "Evaluation" and refer to "patient samples," implying that the testing was conducted with biological samples in a laboratory setting. The predicate device (v2.0) was manufactured by Beckman Coulter, suggesting the studies would likely be linked to their research and development activities.

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. For the DxH SMS, the reference method is "Manually prepared blood films per the manual wedge-pull film technique as described in CLSI H20-A2," which implies human expert review, but the number and qualifications of these experts are not specified.

4. Adjudication Method for the Test Set

The document does not mention any adjudication method for the test set. For a device like an automated differential cell counter and slidemaker/stainer, ground truth is typically established against established manual methods and/or expert morphological review, but the specific adjudication process is not detailed.

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

The document describes an automated hematology analyzer and slidemaker/stainer, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC comparative effectiveness study involving human readers' improvement with AI assistance is not applicable and was not performed or reported. The studies evaluate the device's technical performance against a predicate device or established manual methods.

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

Yes, the studies presented are for the standalone performance of the UniCel DxH 800 and DxH SMS devices. The document focuses on the device's ability to accurately enumerate and identify blood parameters and prepare quality slides directly, without an explicit human-in-the-loop component being evaluated for its performance metrics. The performance characteristics compare the device's outputs to a predicate device (DxH 800 v2.0) or a manual reference method (for DxH SMS), assessing the algorithm's accuracy in a standalone capacity.

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

The type of ground truth used varies by the study:

• For the UniCel DxH 800 (measuring parameters like WBC, RBC, etc.): The ground truth for bias evaluation was established by comparison against a predicate device (UniCel DxH 800 Software 2.0), which itself would have been previously validated against established methods. The guidance documents (CLSI H26-A2, EP9-A3) also imply accepted reference measurement procedures.
• For the UniCel DxH Slidemaker Stainer (DxH SMS): The ground truth for slide quality was established against the manual wedge-pull film technique as described in CLSI H20-A2. This CLSI standard is likely considered the gold standard for manual blood film preparation, implying that the "ground truth" for slide quality aligns with the criteria outlined in that standard, which would typically be assessed by trained laboratory professionals.

8. The Sample Size for the Training Set

The document does not provide information regarding a separate "training set" or its sample size. This type of regulatory submission (510(k)) for an automated hematology analyzer typically focuses on verification and validation studies on a test set, demonstrating equivalence to an existing device or method. If machine learning was used in the development of the algorithms, information about the training set might be proprietary or not deemed necessary for this level of regulatory submission, especially if the changes are primarily integration and software.

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

As no information on a specific "training set" is provided, how its ground truth was established is not detailed in this document.

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The UniCel® DxH 800 COULTER® Analyzer is a quantitative multi-parameter, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories.

The UniCel® DxH 800 COULTER® Analyzer identifies and enumerates the parameters indicated below on the following sample types:

• Whole Blood (Venous and Capillary)
  • o WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, RDW-SD, PLT, MPV, NE%, NE#, LY%, LY%, MO%, MO#, EO%, EO#, BA%, BA#, NRBC%, NRBC#, RET%, RET%, RET#, MRV, IRF
• 이 Pre-Diluted Whole Blood (Venous and Capillary)
  • WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, RDW-SD, o PLT, MPV
• Body Fluids (cerebrospinal, serous and synovial) ■ o TNC and RBC

The updated DxH 800 with software version 2.0, the subject of this submission, uses the same principles of operation, reagents, controls and calibrators as the original cleared device.

The UniCel® DxH 800 COULTER® Cellular Analysis System (DxH 800) is intended for In Vitro Diagnostic Use in clinical laboratories. The DxH 800 System provides automated complete blood count, leukocyte differential, nucleated red blood cell (NRBC) enumeration and reticulocyte analysis as well as an automated method for enumeration of the Total Nucleated Cells (TNC) and Red Blood Cells (RBC) in body fluids.

The DxH 800 System is intended to separate patients with normal hematological parameters from patients who need additional studies of any of these parameters. These studies might include further measurements of cell size and platelet distribution, manual WBC differential or any other definitive test that helps diagnose the patient's condition.

