(271 days)
The ABX MICROS ES 60 (OT and CT models) is a quantitative multi-parameter, automated hematology analyzer for in vitro diagnostic use in clinical laboratories to identify and enumerate the following parameters: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, PLT, MPV, LYM%, LYM#, MON%, MON#, GRA%, GRA#, in K2EDTA and K3EDTA anticoagulated venous whole blood samples of adult patients and pediatric patients ≥ 1 month of age.
The ABX MICROS ES 60 is an automated hematology analyzer developed by HORIBA Medical and cleared under K141161. No modification (hardware or software) to the ABX MICROS ES 60 cleared device (K141161) was made to support the pediatric claim addition. Performance verification has been done to support the pediatric claim addition. The corresponding User Instructions for Use was updated to include this additional claim to the intended use.
The document describes the ABX MICROS ES 60, an automated hematology analyzer, and the studies conducted to support its expanded use for pediatric patients (≥ 1 month of age).
Here's the breakdown of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The document primarily focuses on comparability with a predicate device and reference interval validation for the pediatric claim. Specific quantitative acceptance criteria are indirectly implied by the "Bias was estimated at various data points, particularly around medical decision points, for each parameter. Bias was estimated for one replicate. Acceptance criteria were met for all measurands at all levels, except for RDW" statement. While the exact numerical acceptance limits for bias are not explicitly listed in a table, the document states they were met for all measured parameters except RDW.
For the Reference Interval, the acceptance criteria were that the results obtained from normal pediatric samples on the ABX MICROS ES 60 should fall within established pediatric reference ranges.
| Parameter | Acceptance Criteria (Implicit: Minimal Bias vs. Predicate) | Reported Device Performance |
|---|---|---|
| WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, PLT, MPV, LYM%, LYM#, MON%, MON#, GRA%, GRA# | Bias around medical decision points was within acceptable limits when compared to the predicate device. | Acceptance criteria were met for all measurands at all levels, except for RDW (due to different calculation methods). |
| Parameter (Reference Intervals for Pediatrics) | Acceptance Criteria (Results within Published Ranges) | Reported Device Performance (Table of Reference Ranges) |
|---|---|---|
| WBC, RBC, HGB, HCT, MCV, RDW, MCH, MCHC, PLT, MPV, LYM#, LYM%, MON#, MON%, GRA#, GRA% | Results from normal pediatric samples on ABX MICROS ES 60 fall within established pediatric reference ranges. | Combined Pediatric Reference Ranges (as given in the document) |
| Reference Range parameters | 1 m - 2 y | |
| WBC | (10³/mm³) | 5.0 - 20.0 |
| RBC | (10⁶/mm³) | 2.7 - 6.0 |
| HGB | g/dL | 8.9 - 18.0 |
| HCT | % | 28.0 - 55.0 |
| MCV | μm³ | 70 - 123 |
| RDW | % | 11.0 - 16.5 |
| MCH | pg | 22.7 - 36.0 |
| MCHC | % | 28 - 37 |
| PLT | (10³/mm³) | 140 - 562 |
| MPV | μm³ | 6.5 - 12.4 |
| LYM# | (10³/mm³) | 1.50 - 16.50 |
| LYM% | % | 26 - 86 |
| MON# | (10³/mm³) | 0.00 - 1.40 |
| MON% | % | 0 - 14 |
| GRA# | (10³/mm³) | 0.84 - 10.1 |
| GRA% | % | 10 - 80 |
2. Sample Size Used for the Test Set and Data Provenance
-
Comparability Study (Bias Estimation):
- Sample Size: 137 venous whole blood specimens.
- Age Range: Pediatric patients between 1 month and 21 years of age.
- Data Provenance: The study was conducted at two test sites in the US and one test site in France. This indicates a prospective study design, collecting samples specifically for the evaluation.
-
Reference Interval Study:
- Sample Size: 69 normal pediatric samples (37 female and 32 male).
- Age Range: Not explicitly stated for all, but categorized into 1m-2y, >2y-12y, and >12y-21y.
- Data Provenance: Performed at one test site in the US. This also suggests a prospective collection of samples from normal pediatric patients.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document does not mention the use of experts to establish ground truth for the test set.
- In the comparability study, the predicate device (Sysmex XN Series, XN-10) served as the reference standard for comparison. The performance of the predicate device is assumed to be the "ground truth" or accepted standard for those measurements.
- In the reference interval study, previously published pediatric reference ranges from several US hospitals were used as the "ground truth" for expected normal values.
Since this is an automated hematology analyzer measuring quantitative parameters, ground truth is typically established by comparison to other validated methods or established reference intervals, rather than by expert interpretation of images or data.
4. Adjudication Method for the Test Set
Not applicable, as expert adjudication (e.g., 2+1, 3+1) is specific to studies where human interpretation is involved in establishing ground truth, such as in image analysis or differential cell counts performed manually. For automated quantitative measurements, the comparison is typically against a reference method or validated ranges.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. These studies are typically performed to assess the impact of AI on human reader performance, usually in diagnostic imaging. This document describes the validation of an automated hematology analyzer, which does not involve human readers interpreting AI output.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the studies described are standalone performance evaluations. The ABX MICROS ES 60 is an automated hematology analyzer, meaning it operates without direct human intervention in the measurement and parameter calculation process. The studies assessed the device's performance directly against a predicate device and established reference ranges.
7. The Type of Ground Truth Used
- For the comparability study (bias estimation): The Sysmex XN Series, XN-10 (K112605) predicate device served as the reference for comparison. The measurements from this established device were considered the "ground truth" for assessing bias.
- For the reference interval study: Published pediatric reference ranges obtained from several US hospitals were used as the ground truth.
8. The Sample Size for the Training Set
The document does not describe a "training set" in the context of machine learning, as the ABX MICROS ES 60 is an automated analyzer based on physical principles (impedance, spectrophotometry) rather than a machine learning algorithm that is "trained" on data. The device was previously cleared under K141161, and this submission is for an additional pediatric claim without hardware or software modification to the cleared device. Therefore, no new training set or training process for the algorithm is described for this specific submission.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no mention of a "training set" for a machine learning algorithm in this 510(k) submission. The device operates based on established physical principles and its original validation (K141161) would have involved standard analytical validation studies.
§ 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.”