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The Sysmex® XS is an automated hematology analyzer for in vitro diagnostic use in clinical laboratories.

The XE-2000 and XT-Series are automated hematology analyzers previously cleared by the FDA. The XS performs hematology analyses using the following methods: Sheath Flow DC Detection Method, Flow Cytometry Methods using a Semiconductor Laser and SLS-hemoglobin method.

Here's an analysis of the provided information regarding the acceptance criteria and study proving the device meets them:

The document provided, a 510(k) summary for the Sysmex® XS, Automated Hematology Analyzer, primarily focuses on demonstrating substantial equivalence to predicate devices (Sysmex XE-2100 and Sysmex XT-Series). As such, the information regarding specific acceptance criteria and the detailed study proving the device meets them is limited and presented indirectly through the comparison to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state a table of acceptance criteria in numerical targets for metrics like accuracy, sensitivity, or specificity. Instead, the performance is demonstrated by showing "excellent correlation" to the predicate devices. The acceptance criterion is implicitly that the Sysmex XS performs comparably to the already cleared predicate devices.

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

• Sample Size: The document does not specify the exact sample size (number of patient samples) used for the comparison studies. It only states, "Studies were performed to evaluate the equivalency of XS to the predicate method."
• Data Provenance: The document does not specify the country of origin or whether the data was retrospective or prospective.

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

• The document does not explicitly mention the use of human experts to establish ground truth in the context of this 510(k) submission. For hematology analyzers, "ground truth" for parameters like cell counts and differentials is typically established by the predicate device's measurements, or by well-established reference methods and manual microscopy (which would require trained experts). Given the nature of a substantial equivalence claim for an automated analyzer, the primary comparison would be to the output of the predicate device.

4. Adjudication Method for the Test Set:

• The document does not mention any adjudication method as it relates to expert consensus or discrepancies. The comparison is between the new device's output and the predicate device's output.

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

• No, an MRMC comparative effectiveness study was not done. The Sysmex XS is an automated hematology analyzer, meaning it provides objective measurements without human interpretation in the primary analysis loop. Therefore, there is no "human reader" component to improve "with AI vs without AI assistance." The stated comparison is between the new automated device and existing automated predicate devices.

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

• Yes, implicitly, a standalone performance evaluation was done. As an automated analyzer, the Sysmex XS operates "algorithm only" without human intervention for its core measurement functions. The performance evaluation involved comparing its output directly to the output of other automated analyzers (the predicates).

7. The Type of Ground Truth Used:

• The primary "ground truth" for the comparison studies was implicitly the measurements and classifications provided by the legally marketed predicate devices (Sysmex XE-2100 and Sysmex XT-Series). The document states: "Comparison to the XE-2100 and XT-Series analysers demonstrated excellent correlation."

8. The Sample Size for the Training Set:

• The document does not specify a training set sample size. For an automated hematology analyzer, the "training" (calibration, algorithm development) would have occurred during the device's development phase, prior to this 510(k) submission seeking market clearance by demonstrating equivalence. The studies mentioned here are typically verification and validation studies on an already developed and potentially "trained" system.

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

• The document does not provide information on how the ground truth for any internal training data was established. This information would typically be part of the manufacturer's internal design control documentation and not usually detailed in a 510(k) summary, which focuses on demonstrating substantial equivalence for market clearance. It's likely that development would have involved reference methods, spiked samples, and potentially manual microscopy for initial calibration and algorithm refinement.

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