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510(k) Data Aggregation
(30 days)
The ABX PENTRA 80 Hematology Analyzer is a fully automated (microprocessor controlled) hematology analyzer used for the in vitro diagnostic testing of whole blood specimens.
The ABX PENTRA 80 is able to operate either in complete blood count (CBC) mode or in CBC + 5 differential leucocyte count (5DIFF) mode.
The PENTRA 80 Hematology analyzer is a benchtop, clinical laboratory instrument which analyzes in-vitro samples of whole blood to provide complete blood count and leucocyte differential count using principles of cytochemistry, focused flow impedance and light transmission using a halogen light source. The instrument is microprocessor driven, with an internal PC that performs further data processing and hosts the user interface.
The provided text describes the ABX PENTRA 80 Hematology Analyzer and its performance in a 510(k) premarket notification. However, it does not contain a detailed table of acceptance criteria or performance metrics with specific numerical values for a direct comparison. The information is presented in a narrative format, highlighting that the device met certain standards and showed good correlation with a predicate device.
Here's an attempt to extract the requested information based on the available text:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Precision | Acceptable for all parameters (in accordance with EP5-A NCCLS guidelines) | "good precision... and is entirely acceptable for all available parameters." (No specific numerical values provided in the summary, only a general statement of compliance with guidelines.) |
| Linearity | Supported by clinical data | WBC (0-120 x 10^3/μL), RBC (0 - 8.0 x 10^6/uL), HGB (0 - 24g/dl), HCT (0 - 67%), PLT with Hgb>2g/1 (0 - 1,900 x 10^3/μL), and PLT with Hgb<2g/1 (0 - 2,800 x 10^3/uL) "are entirely supported by the clinical data provided." (No specific linearity coefficients or statistical measures provided in the summary.) |
| Accuracy (Inter-procedural Correlation) | Strong correlation (e.g., R^2 > 0.95 with predicate device) | "no evidence of significant bias between the PENTRA 80 and the Abbott CD 4000 provided good correlation of R^2>0.95 for WBC, PLT, RBC, HGB, HCT parameters." |
| Leukocyte Differentiation | Good results on differentiation between true & false positives and true & false negatives | "provided good results on the differentiation between true & false positives and true & false negatives." (No specific sensitivity, specificity, or accuracy metrics provided.) |
| Sample Stability | Relative sample stability over a 48-hour period at 4°C | "assures a relative sample stability over a 48 hour period at 4°C." |
| Carry Over | <2% for WBC, RBC, HGB, PLT | "Carry Over claim of <2% for WBC, RBC, HGB, PLT." |
| Safety and Effectiveness | Device safety and effectiveness not compromised, meet acceptance criteria, comply with standards | "safety and effectiveness of the device is not compromised. Clinical testing met all acceptance criteria... meets with the IEC 1010-1 standard... As well as the EN 61326 standard... All clinical and non clinical tests show appropriate levels of safety and effectiveness." |
2. Sample Size Used for the Test Set and Data Provenance
The document states that "The studies and data analysis were carried out in accordance with appropriate indications given by the FDA guidelines," and refers to "clinical data provided in this submission" and "clinical data of this study." However, no specific sample size for the test set is mentioned.
The data provenance is not explicitly stated in terms of country of origin. The study appears to be retrospective for comparison with a predicate device (Abbott CD 4000).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. The study primarily focuses on comparing the new device's performance against a predicate device and established guidelines (NCCLS, IEC) for various hematological parameters. There is no mention of human expert reading or consensus to establish ground truth for differential cell counts in the summary.
4. Adjudication Method for the Test Set
Since there is no mention of experts establishing a ground truth for a test set in the traditional sense of medical image analysis or complex diagnoses, there is no adjudication method described. The 'ground truth' appears to be derived from the performance of a predicate device (Abbott CD 4000) or established laboratory reference methods against which the ABX PENTRA 80 was tested.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No MRMC comparative effectiveness study was done as described for human readers. This device is an automated hematology analyzer, not an AI-assisted diagnostic tool designed to augment human interpretation in the way an MRMC study would typically evaluate.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the performance discussed in the document is for the standalone algorithm/device (ABX PENTRA 80 Hematology Analyzer) without human-in-the-loop performance being explicitly measured for its diagnostic output. The device is described as "fully automated (microprocessor controlled)."
7. The Type of Ground Truth Used
The ground truth appears to be established through:
- Comparison to a predicate device: Abbott CD 4000 (K961439) for accuracy and inter-procedural correlation.
- Compliance with established laboratory guidelines/standards: EP5-A (NCCLS guidelines) for precision, and implied standard methods for linearity and other parameters.
- Expected biological stability: For sample stability claims.
8. The Sample Size for the Training Set
The document does not mention a training set sample size. As a traditional automated laboratory instrument rather than a machine learning/AI diagnostic, the concept of a distinct 'training set' for the device's algorithms in the modern AI sense is not highlighted or described. The instrument's algorithms are likely based on established cytochemistry, impedance, and light transmission principles, calibrated and validated, rather than 'trained' on large datasets in the way current AI models are.
9. How the Ground Truth for the Training Set Was Established
Given the nature of the device as an automated analytical instrument and the lack of mention of a distinct training set in the AI sense, this information is not applicable or not provided in the summary. The "ground truth" for the device's operational principles would be rooted in fundamental scientific principles and established laboratory measurement techniques, rather than a dataset with annotated ground truth.
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