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The PointCare NOW System is an automated hematology system intended for in vitro diagnostic use in performing the direct enumeration of major white blood cell populations, certain T-lymphocyte subsets, and hemoglobin concentration from human whole blood.

Whole blood samples can be analyzed with the PointCare NOW System for the following parameters:

• White Blood Cell Count
• Lymphocyte Count
• Lymphocyte Percentage (of White Blood Cells)
• CD4 T-Lymphocyte Count
• CD4 Percentage (of total Lymphocytes)
• Monocyte Count
• Monocyte Percentage (of White Blood Cells)
• Neutrophil Count
• Neutrophil Percentage (of White Blood Cells)
• Eosinophil Count
• Eosinophil Percentage (of White Blood Cells)
• Hemoglobin Concentration

The PointCare NOW System and its methods for immune hematology analysis are intended for in vitro diagnostic use in clinical laboratory settings.

The PointCare NOW System is a compact bench top immune hematology system that from analysis of a whole blood sample reports the hematology parameters identified within the Intended Use section below. The PointCare NOW System consists of an analysis instrument with an integrated touch screen interface and a commercially available tape roll printer.

The CD4NOW Gold Pack is used within the PointCare NOW System and all assay steps are performed on whole blood with capped bar-coded reagents designed for use on the PointCare NOW System. All assay aspiration, dispensing and mixing steps are automated. The PointCare NOW System reports parameter results on the basis of software analysis of light scatter measurements with the use of non-fluorescent reagents. Automated cell population cluster analysis is performed by the software and results provided with no operator interpretation.

The PointCare NOW System is an automated immune hematology system designed for in vitro diagnostic use, performing direct enumeration of major white blood cell populations, certain T-lymphocyte subsets, and hemoglobin concentration from human whole blood.

Here's an analysis of its acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state specific, quantifiable acceptance criteria for each parameter (e.g., specific ranges for precision, linearity, or acceptable bias compared to reference methods). Instead, it describes general positive outcomes of the testing.

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

• Sample Size: "A multi-site prospective study was conducted at four investigational sites to evaluate the performance of the PointCare NOW System with other commercially available methods. A total of evaluable samples were analyzed across all participating sites." The specific numerical total of evaluable samples is not provided in the summary.
• Data Provenance: The study was a "multi-site prospective study," indicating the data was collected specifically for this evaluation. The country of origin is not explicitly stated, but the sponsor is a US company (Marlborough, MA), and the FDA 510(k) process is for devices marketed in the United States, suggesting the study likely took place in the US or in a region using similar clinical standards.

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

This information is not provided in the summary. The clinical testing describes a comparison to "other commercially available methods" (reference methods), but it does not specify direct expert interpretation or a panel of experts to establish a "ground truth" that would be distinct from the output of the reference methods themselves.

4. Adjudication Method for the Test Set

This information is not provided in the summary. Since the comparison is against "commercially available methods" (likely established laboratory analyzers), it's improbable that a separate adjudication process involving human experts to resolve discrepancies was conducted in the typical sense for image interpretation or diagnosis. Instead, the reference methods are likely considered the "ground truth" or standard for comparison.

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, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or described for this device. The PointCare NOW System is an automated analyzer, meaning it generates results without direct human interpretation in the workflow. The summary explicitly states: "Automated cell population cluster analysis is performed by the software and results provided with no operator interpretation." Therefore, the concept of "human readers improving with AI assistance" does not apply to this device's intended use according to the provided information.

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

Yes, a standalone performance evaluation was done. The entire premise of the PointCare NOW System, as described, is its automated nature. The summary states: "Automated cell population cluster analysis is performed by the software and results provided with no operator interpretation." The clinical testing directly evaluates the performance of the PointCare NOW System (the algorithm/device as a whole) against reference methods.

7. The Type of Ground Truth Used

The ground truth for the clinical study was established by "other commercially available methods" which served as "reference methods." These would typically be established, FDA-cleared or CE-marked hematology analyzers or flow cytometers that are widely accepted in clinical laboratory settings. This implicitly means the ground truth is derived from established laboratory analysis/measurement, not pathology review, expert consensus on images, or long-term outcomes data.

8. The Sample Size for the Training Set

This information is not provided in the summary. The document describes performance testing for regulatory submission but does not delve into the development or training of the internal software/algorithms.

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

This information is not provided in the summary. As the document focuses on regulatory performance testing, details about the internal development and training of the device's algorithms or the ground truth used during that stage are not included.

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Sysmex® XE-5000 is an automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The XE-5000 classifies and enumerates the same parameters as the XE-2100 using whole blood as described below, cord blood for HPC and has a body fluid mode for body fluids. The Body Fluid mode analyzes WBC-BF, RBC-BF, MN%#, PMN%# and TC-BF in body fluids (cerebrospinal fluids (CSF), serous fluids, and synovial fluids with EDTA, as needed).

