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510(k) Data Aggregation
(36 days)
The ABX PENTRA DX 120 Hematology Analyzer is an automated hematology analyzer providing complete blood count (CBC), differential leucocyte count (DIFF) as well as reticulocyte count (RET), and nucleated red blood cell count (NRBC) for the in vitro diagnostic use in clinical laboratories.
The clinical use of the reticulocyte count, specifically the immature reticulocyte fraction (IRF), is to monitor erythropoietic activity in patients.
The option of the SPS Evolution (Slide Preparation System) smears and stains on a clean microscope slide.
The PENTRA DX 120 Automated Hematology Analyzer is a bench-top, clinical laboratory instrument which analyzes in-vitro samples of whole blood to provide complete blood count, leukocyte differential count, reticulocyte and NRBC count using principles of cytochemistry, focused flow impedance, light absorbance and fluorescence. The instrument is microprocessor driven.
Controlled by the PENTRA 120 the optional device SPS Evolution (Slide Preparation System) smears and stains the slides.
The provided text describes the ABX PENTRA DX 120 Hematology Analyzer and its associated SPS Evolution (Slide Preparation System). Here's a breakdown of the acceptance criteria and study information, based only on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance (NRBC Parameter)
The text focuses primarily on the Nucleated Red Blood Cell (NRBC) parameter as the new feature and provides limited, high-level performance statements rather than specific numerical acceptance criteria.
| Performance Metric | Acceptance Criteria (Implicit/General Statement) | Reported Device Performance |
|---|---|---|
| Precision (NRBC) | "good precision in accordance with EP5-A (NCCLS guidelines)" | "good precision ... and is entirely acceptable for the NRBC" |
| Linearity (NRBC/100 WBC Count) | "linearity limits claim... are entirely supported" | "entirely supported by the clinical data provided in this submission." |
| Accuracy (Inter-procedural Correlation - NRBC) | No specific numerical criteria stated, but implied to show no significant bias. | "showed no evidence of significant bias between the HoribaABX PENTRA DX 120 and the Abbott CD 4000, Sysmex XE-2100, and multiparameter flow cytometry with r^2 ranging between 0.96 - 0.98." |
| Differentiation (True/False Positives/Negatives - NRBC) | Implied to be comparable to predicate systems. | "provided good results on the differentiation between true & false positives and true & false negatives, comparable to other predicate systems." |
| Sample Stability (NRBC) | Implied to assure relative sample stability over 24 hours. | "assures a relative sample stability over a 24 hour period at both room temperature and 4°C." |
| Carry Over (NRBC) | Implied to be less than 1%. | "supporting a Carry Over claim of <1%" |
| Overall Clinical Testing | "met all acceptance criteria." | "Clinical testing met all acceptance criteria." |
Note: The text explicitly states that "Clinical testing met all acceptance criteria," but the specific numerical targets for these criteria are not detailed in the provided document.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The study is referred to as "clinical data" and "clinical studies."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not provided in the text. The ground truth for accuracy studies was established by comparison to predicate devices and multiparameter flow cytometry.
4. Adjudication Method for the Test Set
- This information is not provided in the text.
5. 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
- A MRMC comparative effectiveness study is not mentioned and is not applicable to an automated hematology analyzer, which performs calculations and classifications automatically without human intervention for the primary analysis.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Yes, the performance data described is for the standalone device (ABX PENTRA DX 120 Hematology Analyzer) without human intervention in the primary measurement and analysis of blood parameters. The device is an "Automated Hematology Analyzer."
7. The Type of Ground Truth Used
- For the NRBC parameter accuracy, the ground truth was established by comparison/correlation with predicate devices (ABBOTT CD 4000, SYSMEX XE-2100) and multiparameter flow cytometry.
8. The Sample Size for the Training Set
- This information is not provided in the text. Automated hematology analyzers typically don't have "training sets" in the same sense as machine learning or AI algorithms with distinct training phases documented in 510(k)s from this era, but rather are developed and validated against a range of clinical samples during their engineering and design process.
9. How the Ground Truth for the Training Set Was Established
- This information is not provided in the text. Given the nature of the device (automated hematology analyzer) and the era of the submission (2005), the concept of a separate "training set" with established ground truth as understood in modern AI/ML studies is less applicable or explicitly described in this document. Development would involve extensive testing against validated methods.
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