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The GloCyte Automated Cell Counter System is intended for use by trained healthcare professionals in clinical laboratories to provide quantitation of fluorescence labeled total nucleated cells and erythrocytes in cerebrospinal fluid collected from adult and pediatric patients.

The GloCyte Low and High Level Controls are assayed hematology controls designed to monitor the performance of the GloCyte Automated Cell Counter System. Assayed parameters include total nucleated cells and erythrocytes.

The GloCyte® Automated Cell Counter System is an automated cell counter that concentrates and enumerates total nucleated cells (TNCs) and red blood cells (RBCs) using fluorescent microscopy and digital image analysis principles. The test method uses one of two reagents to stain TNCs (propidium iodide with detergent) or RBCs (fluorochrome labeled anti- human RBC antibody in buffer with stabilizers), and a digital imaging system to count the cells. The image is captured by a digital CCD camera, and the fluorescent stained cells are counted via digital image processing.

The GloCyte® Automated Cell Counter System includes the Instrument, Computer (hardware & software), Vacuum Station, Sample Preparation Tray, Barcode Reader, Pipettes (10 and 30 µL), Test Cartridge, TNC and RBC Reagents, Low and High Level Controls.

Here's an analysis of the provided text regarding the GloCyte® Automated Cell Counter System, focusing on acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in a dedicated table. However, it implicitly defines successful performance by stating that "Results were shown to meet acceptance criteria" for accuracy and "The results of the repeatability study met acceptance criteria." The reproducibility study also "met acceptance criteria." Based on the reported data, the implicit acceptance criteria would relate to achieving results within the stated ranges, slopes, intercepts, and CVs.

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

• Accuracy Study (Hemocytometer vs. GloCyte):
  • TNC Pediatric: 129 samples
  • TNC Adult: 223 samples
  • RBC Pediatric: 196 samples
  • RBC Adult: 267 samples
  • Data Provenance: "clinical sites and in-house using clinical and contrived CSF specimens." This indicates a mix of prospective (clinical) and possibly retrospective (clinical) or laboratory-prepared (contrived) data. The country of origin is not specified but implicitly US, given the FDA submission.
• Repeatability Study:
  • TNC: 26 samples
  • RBC: 29 samples
  • Data Provenance: "three clinical sites and in-house using clinical and manipulated CSF specimens as well as GloCyte® Low and High Level Controls." Similar to accuracy, a mix of data types and locations.
• Precision/Reproducibility Study:
  • Each TNC and RBC level (Low/High) had 480 measurements (likely 2 operators * 2 measurements/day * 20 days * 3 sites).
  • Data Provenance: "three clinical sites," using GloCyte® Low and High Level Controls.
• Linearity Study:
  • Used "Contrived RBC and TNC CSF samples, created by dilution of human blood cells into blank CSF." Tested on three GloCyte® Automated Cell Counter Systems.
• Determination of LoB, LoD, LoQ:
  • No specific sample size mentioned, but studies were conducted "according to CLSI EP17-A2."
• Interfering Substances:
  • No specific sample size mentioned for each interferent, but "Interference testing was conducted."

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

The document does not specify the number or qualifications of experts used to establish ground truth for the test sets. For the accuracy study comparing GloCyte to Hemocytometer, the Hemocytometer results would serve as the comparative method. However, who performed the hemocytometer counts and their qualifications are not detailed.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method (e.g., 2+1, 3+1) for establishing the ground truth or resolving discrepancies in the test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not done. The device is an automated cell counter, which aims to replace or assist manual counting, but the study described focuses on the device's analytical performance against established methods, not human reader performance.

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

Yes, the studies described are standalone performance evaluations of the GloCyte® Automated Cell Counter System. The device is designed to be an automated system, and the reported accuracy, repeatability, precision, linearity, and reportable range studies all reflect the algorithm and instrument's performance without direct human intervention in the cell counting process for the test results.

