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510(k) Data Aggregation
(16 days)
The ABX PENTRA 60 and 60C+ Hematology Analyzer are fully automated (microprocessor controlled) hematology analyzer used for the in vitro diagnostic testing of whole blood specimens.
The ABX PENTRA 60 and 60C+ Hematology Analyzer are able to operate either in complete blood count (CBC) mode or in CBC + 5 differential leucocyte count (5DIFF) mode.
The ABX PENTRA 60 & PENTRA 60C+ are 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 PENTRA 60 is an standalone device using a keyboard and LCD screen integrated into the device. Whereas the PENTRA 60C+ is the PENTRA 60 connected to a dedicated workstation with user interfacing software.
The ABX PENTRA 60 and PENTRA 60C+ Hematology Analyzers underwent a study to demonstrate their performance against pre-defined acceptance criteria, primarily focusing on expanded linearity ranges and maintaining accuracy.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Precision | In accordance with EP5-A (NCCLS guidelines) | Good precision for all parameters, "entirely acceptable". |
| Linearity Range (WBC) | Not explicitly stated as a numerical range acceptance criterion, but the modification covers "extension of the linearity ranges for all parameters." | 0-120 x 10^3/μL |
| Linearity Range (RBC) | Not explicitly stated as a numerical range acceptance criterion, but the modification covers "extension of the linearity ranges for all parameters." | 0 - 8.0 x 10^5/μL |
| Linearity Range (HGB) | Not explicitly stated as a numerical range acceptance criterion, but the modification covers "extension of the linearity ranges for all parameters." | 0 - 24g/dl |
| Linearity Range (HCT) | Not explicitly stated as a numerical range acceptance criterion, but the modification covers "extension of the linearity ranges for all parameters." | 0 - 67% |
| Linearity Range (PLT with Hgb>2g/dl) | Not explicitly stated as a numerical range acceptance criterion, but the modification covers "extension of the linearity ranges for all parameters." | 0 - 1,900 x 10^3/μL |
| Linearity Range (PLT with Hgb<2g/dl) | Not explicitly stated as a numerical range acceptance criterion, but the modification covers "extension of the linearity ranges for all parameters." | 0 - 2800 x 10^1/μL |
| Accuracy (Inter-procedural Correlation for WBC & PLT) | Not explicitly stated as a numerical R^2 value acceptance criterion, but the aim was to show "no evidence of significant bias" against a predicate device. | R^2 > 0.95 |
| Accuracy (Inter-procedural Correlation for other parameters) | Not explicitly stated, but implies historical good correlation from previous submissions. | Good correlation demonstrated in previous submissions. |
| Carry-over | < 2.0% for WBC, RBC, HGB, PLT | < 2.0% for WBC, RBC, HGB, PLT |
| Electrical Safety | IEC 1010-1 standard | Complies with IEC 1010-1 standard. |
| Electromagnetic Compatibility (EMC) | EN 61326 standard | Complies with EN 61326 standard. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific number of samples or patients used for the linearity, precision, accuracy (inter-procedural correlation), or carry-over studies. It refers to "clinical data provided in this submission" and "clinical data of this study."
- Data Provenance: The company is ABX Diagnostics, located in Montpellier, France. The data is thus likely from France, or at least under the purview of ABX Diagnostics. The study appears to be retrospective in the sense that it evaluates the performance of the device and compares it to a predicate, not necessarily a prospective clinical trial with live patient enrollment. However, the term "clinical data" could imply prospective collection for validation purposes. The document doesn't provide enough detail to definitively classify it as solely retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not specify the number of experts or their qualifications used to establish ground truth. For hematology analyzers, ground truth often involves comparison to reference methods or manually performed differential counts by trained laboratory professionals (e.g., medical technologists or hematologists). The document only mentions comparison against the "Abbott CD 4000" as a predicate device for correlation.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method for the test set. Given that performance metrics like linearity, precision, and correlation against a predicate device are typically quantitative, a subjective adjudication process by experts is less commonly detailed for such studies compared to, for example, image interpretation tasks.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This section is not applicable. The device is an automated hematology analyzer, not an AI-assisted diagnostic tool that involves human "readers" or interpreters. The study focuses on the standalone performance of the instrument.
6. If a Standalone (Algorithm Only Without Human-in-the Loop Performance) Was Done
Yes, a standalone performance study was done. The entire premise of the submission is to demonstrate the performance of the ABX PENTRA 60 and PENTRA 60C+ Hematology Analyzers as fully automated devices, which analyze in-vitro samples without human intervention in the analysis process itself. The "Description" states they are "benchtop, clinical laboratory instrument which analyzes in-vitro samples of whole blood to provide complete blood count and leucocyte differential count."
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The primary "ground truth" or reference for the study was:
- Reference Methods/Standards: For precision, it was based on EP5-A (NCCLS guidelines), which provides methodologies for evaluating precision.
- Predicate Device Comparison: For accuracy (inter-procedural correlation), the ABBOTT CD 4000 (K961439) was used as a reference device. This implies that the measurements from the Abbott CD 4000, a legally marketed and presumably accurate device, served as the comparative ground truth.
8. The Sample Size for the Training Set
The document does not mention a training set or its sample size. This is because the device is a laboratory instrument based on established physical and chemical principles (cytochemistry, focused flow impedance, light transmission) rather than a machine learning or AI algorithm that requires a distinct training phase. The software modification mentioned covered linearity extension, which typically involves calibration and validation rather than a "training set" in the machine learning sense.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable as there is no mention of a training set for this type of device.
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