The DxH 800 system is comprised of the analyzer, an optional floor stand, and a suite of analytical reagents, quality control and calibration reagents, and reagents for system cleaning.

Here's a breakdown of the acceptance criteria and study information for the Beckman Coulter UniCel® DxH 800 COULTER® Cellular Analysis System, based on the provided document:

Acceptance Criteria and Device Performance

The general acceptance criteria are that the updated DxH 800 system meets the performance requirements (within acceptance limits) for its claimed parameters, demonstrating comparability or equivalency to the predicate device and/or manual reference methods. Specific numerical acceptance limits are not provided in this summary, but the "510(k) Testing Summary" column indicates that the device met these unstated performance requirements.

Table of Acceptance Criteria (Generic) and Reported Device Performance

Study Details:

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

   • The document does not explicitly state specific sample sizes for each test set. It mentions "analysis of the data collected" for each performance study.
   • Data Provenance: The document does not explicitly state the country of origin. It refers to "patient samples" and "control materials." Given Beckman Coulter is based in Miami, Florida (USA), clinical studies are often conducted within the US or aligned with US regulatory standards. The CLSI (Clinical and Laboratory Standards Institute) standards cited are internationally recognized but a primary focus in the US. The studies are retrospective in the sense that the performance data for the updated DxH 800 is being compared to an existing predicate device (K081930), which would imply using comparable data sets or collecting new data for comparison. The document states, for clinical sensitivity and specificity, the comparison was made "analyzing the same data set" as the predicate, suggesting some retrospective analysis of existing data. However, the performance studies themselves likely involved prospective collection of samples for the updated device's testing.

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

   • The document explicitly mentions comparison to "manual reference results" for differential parameters and "manual chamber count" for body fluid parameters.
   • However, it does not specify the number of experts used or their qualifications (e.g., "radiologist with 10 years of experience").
   • The CLSI H20-A2 standard ("Reference Leukocyte (WBC) Differential Count (Proportional) and Evaluation of Instrumental Methods") is cited, which typically outlines procedures for establishing manual differential counts, often involving trained morphologists or medical technologists.

3. Adjudication Method for the Test Set:

   • The document does not explicitly describe adjudication methods for the test set. For manual reference methods, standard practice often involves review by a trained expert, possibly with a second review in cases of discrepancy, but this is not detailed in the summary.

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

   • No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done in the context of human readers improving with AI vs. without AI assistance. This device is an automated hematology analyzer, not an AI-assisted diagnostic imaging device that typically involves human readers. The comparative studies focus on the device's performance against a predicate device or manual reference methods, not human reader performance.

5. Standalone Performance (Algorithm Only without Human-in-the-Loop):

   • Yes, the studies described are primarily standalone performance evaluations of the UniCel® DxH 800 system itself. This device is the algorithm, providing automated results for various hematologic parameters. The "human-in-the-loop" aspect exists in clinical practice (e.g., reviewing flagging results, performing manual differentials when indicated), but the performance studies focus on the automated system's accuracy, precision, and other analytical specifications. The "Clinical Sensitivity and Specificity" study for WBC differential flagging assesses the algorithm's ability to correctly identify cases needing further review, which can be seen as a measure of its standalone utility in a screening context.

6. Type of Ground Truth Used:

   • Expert Consensus/Manual Reference Methods: For differential parameters, "manual reference results" were used. For body fluid parameters, "manual chamber count" was the ground truth.
   • Predicate Device Data: For many parameters, the updated DxH 800 was compared against the "predicate device" (UniCel® DxH 800, K081930). This implies the predicate device's established performance served as a form of "ground truth" or a benchmark for equivalency.

7. Sample Size for the Training Set:

   • The document is a 510(k) summary for an update to an existing device (software version 2.0 of the DxH 800). The underlying principles (Coulter Principle, VCSn technology) and reagents are the same as the predicate device. Therefore, a separate "training set" in the modern machine learning sense is not explicitly mentioned or likely relevant for this software update submission. The "algorithms using advanced mathematical methods for population differentiation and flagging" would have been developed and "trained" during the original device's development (K081930), and this submission focuses on demonstrating that the updated software maintains or improves performance.