7. The Type of Ground Truth Used

• For the accuracy study, the ground truth for TNC and RBC counts was established by comparison against Hemocytometer counts ("Hemocytometer vs. GloCyte TNC and RBC counts").
• For repeatability, precision/reproducibility, linearity, LoB, LoD, LoQ, and interfering substances, the ground truth was implicitly the expected value or reference method result derived from standard laboratory practices and controlled preparations, rather than expert consensus on individual cases or pathology reports. For example, linearity uses "true concentrations of the analyte" and "expected values."

8. The Sample Size for the Training Set

The document does not mention the sample size for a "training set." The GloCyte® Automated Cell Counter System uses digital image analysis principles to count cells. While such systems are often developed using training data, this submission focuses on the validation or performance testing datasets. It does not provide details about model development or the data used to "train" its algorithms.

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

Since no training set is discussed or implied in the provided text, the method for establishing its ground truth is also not elaborated upon.

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The iQ 200 Urine Analyzer Body Fluids Module is an in-vitro diagnostic device used by an appropriately trained laboratory user to examine and count red blood cells and nucleated cells in cerebrospinal fluid, serous fluids and synovial fluid. This module is a capability added to the iQ®200 Urine Analyzer.

The iQ®200 Urine Analyzer Body Fluids Module for use with synovial fluid is an additional use for the iQ®200 Urine Analyzer (K022774 – cleared October 21, 2002). It is used by a competent human observer to examine and count red blood cells and nucleated cells in synovial fluid and is an added body fluid to the previously cleared iQ®200 Urine Analyzer Body Fluids Module cerebrospinal and serous fluids (K050235 -Cleared March 23, 2005).

The provided text describes the 510(k) submission for the iQ® 200 Urine Analyzer Body Fluids Module with the addition of Synovial Fluid capability. It compares the device to a predicate device, the Sysmex® XT-4000i. However, the document does not provide a table of acceptance criteria or the specific performance data against those criteria. It states that "Clinical trial performance data demonstrated that the Synovial Fluid parameter on the iQ®200 Urine Analyzer Body Fluids Module is substantially equivalent to its predicates," and that "Data consisting of Accuracy, Precision, Linearity and Carryover was collected to show performance to the manufacturer's specification for the Body Fluid mode." However, these specific data points and the defined acceptance criteria are not included in the provided text.

Therefore, I can only address parts of your request based on the available information.

Summary of Available Information:

The iQ® 200 Urine Analyzer Body Fluids Module, with the new Synovial Fluid parameter, is an in-vitro diagnostic device used by trained laboratory users to examine and count red blood cells and nucleated cells in synovial fluid (along with cerebrospinal and serous fluids). It operates by adding hyaluronidase to the specimen, preparing two aliquots (one diluted, one lysed), capturing particle images as the sample flows past a microscope objective, ordering images by size into categories, and allowing a human observer to change machine assignments before re-computing and reporting concentrations.

The device's substantial equivalence to the Sysmex® XT-4000i (K091313) is claimed based on similarities in intended use, specimen collection (K2EDTA for synovial fluid), and the fact that both devices collect data on Accuracy, Precision, Linearity, and Carryover to demonstrate performance to manufacturer's specifications.

Information NOT available in the provided text:

