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The Sysmex™ XE-2100 is a multi-parameter hematology analyzer intended to classify the following formed elements in anti-coagulated blood: WBC, Neut%/#, Lymph%/#, Mono%/#, Eo%/#, Baso%/#, NRBC%/#, RBC, HGB, HCT, MCV, MCH, MCHC, RDW-CV, RDW-SD, RET%/#, IRF, HFR*, MFR*, LFR*, PLT, MPV, PDW*, P-LCR*, PCT* (*Not Reportable in USA).

The XE-2100 is an automated hematology analyzer which consists of four principal units: (1) Main Unit which aspirates, dilutes, mixes, and analyzes whole blood samples; (2) Sampler Unit which 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; (4) Pneumatic Unit which supplies pressure and vacuum from the Main Unit.

Here's an analysis of the acceptance criteria and study information for the Sysmex™ Automated Hematology Analyzer XE-2100, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state numerical acceptance criteria for the performance of the Sysmex™ XE-2100. Instead, it relies on demonstrating substantial equivalence to predicate devices (Sysmex SE/RAM-1 and SF-3000) and established methods (manual differential, flow cytometry).

The reported device performance is described as "performance to manufacturer specifications" for carryover, precision, linearity, and sample stability. For other parameters, performance is considered "similar to the predicate devices."

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

• Test Set Sample Size: The document does not explicitly state the specific number of samples used in the correlation studies. It mentions that "specimens were evaluated from apparently healthy individuals and from patients with different pathological conditions." This implies a varied and likely representative sample, but the exact count is not given.
• Data Provenance: The document does not state the country of origin of the data. The studies appear to be prospective as they were conducted to evaluate the performance of the XE-2100 against predicate devices and established methods.

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

• Number of Experts: The document does not specify the number of experts used.
• Qualifications of Experts: The document states that the WBC differential of the XE-2100 was correlated to results from "manual differentials performed according to NCCLS H20A." This implies that the manual differentials, which serve as a form of ground truth, were performed by trained laboratory professionals, adhereing to a recognized standard (NCCLS H20A). No specific experience level (e.g., radiologist with 10 years experience) is mentioned for these individuals.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (like 2+1 or 3+1) for establishing ground truth. The comparison for WBC differential was made against "manual differentials performed according to NCCLS H20A and to flow cytometry." This suggests a direct comparison to established methods rather than a consensus-based adjudication by multiple independent experts of the device's output.

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

No multi-reader multi-case (MRMC) comparative effectiveness study is mentioned in the provided text. The evaluation focuses on the device's performance against predicate devices and established laboratory methods, not on how the device assists human readers.

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

Yes, the study described is a standalone performance evaluation. The Sysmex XE-2100 is an "Automated Hematology Analyzer," and the studies (carryover, precision, linearity, sample stability, and correlation studies) evaluate the device's output directly against reference methods or predicate devices, without human-in-the-loop interaction as part of the primary performance assessment.

7. Type of Ground Truth Used

The ground truth used in the studies includes:

• Established Laboratory Methods:
  • Manual differentials performed according to NCCLS H20A for WBC differential.
  • Flow cytometry for WBC differential.
• Predicate Devices: The Sysmex SE/RAM-1 and SF-3000 served as a comparative reference for many parameters. While not strictly "ground truth," their established performance was used as a benchmark for substantial equivalence.

8. Sample Size for the Training Set

The document does not provide any information about a training set or its sample size. This is typical for devices of this era, especially those demonstrating equivalence to predicate devices, where extensive AI/machine learning training sets as understood today were not a primary requirement for 510(k) submission. The device's operation is based on established analytical principles (e.g., flow cytometry, DC detection).

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

As no training set is mentioned, there is no information on how its ground truth would have been established.

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