The Sysmex® XE-5000 is part of the XE-Series instrument line. It is a multi-parameter hematology analyzer intended to perform tests in anti-coagulated blood and body fluids. The instrument consists of three principal units: (1) Main Unit which aspirates, dilutes, mixes and analyzes blood and body fluid samples; (2) Auto Sampler Unit supplies samples to the Main Unit automatically; (3) IPU (Information Processing Unit) which processes data from the Main Unit and provides the operator interface with the system. The XE-5000 is equipped with a Sampler that provides continuous automated sampling for up to 100 tubes. The XE-5000 performs analyses using the following methods: RF/DC Detection Method, Sheath Flow DC Detection Method, and Flow Cytometry Methods using a Semiconductor Laser. Particle characterization and identification is based on detection of forward scatter, fluorescence and adaptive cluster analysis. Using the same reagents as the XE-2100, the XE-5000 automatically classifies cells from blood and body fluids and carries out all processes automatically from aspiration of the sample to outputting the results. The body fluid analysis mode of the XE-5000 uses the 4DIFF scattergram & the RBC distribution obtained from a specialized analysis sequence to calculate & display the WBC (WBC-BF) counts, mononuclear cell (MN) / polymorphonuclear cell (PMN) counts & percentages, TC-BF (Total Count) & RBC (RBC-BF) counts found in the body fluid. Analysis results and graphics are displayed on the IPU screen. They can be printed on any of the available printers or transmitted to a Host computer.

Here's a breakdown of the acceptance criteria and study information for the Sysmex XE-5000, based on the provided text:

Acceptance Criteria and Device Performance

The document states that the performance of the XE-5000 whole blood mode is the same as the XE-2100 with additional masters. For the Body Fluid mode, which has additional parameters (WBC-BF, RBC-BF, MN%/#, PMN%/#, TC-BF#), the claim is "excellent correlation" to the XE-2100 Body Fluid. The acceptance criteria themselves are not explicitly listed as specific numerical thresholds, but rather implied by "manufacturer's specification" and "excellent correlation".

Note: The document only mentions "manufacturer's specification" without providing the specific numerical values for these specifications (e.g., specific accuracy percentages, CVs for reproducibility, etc.). It claims "excellent correlation" to the predicate device, the Sysmex XE-2100.

Study Information

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

   • Sample Size: Not explicitly stated as a number of samples. The document mentions "Data consisting of carryover, linearity, accuracy and reproducibility was collected to show performance to the manufacturer's specification for the Body Fluid mode."
   • Data Provenance: Not explicitly stated (e.g., country of origin, specific institutions). The text also doesn't specify if the study 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 applicable/Not mentioned. The study involves comparing the new device against a predicate device (Sysmex XE-2100) and against manufacturer's specifications, rather than using expert-established ground truth for each case. The ground truth for the predicate device would have been established previously.

3. Adjudication method for the test set:

   • Not applicable/Not mentioned. The study appears to be a direct comparison of instrument measurements rather than an assessment requiring multiple human readers and adjudication.

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:

   • No. This is an automated hematology analyzer, not an AI-assisted diagnostic tool for human readers in the traditional sense of an MRMC study.

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

   • Yes, the performance data presented is for the standalone device, the Sysmex XE-5000, in comparison to another standalone device (Sysmex XE-2100). The device is an "automated hematology analyzer," implying standalone operation.

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

   • For the body fluid mode, the ground truth for comparison appears to be the performance of the Sysmex XE-2100 Body Fluid (the predicate device), as well as the manufacturer's internal specifications for parameters like accuracy, linearity, and reproducibility.

7. The sample size for the training set:

   • Not applicable/Not mentioned. The document describes a new iteration of an existing automated analyzer, not a machine learning model that requires a distinct training set. The "training" in this context would likely refer to the internal validation and development data used during the instrument's design process, which is not detailed here.

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

   • Not applicable/Not mentioned, as there is no specific "training set" described for a machine learning algorithm. If considered from an instrument development perspective, the ground truth for optimizing the instrument's performance would rely on established laboratory methods and reference ranges.

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The ABX PENTRA DX 120 Hematology Analyzer is an automated hematology analyzer providing complete blood count (CBC), differential leucocyte count (DIFF) as well as reticulocyte count (RET), and nucleated red blood cell count (NRBC) for the in vitro diagnostic use in clinical laboratories.

The clinical use of the reticulocyte count, specifically the immature reticulocyte fraction (IRF), is to monitor erythropoietic activity in patients.

The option of the SPS Evolution (Slide Preparation System) smears and stains on a clean microscope slide.

The PENTRA DX 120 Automated Hematology Analyzer is a bench-top, clinical laboratory instrument which analyzes in-vitro samples of whole blood to provide complete blood count, leukocyte differential count, reticulocyte and NRBC count using principles of cytochemistry, focused flow impedance, light absorbance and fluorescence. The instrument is microprocessor driven.

Controlled by the PENTRA 120 the optional device SPS Evolution (Slide Preparation System) smears and stains the slides.

The provided text describes the ABX PENTRA DX 120 Hematology Analyzer and its associated SPS Evolution (Slide Preparation System). Here's a breakdown of the acceptance criteria and study information, based only on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance (NRBC Parameter)

The text focuses primarily on the Nucleated Red Blood Cell (NRBC) parameter as the new feature and provides limited, high-level performance statements rather than specific numerical acceptance criteria.

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