• Specific Acceptance Criteria: The document mentions that performance data was collected "to show performance to the manufacturer's specification," but it does not specify what those specifications or acceptance criteria are (e.g., minimum accuracy percentages, precision ranges, linearity R-squared values, etc.).
• Reported Device Performance (against specific criteria): While the document states that clinical trial data "demonstrated substantial equivalence," the actual performance values for Accuracy, Precision, Linearity, and Carryover for the iQ® 200 Synovial Fluid module are not provided.
• Sample size used for the test set and data provenance: The document mentions "clinical trial performance data" and "Data consisting of Accuracy, Precision, Linearity and Carryover was collected," but it does not specify the sample size of the test set, the country of origin of the data, or whether it was retrospective or prospective.
• Number of experts and their qualifications for ground truth: This information is not provided.
• Adjudication method for the test set: This information is not provided.
• Multi Reader Multi Case (MRMC) comparative effectiveness study: The document does not describe an MRMC study. The device is used by a "competent human observer" who "may change machine assignments," indicating a human-in-the-loop process, but no comparative effectiveness study with and without AI assistance is described.
• Standalone (algorithm-only) performance: The device description clearly states that a "competent human observer may change machine assignments, after which particle concentrations are recomputed and reported," indicating it's not a standalone device. Therefore, standalone performance data would not be applicable or provided.
• Type of ground truth used: Given the context of a cell counter, it's highly likely that ground truth for performance studies would be established by manual microscopy with expert review, but this is not explicitly stated in the document.
• Sample size for the training set: The document does not mention any training set for an algorithm, as it describes a device that captures images and categorizes them, with human oversight. This suggests a more rule-based or image processing approach rather than a machine learning model requiring a distinct training set.
• How the ground truth for the training set was established: As no training set is described, this information is not applicable.

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The HemoCue WBC system is indicated for use for quantitative determination of white blood cell (WBC) count in capillary or venous whole blood. The HemoCue WBC system is for In Vitro Diagnostic use only. The HemoCue WBC Analyzer is only to be used with HemoCue WBC Microcuvettes. The HemoCue WBC system is indicated for use in clinical laboratories and for point-of-care settings.

The system consists of the HemoCue WBC Analyzer together with specially designed microcuvettes, the HemoCue WBC Microcuvettes. The microcuvette serves both as a sample container and a reaction chamber. A blood sample of approximately 10 uL is drawn into the cavity by capillary action. A hemolysing agent lyses the red cells in the microcuvette and a staining agent colors the white blood cells. An image is taken of the stained white blood cells and the number of cells is counted by image analysis. The result is presented within 3 minutes on the analyzer's display. The system reports results in the measuring range 0.3 - 30.0 x107/L. The system is factory calibrated and needs no further calibration.

The HemoCue WBC Analyzer is a portable device. The main parts are the cuvette holder (in which the microcuvette is placed), the cuvette moving arm (brings the microcuvette into correct measuring position), a magnifying optic unit, a camera, image processing software, a display and a power adapter.

The HemoCue WBC Microcuvette is made of polystyrene plastic and contains saponin that hemolyzes the red blood cells, methylene blue that stains the white blood cells and nonactive reagents. A blood sample of approximately 10 µL is drawn into the cavity by capillary action. The microcuvette serves as a sample container and a reaction chamber. No dilution of the sample is required.

The provided text for HemoCue WBC System (K071652) is a 510(k) summary and approval letter, which serves to establish substantial equivalence to predicate devices rather than fully detailing acceptance criteria and studies demonstrating performance. The document states that "Studies were conducted in-house, in clinical laboratory settings and point of care settings to demonstrate the performance with intended specifications of the HemoCue WBC system and to validate that the intended user can easily operate the system and obtain results as expected." However, it does not provide specific details on the acceptance criteria, reported performance, or the methodologies of these studies.

Therefore, much of the requested information cannot be definitively extracted from the provided text.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

This information is not explicitly provided in the given text. While it states that studies were conducted to "demonstrate the performance with intended specifications," it does not list these specifications or the corresponding results in a table format or any other detailed manner.

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

This information is not explicitly provided. The text mentions "in-house, in clinical laboratory settings and point of care settings" for studies but does not specify sample sizes or data provenance (country, 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 information is not provided. The text describes the device's technical characteristics and its indications for use, but it does not detail how ground truth was established for its validation studies.

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

This information is not provided.

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

This is not applicable as the HemoCue WBC System is an automated cell counter, not an AI-assisted diagnostic tool for human readers. The comparison is against predicate devices (Sysmex XS-1000i and manual light microscopy), not human readers.