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

   • As noted above, a distinct "training set" for the software update is not detailed. For the original device's algorithms, the ground truth would have been established through extensive studies comparing automated counts and differentiation with expert-reviewed manual microscopy (e.g., manual differential counts performed by experienced morphologists) and possibly other reference methods over a large and diverse set of patient samples. This process would involve adhering to standards like CLSI H20-A2, which describes the reference leukocyte differential count method.

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The UniCel® DxH 800 Analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UniCel® DxH 800 Analyzer provides:

• a Complete Blood Count (CBC), Leukocyte 5 Part Differential (Diff), Reticulocyte (Retic) and Nucleated Red Blood Cell (NRBC) on whole blood
• a Total Nucleated Count (TNC) and Red Cell Count (RBC) on Body Fluids (cerebrospinal, serous and synovial) (BF)

The UniCel® DxH 800 Coulter® Cellular Analysis System (DxH 800 System) is intended for In Vitro Diagnostic Use in clinical laboratories. The DxH 800 System provides automated complete blood count, leukocyte differential, NRBC enumeration and reticulocyte analysis as well as an automated method for enumeration of RBCs and TNCs in body fluids.
The purpose of the DxH 800 System is intended to separate the normal patient. with all normal system-generated parameters, from the patient who needs additional studies of any of these parameters. These studies might include further measurements of cell size and platelet distribution, manual WBC differential or any other definitive test that helps diagnose the patient's condition.
The instrument system is comprised of the analyzer and a suite of analytical reagents that allow for simultaneous quantitative determination of hematological parameters through the use of impedance, RF, flow cytometric light scatter, spectrophotometry, and supravital staining methodologies. Additional reagents provide system cleaning and quality control and calibration.

The provided text for the UniCel® DxH 800 Coulter® Cellular Analysis System (K081930) is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed study results with acceptance criteria.

Therefore, the information required to fully answer your request regarding acceptance criteria and the study proving the device meets them is not explicitly available in the provided document.

However, I can extract what is stated and highlight the missing information:

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

The document broadly states: "Accuracy, repeatability (precision), measuring (linearity) range and carryover studies were conducted and demonstrated acceptable performance per the manufacturer specifications."

Missing Information:

• Specific numerical acceptance criteria for accuracy, repeatability, linearity, and carryover for each parameter (e.g., WBC, RBC, Hgb, etc.).
• The actual reported performance values for each of these criteria.

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

Missing Information:

• Specific sample sizes used for accuracy, repeatability, linearity, and carryover studies.
• Data provenance (country of origin, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This device is an automated hematology analyzer, not an imaging device requiring expert interpretation for ground truth in the typical sense (like radiology). Ground truth for hematology analyzers is usually established by reference methods or validated manual counts.

Missing Information:

• Details on how ground truth was established for the performance studies (e.g., specific reference methods, manual microscopy, or comparison to predicate). If manual microscopy was used for differential counts, the number and qualifications of technicians would be relevant, but this is not mentioned.

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

Missing Information:

• Adjudication methods are not applicable nor mentioned for this type of device and performance testing.

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

Missing Information:

• MRMC studies are typically for medical imaging devices where human readers interpret cases. This is an automated laboratory analyzer, so an MRMC study is not relevant and was not conducted or mentioned.

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

This device is a standalone automated analyzer. Its performance data (accuracy, precision, linearity) inherently represent its standalone performance, as it is designed to replace or assist manual methods in laboratories. The summary refers to "acceptable performance per the manufacturer specifications," implying standalone performance.

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

Missing Information:

• The document does not specify the type of ground truth (e.g., specific reference methods, manual counts, or comparison to predicate devices) used for the performance studies. For hematology parameters, ground truth is often established using established reference methods, manual microscopy, or comparisons to well-characterized predicate devices.

8. The sample size for the training set

The device is an automated hematology analyzer, not an AI/ML device that requires a "training set" in the common machine learning sense. Its algorithms are based on established physical principles (impedance, RF, flow cytometry, spectrophotometry) and pre-determined thresholds and calculations.

Missing Information:

• Not applicable in the context of this traditional automated laboratory device.

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

Missing Information:

• Not applicable as it's not an AI/ML device with a "training set."

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