(249 days)
The DxH 300 COULTER Cellular Analysis System and the DxH 300C COULTER Cellular Analysis System are quantitative automated hematology analyzers for in vitro diagnostic use in clinical laboratories. The DxH 300 COULTER Cellular Analysis System and the DxH 300C COULTER Cellular Analysis System provide complete blood count, (WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, RDW-SD, PLT, MPV) and Leukocyte 3-Part Differential [LY (%/#), MO (%/#), GR (%/#)] for whole blood specimens, collected in a salt of EDTA [dipotassium (K2) or tripotassium (K3)] obtained by venipuncture, heel or fingerstick. The purpose of the DxH 300 and the DxH 300C is to identify normal human patients, with normal system-generated parameters, from patients whose results require additional studies.
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The provided text is a 510(k) submission for the DxH™ 300 and DxH™ 300C COULTER® Cellular Analysis Systems. It describes the device, its intended use, predicate devices, and summaries of performance studies.
Here's an analysis of the acceptance criteria and the studies that demonstrate the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly list quantitative "acceptance criteria" with specific thresholds for each performance metric. Instead, it states that the studies "demonstrated comparable results" or "acceptable results" or "met the internal validation acceptance criteria" when compared to predicate devices or established guidelines.
Here's a table summarizing the studies and their reported outcomes, as this is the closest we can get to the requested information from the provided text:
| Study | Acceptance Criteria (Inferred from study design and predicate comparison) | Reported Device Performance (DxH™ 300/300C) |
|---|---|---|
| Accuracy | Comparable results to the predicate device (COULTER® AcT Diff 2 ™) for all parameters (WBC, Lymph #, Mo #, Gran#, Lymph %, Mo%, Gran%, RBC, HGB, HCT%, MCV, MCH, MCHC, RDW, PLT, MPV) and COULTER® LH 780 for RDW-SD. | "The DxH 300 systems demonstrated comparable results to the predicate device with reagents stated above." |
| Precision | Acceptable precision performance as per CLSI EP5-A2. | "The DxH 300 systems demonstrated acceptable results with reagents stated above." |
| Linearity | Acceptable linearity results as per CLSI EP06-A. | "The DxH 300 systems demonstrated acceptable linearity results." |
| Carryover | Acceptable carryover results as per ICSH guidelines. | "The DxH 300 systems demonstrated acceptable carryover results." |
| Specimens (Stability) | Acceptable sample and prepared sample stability. | "Acceptable sample and prepared sample stability results achieved." |
| Reference Values | Reference intervals established as per CLSI C28-A3. | "Reference intervals established." |
| Performance (Normal & Clinical Samples) | Met internal validation acceptance criteria for analysis of normal and clinical samples as per CLSI H20-A2. | "The DxH 300 systems analysis of normal and clinical samples met the internal validation acceptance criteria" |
Note: The specific quantitative acceptance thresholds for "comparable" or "acceptable" are not detailed in this summary document. These would typically be found in the full study reports.
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify the sample size used for the test set in any of the studies (Accuracy, Precision, Linearity, Carryover, Specimen Stability, Reference Values, Performance).
The data provenance (e.g., country of origin, retrospective/prospective) is also not stated in this summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not mention the involvement of experts or how many were used to establish ground truth for any of the studies. These are automated hematology analyzers, and ground truth for many of these parameters is typically established through reference methods, calibrated standards, or comparative analysis with established predicate devices, rather than expert consensus on individual results. However, the accuracy study mentions CLSI H20-A2, which is for Reference Leukocyte (WBC) Differential Count (Proportional) and Evaluation of Instrumental Methods. This standard sometimes involves manual differential counts performed by trained laboratorians, but this document does not explicitly confirm this for the ground truth collection for this device.
4. Adjudication Method
The document does not describe any adjudication method like 2+1 or 3+1. Given the nature of an automated cellular analysis system, adjudication processes like these, which are common in image-based diagnostic AI, are typically not relevant. The studies focus on consistency, accuracy against reference methods, and comparison to predicate devices.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, the document does not indicate that a multi-reader multi-case (MRMC) comparative effectiveness study was done. The device is an automated hematology analyzer, meaning it performs the analysis without direct human interpretation of individual images/data points in the same way a radiologist interprets an X-ray. It's designed to provide quantitative results directly, with flags for abnormalities. Therefore, a study to measure human reader improvement with AI assistance would not be applicable in this context.
6. Standalone Performance Study
Yes, the studies described are standalone performance studies for the algorithm. The descriptions of "Accuracy," "Precision," "Linearity," "Carryover," "Specimens," "Reference Values," and general "Performance" all refer to the direct performance of the DxH 300/300C system itself, without human intervention in the primary measurement and calculation of the indicated parameters (WBC, RBC, HGB, etc.). The goal is to show the device performs acceptably on its own.
7. Type of Ground Truth Used
The type of ground truth used can be inferred from the reference standards cited:
- Accuracy: Ground truth was established by comparison to the predicate devices (COULTER® AcT Diff 2 ™ and COULTER® LH 780), which implies that the predicate devices served as a de facto "gold standard" or established reference method. The CLSI H20-A2 standard, referenced for WBC differential count, suggests that for differential parameters, ground truth might involve manual microscopy, although this isn't explicitly stated as the method within this document.
- Precision, Linearity, Carryover: Ground truth for these studies relies on statistically controlled experiments using characterized samples or materials, or comparison to established industrial standards (CLSI guidelines, ICSH document). For linearity, a range of samples with known values would be used.
- Reference Values: Established using healthy populations, based on CLSI C28-A3.
- Performance (Normal & Clinical Samples): Ground truth for evaluating normal and clinical samples would be based on clinical diagnoses and reference methods for the parameters being measured (likely including results from predicate devices or other established analyzers).
8. Sample Size for the Training Set
The document does not specify the sample size for the training set. As this device is a physical instrument rather than a machine learning algorithm in the modern sense (though it undoubtedly contains complex algorithms), the concept of a "training set" might not apply in the same way it does for a deep learning model. Device calibration and parameter optimization would have occurred during development, but specifics are not in this summary.
9. How the Ground Truth for the Training Set Was Established
Similarly, as a "training set" for a distinct AI algorithm is not explicitly mentioned, the document does not describe how ground truth for any training set was established. The development and calibration of such instruments typically involve extensive internal testing, using reference materials, characterized patient samples, and comparison to existing validated technologies. This process establishes the expected output and performance characteristics against which the device is optimized.
§ 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.”