(17 days)
XE Check is intended to be used as a control for evaluating complete blood cell count (CBC), white cell five-part differential, and reticulocyte percentage on Sysmex XE – 2100 series hematology instruments. The device will consist of three levels: Abnormal Low (characterized by low CBC, high reticulocyte %), Normal (normal CBC, normal reticulocyte %), and Abnormal High (high CBC, low reticulocyte %).
XE Check is a suspension of stabilized human red blood cells, human white cells, simulated human platelets, and simulated human reticulocytes packaged in glass vials containing 4.6 mL volumes. Closures are injection molded polypropylene screw-top caps. The vials are packaged in polystyrene jars.
The provided 510(k) summary for XE Check, an assayed hematology control, lacks detailed acceptance criteria and a fully described study proving device meets these criteria in the format requested. The document states that "Three studies of XE Check were conducted: l) Lot to Lot Reproducibility and Comparison to Whole Blood; II) Long Term Stability; and III) Open Vial Stability. Study results showed XE Check to be consistently reproducible, substantially equivalent to the predicate products, and stable for the entire product dating." However, it does not provide specific numerical acceptance criteria, reported performance values, or detailed study methodologies.
Therefore, many of the requested fields cannot be directly extracted from the provided text. Below is an attempt to answer the questions based on the available information, with clear indications where information is missing.
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document. The document generally states the device should be "consistently reproducible," "substantially equivalent to the predicate products," and "stable for the entire product dating" for controlling "CBC/Diff/Retic parameters on Sysmex XE - 2100 instruments." | "Study results showed XE Check to be consistently reproducible, substantially equivalent to the predicate products, and stable for the entire product dating." |
Detailed Study Information
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Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in the provided text.
- Data Provenance: Not specified in the provided text. It is implied to be prospective data generated during the product's development and testing by Streck Laboratories, Inc. in Omaha, Nebraska, USA.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable as this is a hematology control device, not an AI/diagnostic imaging device requiring expert ground truth for interpretation. The ground truth would be the expected values on the Sysmex XE-2100 instruments.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable for this type of device.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This is a quality control material for an automated hematology analyzer, not an AI-assisted diagnostic tool for human readers.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This device is a control material, not an algorithm. Its performance is evaluated in conjunction with the Sysmex XE-2100 instrument.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The document implies the "ground truth" for the performance evaluation would be the expected or reference values obtained from the predicate devices (SF Check, Retic Chex) or established by the Sysmex XE-2100 instrument for whole blood samples. For a control material, the ground truth is often defined by target values assigned during the manufacturing and characterization process, verified against reference methods or instruments. The study "Lot to Lot Reproducibility and Comparison to Whole Blood" suggests comparison to actual human whole blood as a reference.
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The sample size for the training set
- Not applicable. This is a physical control material, not a machine learning algorithm that requires a training set.
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How the ground truth for the training set was established
- Not applicable.
§ 864.8625 Hematology quality control mixture.
(a)
Identification. A hematology quality control mixture is a device used to ascertain the accuracy and precision of manual, semiautomated, and automated determinations of cell parameters such as white cell count (WBC), red cell count (RBC), platelet count (PLT), hemoglobin, hematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), and mean corpuscular hemoglobin concentration (MCHC).(b)
Classification. Class II (special controls). Except when intended for use in blood components, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.