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

Yes, the HemoCue WBC System is described as a "semi-automated device" that performs its analysis via "image analysis" and presents a result. Therefore, the performance described would inherently be standalone performance of the device's algorithm without a human in the loop for the actual WBC count determination. The process involves filling a microcuvette, placing it in the analyzer, and receiving a result.

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

This information is not explicitly provided. The comparison is made against a "Sysmex XS-system" and "manual light microscopic WBC method." It's highly probable that these predicate methods served as the ground truth or reference methods, but the text doesn't explicitly state how discrepancies were resolved or what constituted the ultimate "ground truth."

8. The sample size for the training set

This information is not provided.

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

This information is not provided. The text focuses on the device's operation and regulatory equivalence, not the specifics of its development and training data.

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The ADVIA® 2120 Nucleated Red Blood Cell (nRBC) method is intended to provide an in vitro diagnostic, quantitative determination of nucleated red blood cells in peripheral whole blood.

The technological and methodological principles of the ADVIA 2120 with Autoslide used for the quantitative measurement of blood cells in whole blood specimens will be used without change except for the addition of a new methodology to quantitate nucleated red blood cells and correct for white blood cells in peripheral whole blood.

The ADVIA 2120 Nucleated Red Blood Cell (nRBC) method is described below:
a) The ADVIA 2120 nRBC Analysis method uses histogram analysis routines to analyze the unstained region of the Peroxidase channel as well as an arithmetic algorithm that combines counts from the Peroxidase and Basophil/Lobularity channels to enumerate nRBCs.
b) The analysis corrects the White Blood Cell Count for the presence of nRBCs, as well as the WBC Differential. It reports the corrected WBC count and the corrected differential.

The new nRBC method will report the following Red Blood Cell Parameters-

1. % nucleated Red Blood Cells (% nRBC)
2. absolute nRBC (# of nRBC per microliter)

The provided text describes the ADVIA® 2120 with Autoslide and NRBC Method. However, it does not include detailed acceptance criteria or a study proving the device meets specific performance metrics in the format requested.

The text focuses on explaining the new functionality (nRBC analysis) and its technological characteristics compared to the predicate device. It also includes the FDA's 510(k) clearance letter, which confirms substantial equivalence but does not detail the underlying performance studies or acceptance criteria that led to that determination.

Therefore, I cannot provide the requested table or answer most of the questions because the information is not present in the provided document.

Here's what can be extracted based on the limited information:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated in the document.
• Reported Device Performance:
  • Reports "% nucleated Red Blood Cells (% nRBC)"
  • Reports "absolute nRBC (# of nRBC per microliter)"
  • Reports nRBC counts for whole blood samples with either 200 or more nRBC/uL, or with at least 2% nRBCs with a WBC count of at least 3,000/ uL.
  • Corrects the White Blood Cell Count for the presence of nRBCs.
  • Recalculates the WBC Differential, and recalculates %MN and %PMN.

2. Sample size used for the test set and the data provenance: Not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not provided.

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 is a standalone automated analyzer, not an AI-assisted reader system.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Yes, the device is described as an "Automated Hematology Analyzer," indicating standalone performance. The document states, "The ADVIA 2120 nRBC method uses histogram analysis routines... as well as an arithmetic algorithm that combines counts... to enumerate nRBCs." This describes the algorithm's standalone operation.

7. The type of ground truth used: The text mentions "nRBC counts are performed by manual methods that are well established as reference methods in clinical laboratories and consistent with NCCLS H-20A." This suggests that manual microscopy (per NCCLS H-20A guidelines) would have been used as the ground truth for validation, likely expert consensus through manual review.

8. The sample size for the training set: Not provided.

9. How the ground truth for the training set was established: Not explicitly stated, but likely through manual methods consistent with NCCLS H-20A, as referenced for "reference methods."

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The iQ 200 Urine Analyzer Body Fluids Module is an in-vitro diagnostic device used by a competent human observer to examine and count red blood cells and nucleated cells in cerebrospinal fluid and serous fluids.

