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The Sysmex XW-100™ is a quantitative automated hematology analyzer in vitro diagnostic point of care use to classify and enumerate the following parameters for venous whole blood anticoagulated with K2/K3 EDTA: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, LYM%, Other WBC%, NEUT%, LYM#, Other WBC#, NEUT#, RDW-SD. RDW-CV. and MPV. It is not for use in diagnosing or monitoring oncology patients, children under the age of 2, or for chronically or critically ill patients.

XW QC CHECK is a stabilized whole blood matrix designed for statistical process control of the Sysmex XW-100 automated hematology analyzer. It is not intended for calibration of the analyzer. Assayed parameters include WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, LYM%, Other WBC%, NEUT%, LYM#, Other WBC#, NEUT#, RDW-SD, RDW-CV, and MPV.

The XW-100 is an electrical resistance type blood cell counter. This technology may be variously referred to as direct current (DC) or impedance. The analyzer uses a human whole blood specimen and produces results for 17 hematology parameters, including the basic complete blood count (CBC), 3 part white blood cell (WBC) differential, and commonly used CBC indices. The analyzer uses DC with hydrodynamic focusing for all parameters except hemoglobin, which is measured photometrically. The patient sample is aspirated, measured, diluted with diluent (and Lyse for WBC measurement), then fed into a transducer chamber by means of a hydrodynamic focusing nozzle. The transducer chamber has a minute hole, or aperture. Electrodes are mounted on both sides of the aperture chamber, through which flows the DC. Blood cells suspended in the diluted sample are injected through the aperture by the hydrodynamic focusing nozzle. The hydrodynamic focusing nozzle is positioned in front of the aperture and in line with the aperture's center. This method improves cell counting accuracy because all blood cells are separated from each other and can only pass through the aperture in 1 direction, 1 at a time. When a cell passes through the aperture, it causes a change in the DC resistance that is directly proportional to its size. These resistance changes are captured as electric pulses. The various blood cell counts are calculated by counting the pulses that occur in each cell size category. The analyzer then determines blood cell volume and identifies rare and pathological cells by creating and analyzing histograms of the various cell populations using their respective pulse heights. Hemoglobin is measured photometrically using a noncyanide methodology, which reduces the presence of hazardous materials in the analyzer waste stream. The quality controls that are used with the XW-100 Automated Hematology Analyzer comprise XW QC CHECK, which contains stabilized red blood cell component(s), stabilized WBC component(s), and stabilized platelet component(s) in a preserving medium. XW QC CHECK components are packaged in glass vials with screw caps containing 2 mL. The vials are packaged in a welled vacuum-formed clamshell container. XW QC CHECK is stored at room temperature (15°C-25°C or 59°F-77°F).

Here's an analysis of the provided text regarding the acceptance criteria and study for the Sysmex XW-100™ and XW QC CHECK devices, based on the information available:

The document is a 510(k) premarket notification letter from the FDA, along with summaries for the Sysmex XW-100 Automated Hematology Analyzer and XW QC CHECK control material. The main purpose of these summaries is to demonstrate substantial equivalence to predicate devices, not typically to define explicit acceptance criteria in the same way a detailed validation study report would. Therefore, some requested information might not be explicitly stated.

Acceptance Criteria and Study for Sysmex XW-100™ and XW QC CHECK

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly list quantitative acceptance criteria in a structured table. Instead, it makes a general statement about the performance.

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

• Sysmex XW-100™ Analyzer: The document states that "Studies were performed to evaluate the equivalency of the Sysmex XW-100 in the point-of-care (POC) setting with the Sysmex pocH-100i automated hematology analyzer."
  • Sample Size: Not specified in the provided text.
  • Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).
• XW QC CHECK Control Material: The document states "Open-vial stability, closed-vial stability, and precision performance studies were conducted to establish performance of XW QC CHECK."
  • Sample Size: Not specified in the provided text.
  • Data Provenance: Not specified.

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

This information is not available in the provided text. For an automated hematology analyzer and control material, "ground truth" would typically be established by reference methods or predicate devices, rather than expert interpretation of raw data.

4. Adjudication Method for the Test Set

This information is not available in the provided text. Adjudication methods (like 2+1 or 3+1) are typically used for subjective assessments where multiple human readers are involved in creating a consensus ground truth. For an automated hematology analyzer, the "ground truth" would usually be established via a reference method or comparison to a predicate device, which wouldn't involve human adjudication in this manner.

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

This information is not available and is not applicable to this type of device. An MRMC study involves multiple human readers evaluating cases, often with and without AI assistance, to measure the improvement in human performance. The Sysmex XW-100™ is an automated analyzer, not an AI-assisted interpretation tool for human readers.

6. If Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

• Yes, implicitly. The Sysmex XW-100™ is an automated hematology analyzer. Its performance is its standalone performance without human input beyond sample loading and results interpretation. The studies described are inherently standalone evaluations of the device's ability to classify and enumerate blood parameters. The comparison is to a predicate device, not to human readers.

7. The Type of Ground Truth Used

• For the Sysmex XW-100™ Analyzer: The ground truth for evaluating its performance was established by comparison to the Sysmex pocH-100i™ Automated Hematology Analyzer (predicate device). The goal was to demonstrate "equivalent performance" to this existing device. This implies that the predicate device's results served as the reference or "ground truth" against which the new device's measurements were compared.
• For the XW QC CHECK Control Material: The ground truth for its performance (stability and precision) would be against defined acceptable ranges or established values, often determined by reference methods or internal validation standards for quality control materials for automated hematology analyzers. The document states it "met clinical performance acceptability criteria," implying established reference points.

8. The Sample Size for the Training Set

This information is not available in the provided text. Automated hematology analyzers like the Sysmex XW-100™ are typically based on well-established physical principles (e.g., electrical impedance, photometric measurement) rather than machine learning models that require explicit "training sets" in the contemporary sense of AI development. While there are internal calibrations and optimizations, they are not typically referred to as a "training set" in this context.

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

This information is not available and is not applicable in the AI/machine learning sense for this device. As noted above, the device operates on established physical principles. Any internal calibration or optimization would rely on reference measurements and established standards, rather than a "ground truth" for a training set as would be established for a machine learning algorithm.

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