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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.

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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The ABX MICROS 60 Hematology Analyzer is a fully automated (microprocessor controlled) hematology analyzer used for the in vitro diagnostic testing of whole blood specimens or blood cell concentrates. It operates in complete blood count (CBC) mode.

The ABX MICROS 60 device is a benchtop, clinical laboratory instruments that analyze in-vitro samples of whole blood specimens. The device operates in a complete blood count (CBC) and 3 part DIFF (LMG). As either a closed tube / closed system (CT/CS) or open tube/open system (OT/OS). The ABX MICROS 60 can evaluate 5,8, 16 or 18 hematology parameters depending on its internal configuration.

Here's a summary of the acceptance criteria and study information for the ABX MICROS 60 Hematology Analyzer based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily discusses that the device met acceptance criteria, but specific quantitative criteria for each parameter are not explicitly detailed in a separate table. Instead, general statements about meeting guidelines and correlations are provided.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size for Test Set: Not explicitly stated. The document mentions "clinical data provided in this submission" and "clinical studies," but no specific sample size (number of patients or specimens) is given for the test set used to evaluate linearity and accuracy.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:

• Number and Qualifications of Experts: Not mentioned. For a hematology analyzer, ground truth typically refers to reference methods performed by trained laboratory personnel or comparison to a predicate device. The document states "Accuracy (Inter-procedural Correlation) demonstrated no evidence of significant bias between the MICROS 60 and the Abbott CD 4000," implying the Abbott CD 4000 served as the reference/ground truth for accuracy assessment.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable or not described. This type of adjudication is more common in studies involving subjective interpretation (e.g., medical imaging reads). For an automated hematology analyzer, performance is typically assessed by comparing its quantitative results against a reference method.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:

• MRMC Study: No, an MRMC study was not done. This type of study would involve human readers interpreting cases with and without AI assistance, which is not relevant for an automated hematology analyzer like the ABX MICROS 60. The device performs automated analysis without human interpretation in the loop.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Standalone Performance: Yes, the entire performance evaluation described is for the device in standalone mode. The ABX MICROS 60 is an "automated cell counter and automated differential cell counter" and a "fully automated (microprocessor controlled) multi-parameter hematology analyzer." The performance data presented (precision, linearity, accuracy) are for the device operating independently.

7. The Type of Ground Truth Used:

• Ground Truth Type:
  • For precision and linearity, the ground truth would typically be established by repeated measurements on stable samples and statistical analysis to ensure reproducibility and accurate measurement across concentration ranges.
  • For accuracy (inter-procedural correlation), the ground truth was established by comparison to a legally marketed predicate device, the ABBOTT CD 4000 (K961439).

8. The Sample Size for the Training Set:

• Training Set Sample Size: Not applicable or not stated. Hematology analyzers like the ABX MICROS 60 typically rely on established physical principles (e.g., impedance, optical scattering) and calibrated reagents rather than machine learning algorithms trained on a dataset. Therefore, the concept of a "training set" in the context of AI/ML is not directly relevant here. The device is "based on the same fundamental technology" as predicate devices.

9. How the Ground Truth for the Training Set Was Established:

• Training Set Ground Truth Establishment: Not applicable, as there isn't a "training set" in the AI/ML sense. The device's operation is based on established scientific principles rather than being trained on a dataset.

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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

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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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

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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