Cerebrospinal fluid analysis is ordered by physicians to diagnose meningitis, intracranial hemorrhage, leukemias, malignancies and central nervous system disorders. Serous fluid analysis is ordered by physicians to diagnose infections, hemorrhages, malignancies and other disorders. Cell count determination is a part of these analyses.

The information produced by the iQ 200 Urine Analyzer Body Fluids Module concerning the cell concentrations in CSF and serous body fluids is ordered at the discretion of the physician, and is part of a larger body of laboratory and other test results available to assist the physician in health assessments or differential diagnoses. Cell count findings are always subject to judgment and interpretation by physicians relative to the patient's overall clinical presentation and history.

Two aliquots from each body fluid specimen sample are prepared. One aliquot is diluted in normal saline to provide a concentration in the linear range of the instrument. The second aliquot is treated with a lysing reagent to allow unambiguous identification of nucleated cells by eliminating RBC confusion. Particle images are captured and saved electronically as the sample flows past a microscope objective at a high speed, electronically concentrating particles. Particle images are then ordered by size into assigned categories on a video display. A competent human observer may change machine assignments, after which particle concentrations are recomputed and reported.

Here's a summary of the acceptance criteria and study details for the iQ® 200 Urine Analyzer Body Fluids Module, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The device's performance was compared to manual chamber counting. The acceptance criteria were not explicitly stated as distinct numerical thresholds, but rather implied by the statistical results (R2 values, slope within a CI, and non-significant intercepts) demonstrating substantial equivalence.

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

• RBC Test Set Sample Size: 304 samples
• Nucleated Cells Test Set Sample Size: 299 samples
• Data Provenance: Not explicitly stated (e.g., country of origin). The study is presented as a "Clinical Trial," implying prospective data collection, but it's not explicitly labeled as such or as retrospective.

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

The ground truth was established by "manual chamber counting" performed by a "competent human observer." The number of observers is not specified, nor are their specific qualifications (e.g., "radiologist with 10 years of experience").

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the test set. The comparison is between the device's performance and manual chamber counting.

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 done. The study compares the device's performance to "manual chamber counting," not to human readers' performance with and without AI assistance. The device itself still involves a "competent human observer" to potentially change machine assignments, but the primary performance study focuses on the instrument's accuracy compared to a manual method.

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

The device is explicitly described as being "used by a competent human observer to examine and count red blood cells and nucleated cells" and that "A competent human observer may change machine assignments, after which particle concentrations are recomputed and reported." Therefore, the reported performance is not a standalone (algorithm only) performance, but rather a system performance including the human-in-the-loop for review and potential correction.

7. The Type of Ground Truth Used

The ground truth used was expert manual chamber counting.

8. The Sample Size for the Training Set

The document does not provide information about a training set or its sample size. The focus is on the performance comparison of the device against the manual method.

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

Since no training set information is provided, there is no information on how its ground truth was established.

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The Sysmex pocH-100i Automated Hematology Analyzer is an automated cell counter intended for in vitro diagnostic use in a CLIA non-waived clinical laboratory (not for Point of Care Use in a CLIA waived laboratory). This instrument provides results for the following parameters: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, LYM%, MXD%, NEUT%, LYM#, MXD#, NEUT#, RDW-SD, RDW-CV, MPV.

The Sysmex pocH-100i is an automated hematology analyzer for use in CLIA non-waived clinical laboratories (not for Point of Care use in a CLIA waived laboratory).

The provided 510(k) summary for the Sysmex pocH-100i (K032677) does not contain explicit acceptance criteria tables or detailed study results demonstrating performance against specific thresholds. Instead, it focuses on demonstrating substantial equivalence to a predicate device through correlation studies.

Here's an breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The submission does not provide numerical values for accuracy, precision, or correlation coefficients that would typically be associated with acceptance criteria.

