(69 days)
The Immature Granulocyte (IG) parameter on the Sysmex® XE-2100 is intended for in Vitro Diagnostic use to classify and count immature granulocyte cells in EDTA anti-coagulated blood.
The XE-2100 is an automated hematology analyzer previously cleared by the FDA. The Immature Granulocyte (IG) count is measured in the DIFF channel. The combination of side scatter, forward scatter, and fluorescent intensity of nucleated cells gives an image of each cell detected in the peripheral blood. Different leukocyte populations or clusters such as the immature granulocytes are counted by the XE-2100. (Note: XE-Pro and IG Master are required to obtain results described.)
The provided text describes the submission for a 510(k) premarket notification for the Immature Granulocyte (IG) parameter on the Sysmex® XE-2100™ Automated Hematology Analyzer. The submission states that studies were performed to evaluate the equivalency of the IG count to a predicate method, the manual microscopic differential cell count, and that these studies "indicated equivalent performance" and "demonstrated substantial equivalence." However, the document does not provide detailed acceptance criteria or the specific results of the study to prove that criteria were met. It only broadly states that the device showed good correlation and equivalent performance when compared to the manual count.
Therefore, the following information is extracted and inferred from the text:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Equivalence to the predicate method (manual microscopic differential cell count) | "Results indicated equivalent performance." |
| "Comparison to manual count showed good correlation." | |
| "The performance data demonstrated substantial equivalence." |
Study Details:
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Sample size used for the test set and data provenance:
- The document implies that the "manual differential cell counting" used as the predicate method typically counts "100 cells." It also mentions "The NCCLS H20-A method uses 400 cell differential performed by 2 techs each counting 200 cells." However, it does not explicitly state the sample size (number of patient specimens) used for the test set of the device evaluation studies.
- The data provenance (country of origin, retrospective/prospective) is not specified.
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Number of experts used to establish the ground truth for the test set and qualifications:
- The document states, for the manual method, "The NCCLS H20-A method uses 400 cell differential performed by 2 techs each counting 200 cells." This implies that at least two technicians were involved in establishing the ground truth for the manual method, which serves as the predicate. Their specific qualifications (e.g., years of experience) are not detailed beyond "techs."
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Adjudication method for the test set:
- The document states "2 techs each counting 200 cells" for the NCCLS H20-A method. This suggests a form of consensus or comparison between two readers, but the explicit adjudication method (e.g., 2+1, 3+1) is not specified.
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Multi-reader multi-case (MRMC) comparative effectiveness study:
- No MRMC comparative effectiveness study is explicitly mentioned. The evaluation is a comparison of the automated device's performance against a manual predicate method, not an assessment of how human readers improve with AI assistance.
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Standalone (algorithm only without human-in-the-loop performance) study:
- Yes, the description of the device's accuracy ("Automated counting of immature granulocytes on an automated hematology analyzer" and "Comparison to manual count showed good correlation") indicates a standalone study where the device's output is directly compared to the ground truth.
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Type of ground truth used:
- The ground truth used for comparison is the "Manual Microscopic Differential Cell Count," which involves human experts visually classifying and counting cells under a microscope. This can be considered expert consensus or expert visual assessment.
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Sample size for the training set:
- The document does not provide information on the sample size used for the training set. It focuses on the validation study against the predicate method.
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How the ground truth for the training set was established:
- The document does not provide information on how the ground truth was established for a training set.
§ 864.5220 Automated differential cell counter.
(a)
Identification. An automated differential cell counter is a device used to identify one or more of the formed elements of the blood. The device may also have the capability to flag, count, or classify immature or abnormal hematopoietic cells of the blood, bone marrow, or other body fluids. These devices may combine an electronic particle counting method, optical method, or a flow cytometric method utilizing monoclonal CD (cluster designation) markers. The device includes accessory CD markers.(b)
Classification. Class II (special controls). The special control for this device is the FDA document entitled “Class II Special Controls Guidance Document: Premarket Notifications for Automated Differential Cell Counters for Immature or Abnormal Blood Cells; Final Guidance for Industry and FDA.”