(78 days)
The QBC® AUTOREAD™ System provides a diagnostic hematology profile on venous or capillary blood: hematocrit, hemoglobin, MCHC, platelet count, white blood cell count, granulocyte count (% and number), and lymphocyte/monocyte count (% and number).
The QBC® AUTOREAD™ System includes an analyzer, power pack, printer, centrifuge, and test accessories. The system uses specially designed tubes known as the QBC® AccuTube. AccuTubes are filled with blood and centrifuged. The spun tube is placed in the QBC® AUTOREAD™ analyzer which provides a report.
The provided text describes a 510(k) summary for the QBC® AUTOREAD™ System, focusing on its equivalency to a predicate device. Here's an analysis of the acceptance criteria and the supporting study, based on the information given:
Acceptance Criteria and Reported Device Performance
The core of the acceptance criteria for this 510(k) submission is demonstrating equivalency to the predicate device and established methods for hematology parameters. The "reported device performance" is essentially the statistical measures (correlation coefficient, slope, intercept) derived from the equivalency studies.
| Parameter | Acceptance Criteria (Implicit: Strong Correlation and Slope ~1, Intercept ~0 when compared to predicate/reference) | Reported Device Performance (Correlation Coefficient, Slope, Intercept) - Against Reference or Predicate |
|---|---|---|
| Hematocrit | Equivalent to spun microhematocrit method | Against Spun Microhematocrit: |
| Correlation Coefficient: 0.993 | ||
| Slope: 0.991 | ||
| Intercept: 0.270 | ||
| Equivalent to original QBC AccuTube/AUTOREAD System | Against Original QBC AccuTube/AUTOREAD: | |
| Correlation Coefficient: 0.999 | ||
| Slope: 0.975 | ||
| Intercept: 1.015 | ||
| Hemoglobin | Equivalent to impedance cell counter method | Against Impedance System: |
| Correlation Coefficient: 0.995 | ||
| Slope: 0.969 | ||
| Intercept: 0.410 | ||
| Equivalent to original QBC AccuTube/AUTOREAD System | Against Original QBC AccuTube/AUTOREAD: | |
| Correlation Coefficient: 0.999 | ||
| Slope: 0.981 | ||
| Intercept: 0.239 | ||
| Platelets | Equivalent to original QBC AccuTube/AUTOREAD System | Against Original QBC AccuTube/AUTOREAD: |
| Correlation Coefficient: 0.989 | ||
| Slope: 0.932 | ||
| Intercept: 11.633 | ||
| White Blood Cells | Equivalent to original QBC AccuTube/AUTOREAD System | Against Original QBC AccuTube/AUTOREAD: |
| Correlation Coefficient: 0.984 | ||
| Slope: 1.031 | ||
| Intercept: -0.116 | ||
| Granulocytes (#) | Equivalent to original QBC AccuTube/AUTOREAD System | Against Original QBC AccuTube/AUTOREAD: |
| Correlation Coefficient: 0.985 | ||
| Slope: 1.045 | ||
| Intercept: 0.002 | ||
| Lymphocytes/Monocytes (#) | Equivalent to original QBC AccuTube/AUTOREAD System | Against Original QBC AccuTube/AUTOREAD: |
| Correlation Coefficient: 0.967 | ||
| Slope: 0.921 | ||
| Intercept: 0.080 |
Study Details
Regarding the study that proves the device meets the acceptance criteria:
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Sample size used for the test set and the data provenance:
- Hematocrit and Hemoglobin equivalency study: 160 fresh EDTA whole blood samples.
- Data Provenance: The study was conducted at "two hospital sites". No specific country of origin is mentioned, but the company address is in Sparks, Maryland, USA, suggesting the data is likely from the United States. The samples were "fresh EDTA whole blood samples," indicating they were retrospectively collected from patients.
- Other Parameters (Platelets, WBC, Granulocytes, Lymphocytes/Monocytes): The sample size for these parameters is not explicitly stated, but it's implied to be the same set of samples or a comparable set used for the hematocrit and hemoglobin equivalency against the original QBC AccuTube.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This type of device (automated differential cell counter) does not typically rely on human expert consensus for "ground truth" in the same way as image-based diagnostics. The ground truth here is established by reference methods (e.g., spun microhematocrit method, impedance cell counter, or the established predicate device).
- Therefore, the concept of "number of experts" and "qualifications" doesn't directly apply here for establishing the ground truth, as it's a quantitative measurement device.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- No adjudication method is mentioned or relevant for this type of quantitative device study. Measurements are taken and compared directly to reference methods.
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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:
- No. This is not an MRMC comparative effectiveness study. It is a study to demonstrate the analytical equivalency of a diagnostic device to predicate devices and established reference methods. Human reader performance or AI assistance are not relevant to this type of submission.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, effectively. The "device" in question is an automated system (QBC® AUTOREAD™ System) which includes an analyzer and algorithms to generate results. The studies described evaluate the performance of this system (including its modified algorithm) in a standalone capacity against reference methods and the predicate device. There is no human interpretation component being evaluated in these specific studies; it's the machine's output.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Reference Methods:
- For Hematocrit: Spun microhematocrit method.
- For Hemoglobin: Impedance cell counter method.
- For all parameters (Hematocrit, Hemoglobin, Platelets, White Blood Cells, Granulocytes, Lymphocytes/Monocytes): The original QBC AccuTube read with the original QBC AUTOREAD algorithm (the predicate device).
- Reference Methods:
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The sample size for the training set:
- The document does not explicitly mention a separate "training set" or its size. Since this is a 510(k) summary for a device with modified components (AccuTube and algorithms), the modifications were likely developed and refined using internal data, but the submission focuses on the validation or test data to demonstrate equivalency. It is possible that the algorithm adjustments were "trained" on some data, but this information is not provided in the summary.
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How the ground truth for the training set was established:
- Given the lack of information on a "training set," there's no detail on how ground truth for such a set would have been established. However, for internal development, it would typically involve comparing preliminary device results against similar reference methods as used in the validation studies.
Conclusion: The studies described successfully demonstrate the equivalency of the modified QBC® AUTOREAD™ System to established reference methods and its predicate device for the measured hematology parameters, addressing the implicit acceptance criteria for this 510(k) submission.
§ 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.”