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

• Sample Size for Test Set: Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The document only states "Correlation studies were performed."

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

• Not applicable. The study performed was a correlation study comparing the new device against a predicate device, not against an expert-established ground truth. Therefore, no experts were used for this purpose in the context described.

4. Adjudication Method for the Test Set

• Not applicable, as the study was a correlation study against a predicate device, not an assessment requiring adjudication by multiple experts.

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

• No, a MRMC comparative effectiveness study was not done. This type of study is typically performed for imaging or interpretive devices where human readers are involved in diagnosis and interpretation. The Sysmex pocH-100i is an automated hematology analyzer, meaning it directly outputs numerical parameters and does not involve human interpretation in the same way.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Yes, implicitly. The comparison study between the pocH-100i and the predicate device (KX-21) demonstrates the standalone performance of the algorithm. Automated hematology analyzers operate as standalone systems, generating results without human intervention for each test. The correlation study evaluates the output of the pocH-100i itself against the output of the predicate device.

7. Type of Ground Truth Used

• Predicate device results. The "ground truth" in this context was established by the performance of the legally marketed predicate device, the Sysmex KX-21. The study aimed to show that the pocH-100i provided "equivalent performance" to the KX-21.

8. Sample Size for the Training Set

• Not applicable. As this is a 510(k) submission for a traditional automated medical device, not an AI/ML device, there is no mention of a "training set" in the context of machine learning model development. The device's operational parameters would have been established through engineering design and calibration, not through data-driven training of an algorithm in the modern sense.

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

• Not applicable, as there is no "training set" in the context of an AI/ML model for this device. The device's function is based on established physical and chemical detection methods (DC Detection, Non-Cyanide Hemoglobin Method).

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The ADVIA 120 cerebrospinal fluid (CSF) cell count is intended to provide an in vitro diagnostic, quantitative determination of blood cells in CSF specimens analyzed in the manual open tube mode. The ADVIA 120 provides leukocyte (WBC) and erythrocyte (RBC) counts along with both absolute and proportional counts for the WBC differential.

The revised ADVIA 120 CSF method consists of the following changes to the ADVIA 120 Hematology System.

1. A reformulated reagent that can be used to obtain CSF counts from a single optical channel of the ADVIA 120 system.
2. Revised software to calculate the cell counts.
3. A software key to selectively allow access to the CSF mode of the system software.
4. Control products to maintain quality control of the CSF method.

The following parameters are reported with the ADVIA 120 CSF method:
White Blood Cell Parameters
WBC - white blood cell count
Neut - neutrophil count (percentage and absolute counts)
Lymph - lymphocyte count (percentage and absolute counts)
Mono - monocyte count (percentage and absolute counts)
Eos - eosinophil count (percentage and absolute counts)
MN - mononuclear count (percentage and absolute counts)
PMN -- polymorphonuclear count (percentage and absolute counts)
Red Blood Cell Parameters
RBC - red blood cell count

• For Laboratory Use Only (not reportable)

Here's a breakdown of the acceptance criteria and study information for the revised ADVIA 120 CSF method, based on the provided text:

Acceptance Criteria and Device Performance

The submission states that the revised ADVIA 120 CSF method "meets the manufacturer's intended specifications." However, specific numerical acceptance criteria were not explicitly provided in the given text. The comparison focuses on the methods of operation between the predicate and revised device, rather than quantitative performance targets. Therefore, the table below will reflect the characteristics of the method comparison described.

Study Details

The provided text describes a submission for a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study report with all the elements typically found in such a report. Many of the requested details are therefore not explicitly stated in this summary.

Here's what can be inferred or explicitly stated:

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

   • Sample Size: Not specified in the provided text.
   • Data Provenance: Not specified. The abstract mentions "The test results included in this submission," implying internal testing by Bayer Corporation. There is no information about country of origin or whether the data was retrospective or prospective.

