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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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