(24 days)
The ABX PENTRA 120 Hematology Analyzer is an automated hematology analyzer providing complete blood count (CBC) and differential leucocyte count (DIFF) for the in vitro diagnostic use in clinical laboratories.
The ABX PENTRA 120 RETIC Hematology Analyzer is an automated hematology analyzer providing complete blood count (CBC), differential leucocyte count (DIFF) as well as reticulocyte count (RET) for the in vitro diagnostic use in clinical laboratories. The clinical use in the ABX PENTRA 120 RETIC Hematology Analyzer of the reticulocyte count, specifically the immature reticulocyte fraction (IRF), is to monitor erythropoietic activity in patients.
The option of the SPS (Slide Preparation System) smears and stains on a clean microscope slide.
The PENTA 120 / P120 RETIC 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 and reticulocyte 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 (Slide Preparation System) smears and stains the slides.
Here's a breakdown of the acceptance criteria and study information for the ABX PENTRA 120/120 RETIC Hematology Analyzer and its SPS option, based on the provided text:
Acceptance Criteria and Reported Device Performance
The document describes improvements to the device, specifically the increase of linearity ranges for White Blood Cell (WBC) and Platelet (PLT) counts. For the SPS (Slide Preparation System), the focus was on the correlation of results between manual and automated methods.
Device Performance for ABX PENTRA 120/120 RETIC:
| Test / Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| WBC Linearity | (Not explicitly stated, but implies meeting previous standard and extending) | Linearity claim increase up to 150 x 10^3/uL |
| Platelet Linearity | (Not explicitly stated, but implies meeting previous standard and extending) | Linearity range up to 2000 x 10^3/uL |
| WBC Imprecision (Total CV%) | (Not explicitly stated, but typically below a certain threshold for diagnostic devices) | Ranged from 1.1% to 3.9% |
| Platelet Imprecision (Total CV%) | (Not explicitly stated, but typically below a certain threshold for diagnostic devices) | Ranged from 3.1% to 7.4% |
| WBC Accuracy / Bias (Correlation with predicate) | Good correlation expected (e.g., R^2 > 0.95 or 0.98) | R^2 = 0.995 (with Abbott CD 4000) |
| Platelet Accuracy / Bias (Correlation with predicate) | Good correlation expected (e.g., R^2 > 0.95 or 0.98) | R^2 = 0.99 (with Baker 9110 Plus) |
Device Performance for SPS (Slide Preparation System):
| Test / Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Correlation of results (Manual vs. SPS) | Excellent correlation expected | Excellent correlation demonstrated |
| Identification of pathologies | Correct identification of all pathologies | All pathologies were correctly identified |
General Acceptance:
- Clinical testing met all acceptance criteria.
- The device meets the IEC 1010-1 standard for electrical equipment for measurement, control, and laboratory use.
- All clinical and non-clinical tests show appropriate levels of safety and effectiveness.
Study Details
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Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated for specific tests (e.g., how many samples were used for linearity assessment, imprecision, or accuracy). The document mentions "all WBC results compared" and "all platelet results compared," suggesting a comprehensive comparison across the tested range.
- Data Provenance: Not specified (e.g., country of origin, specific hospitals). The studies are described as "clinical testing." "Retrospective or prospective" is not mentioned.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not mentioned. For automated hematology analyzers, ground truth often comes from established predicate devices and internal validation standards (e.g., reference methods, manual microscopy by trained professionals). For the SPS, the "manual method" served as the comparison, implying human expert evaluation.
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Adjudication method for the test set:
- Not mentioned.
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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, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or described. This type of study is more common for diagnostic imaging AI systems where human interpretation is a primary output. The ABX PENTRA is an automated analyzer, and the SPS automates slide preparation, not interpretation.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, the performance data presented (linearity, imprecision, accuracy) for the ABX PENTRA 120/120 RETIC represents the standalone performance of the algorithm/instrument. For the SPS, its function is automated slide preparation, which is inherently a "standalone" or automated process that is then evaluated against a manual process.
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The type of ground truth used:
- For the ABX PENTRA 120/120 RETIC (WBC and PLT counts): The ground truth was established by comparison to predicate devices (ABBOTT CD 4000 for leukocytes and BAKER 9110 Plus for platelets), which are considered established and accurate methods. Linearity data was "generated according to FDA guidelines," implying recognized reference standards.
- For the SPS: The ground truth was the "manual method" of smearing and staining slides, which would involve human expertise in microscopy for evaluation.
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The sample size for the training set:
- Not mentioned. As this is an automated analyzer dealing with fundamental blood cell counts and not a machine learning model in the contemporary sense, the concept of a distinct "training set" for algorithm development as seen in AI is not directly applicable in the same way. The device is likely calibrated and validated through engineering and typical quality control samples.
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How the ground truth for the training set was established:
- Not applicable in the context of "training set" for an AI model. For general instrument calibration and validation, ground truth would be established using reference materials, assayed controls, and comparisons to established, highly accurate (often manual or predicate) methods.
§ 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.”