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

   • Not specified. Given that this is a hematology analyzer, the ground truth would typically be established by manual microscopy by trained laboratory professionals (e.g., medical technologists or hematologists), but this is not explicitly stated.

3. Adjudication method:

   • Not specified.

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 / Not done. This device is an automated hematology analyzer, not an AI diagnostic tool intended to assist human readers in image interpretation. The study evaluates the analyzer's performance directly, not human reader improvement.

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

   • Yes. This is an automated device designed to operate in "standalone" mode, performing the cell counts and differentiations without human interpretation of raw data in the loop during the analysis process. The "manual open tube mode" refers to how the sample is introduced to the system, not that human interpretation is integrated into the result generation.

6. The type of ground truth used:

   • Not explicitly stated in detail. For automated cell counters, the established ground truth is typically obtained through manual microscopy by skilled laboratory personnel using a hemocytometer for counts and stained slides for differentials. This is implied by the nature of the device but not directly stated.

7. The sample size for the training set:

   • Not applicable / Not specified. This device is an automated system based on light scatter and absorbance measurements, not a machine learning model that requires a distinct "training set" in the common sense of AI/ML. The development likely involved internal validation and calibration with various samples, but these are not referred to as a "training set."

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

   • Not applicable / Not specified. As noted above, there's no explicit mention of a "training set" in the context of an AI/ML model for which ground truth would be established for training purposes.

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The COULTER® Z2 instrument may be used for in vitro diagnostic use to determine the human erythrocyte concentration (Red Cell Count or RBC), leukocyte concentration (White Cell Count or WBC) and thrombocyte concentration (Platelet Count or Plt). In addition, the COULTER Z2 also provides the mean erythrocyte volume (Mean Cell Volume or MCV) and the mean thrombocyte volume (Mean Platelet Volume or MPV).

The COULTER Z2 is a general purpose dual threshold particle counter and sizer designed to count and size particles, suspended in an aqueous electrolyte solution, within the range of 1 to 120 um equivalent spherical diameter. The instrument is designed for both biological and industrial use. As with the predicate devices, the COULTER Z2 utilizes the Coulter principle for the enumeration and sizing of blood cells. The same reagent system, composed of an isotonic diluent, lytic reagent to lyse red blood cells for WBC measurement and instrument cleaner, is used on COULTER STKS, Z1, and Z2 instruments. The COULTER STKS, Z1, and Z2 instruments are capable of determining the human erythrocyte concentration (Red Cell Count or RBC), leukocyte concentration (White Cell Count or WBC) and thrombocyte concentration (Platelet Count or Plt). In addition, like the COULTER STKS, the COULTER Z2 also provides the mean erythrocyte volume (Mean Cell Volume or MCV) and the mean thrombocyte volume (Mean Platelet Volume or MPV). Both the COULTER Z1 and the Z2 instruments contain a hydraulic metering station built into the electronics main unit, measure a restricted range of particle sizes (within the range 1 to 120 µM) and utilize surface-mount technology. Operator-adjustable controls are accessible by means of a keyboard data terminal.

Here's a breakdown of the acceptance criteria and study information for the COULTER® Z2 Analyzer, based on the provided text:

Acceptance Criteria and Device Performance for COULTER® Z2 Analyzer

The provided document describes the COULTER® Z2 Analyzer and its substantial equivalence to predicate devices, focusing on the added parameters of Mean Cell Volume (MCV) and Mean Platelet Volume (MPV). The "acceptance criteria" are implicitly defined by the reported performance metrics (imprecision and accuracy) that demonstrate its equivalence to already commercially distributed hematology analyzers.

1. Table of Acceptance Criteria and Reported Device Performance

Since explicit "acceptance criteria" are not given in numerical ranges (e.g., "CV% must be

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The intended use of the Sysmex R-3500 is as a fully automated reticulocyte analyzer for in vitro diagnostic use in clinical laboratories.

The Sysmex™ R-3500 is an automated reticulocyte analyzer intended for in vitro use in clinical laboratories. The R-3500 provides accurate and precise test results for 8 analysis parameters in whole blood. These include RET%, RET#, RBC, IRF, LFR, MFR, HFR, and PLT. The R-3500 processes approximately 120 samples per hour and displays and prints the data for Reticulocyte number, Reticulocyte percent, Red blood cell count, Immature reticulocyte fraction, fluorescent ratios, and platelets along with representative scattergrams. Sample abnormalities are indicated by abnormal marks, flags, and error messages which appear on the DMS display screen and on the printout. This is an indication that the sample is not within the acceptable range and requires further review and investigation. The R-3500 uses the principle of flow cytometry for reticulocyte analysis. In the instrument, a whole blood sample is automatically aspirated, diluted and stained with a fluorescent dye (Auromine-O). The sample is hydrodynamically focused into a narrow path and passed through a flow cell, where it is illuminated by an Argon laser beam. The cells present in the sample will fluoresce and scatter light to varying degrees. It is the analysis of the intensity of emitted fluorescent light and intensity of scattered light which allows the R-3500 analyzer to detect and enumerate reticulocytes.

Here's a breakdown of the acceptance criteria and study details for the Sysmex™ Automated Reticulocyte Analyzer R-3500 based on the provided text:

1. Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined quantitative acceptance criteria (e.g., "RET% must have an r-value > 0.990"). Instead, it demonstrates the device's performance through correlation studies comparing it to a predicate device. The implicit acceptance criterion is "substantial equivalence" to the predicate device, which is supported by high correlation coefficients (r and r²) and regression equations.

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

• Sample Size: The sample size for the test set varied slightly by parameter:
  • RET# & RET%: 487 samples
  • RBC, IRF, LFR, MFR, HFR: 486 samples
  • Platelet: 482 samples
• Data Provenance:
  • Country of Origin: Not explicitly stated, but the "research center" where the studies were performed is mentioned. The manufacturer is TOA Medical Electronics Co. in Kobe, Japan, and the importer/distributor is Sysmex™ Corporation in Long Grove, IL, USA. Given the context of seeking FDA clearance, it's likely the studies were conducted to satisfy US regulatory requirements, but the specific geographic origin of the patient samples is not provided.
  • Retrospective or Prospective: The text states, "In these studies, the following comparative performance evaluations were conducted using the proposed device and the predicate device to evaluate specimens from apparently healthy individuals and from patients with different pathological conditions which are expected to affect the results for particular parameters." This suggests the samples were collected and then tested on both devices for comparison, which aligns with typical prospective or concurrent comparison study methodology. It doesn't indicate purely retrospective analysis of existing data.

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 a "ground truth" for the test set. The study compares the performance of the new device (R-3500) against an already cleared predicate device (RAM-1). The predicate device's measurements are effectively treated as the reference for comparison.

4. Adjudication Method for the Test Set

Not applicable. Since the comparison is primarily device-to-device measurements, there is no mention of human adjudication for the test set results. Each device generated its own results, which were then statistically compared.

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 is not an AI/algorithm-assisted human reading device. It's a fully automated analyzer. The study focuses on the comparison between two automated instruments.

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

Yes, the study described is a standalone performance evaluation. The Sysmex™ R-3500 is an automated reticulocyte analyzer. The performance data presented (correlation coefficients and regression equations) represent the device's measurements compared directly to those of a predicate automated device. There is no human intervention in the generation of the results being compared.

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

The "ground truth" in this context is established by the measurements from the predicate device, Sysmex™ SE/RAM-1. The study's objective is to demonstrate substantial equivalence, meaning the new device performs comparably to a legally marketed device.

8. The Sample Size for the Training Set

The document does not provide information about a "training set" or its sample size. This type of 510(k) submission for a diagnostic analyzer typically focuses on demonstrating the performance of the final, released device compared to a predicate, rather than detailing the development and training phases of an algorithm.

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

Not applicable, as no training set information is provided in the document.

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