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The Diatron Abacus 5 System is a quantitative multi-parameter automated hematology analyzer designed for in-vitro-diagnostic use in clinical laboratories for enumeration of the following parameters in K3EDTA anti-coagulated venous whole blood samples: WBC, LYM%, LYM#, MON%, MON#, NEU%, NEU#, EOS%, EOS#, BAS%, BAS#, RBC, HGB, HCT, MCV, MCH, MCHC, RDWcv, RDWsd, PLT and MPV. The Diatron Abacus 5 is indicated for use to identify patients with hematologic parameters within and outside of established reference ranges.

The 'Abacus 5' is a fully automated high quality hematology analyzer for in vitro diagnostic use in clinical laboratories. It provides precise and accurate 5-part differential measurement using a laser based optical measurement technology. The 'Abacus 5' analyzer uses the impedance method for measurement of leukocytes (WBC), erythrocytes (RBC) and platelet (PLT) concentrations. Measurement of the hemoglobin (HGB) content of red blood cells is accomplished by photometric measurement technology. Five part leukocyte differential (LYM%, MON%, NEU%, EOS%, BAS%) is accomplished using optical laser-based flow cytometric technology. A vivid color touch screen display is featured with an intuitive, informative, and attractive user interface. A START button allows one-touch operation for ease of use. The 'Abacus 5' analyzer's unique software system supports the use of many commonly used external printers with its USB connections. The 'Abacus 5' internal database is capable of storing 100,000 patient, QC, and calibration result records including flags and graphical scatter diagrams and histograms. The system software is field-upgradeable to ensure up-to-date operation. An automatic optional Autosampler is available (sold separately) for automated processing of up to 100 sample tubes for increased laboratory efficiency. The 'Abacus 5' features advanced Ethernet LIS connectivity using the HL7 protocol in addition to standard serial interfaces, providing the clinical laboratory with flexible connectivity options.

Here's an analysis of the acceptance criteria and study information for the Diatron Abacus 5, Automated Hematology Analyzer, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state specific quantitative acceptance criteria or detailed reported device performance in a table format. Instead, it makes a general statement about meeting requirements and substantiating equivalence to the predicate device.

What is present:
The "Substantial Equivalence: Similarities" and "Substantial Equivalence: Differences" sections compare the Abacus 5 against the predicate device (Abbott CELL-DYN® 3700) across various technical and functional aspects. This comparison indirectly implies that the Abacus 5's performance across these characteristics is considered equivalent or acceptable relative to the predicate.

What is missing (typical for a detailed acceptance criteria table):

• Specific numerical ranges or thresholds for accuracy, precision, linearity, carryover, etc., for each of the measured parameters (WBC, LYM%, RBC, HGB, etc.).
• The actual measured values or statistical correlations observed in the study for these parameters.

Given the information, a table of acceptance criteria and reported performance cannot be fully constructed with quantitative values. The document states:

• Indication for Use
• Sampling Mechanisms
• Sample Processing
• Sample ID
• Methodology (e.g., Impedance for WBC, Photometric for HGB, Laser-based flow cytometry for 5-part diff)
• WBC Differential parameters
• Sample Type
• Main Parameters measured
• QC, Calibration, Flags/Alerts, Barcode Reader, External Printing, Data Input/Output, Microprocessors. Differences in methodology (RDWsd calculation vs. derivation), parameters (RDWcv measured, no RETC/IRF vs. vice versa), throughput, sample aspiration volume, reagents, calibrator/controls, data storage, LIS interface, keyboard, barcode reader, and peripheral ports were considered minor and did not raise new questions of safety or effectiveness. | The document asserts that "Diatron concludes...that the Diatron, Abacus 5 is substantially equivalent to the tested predicate device and has demonstrated to be a safe and effective product to be marketed in the United States." This implies that the device's performance across the listed criteria aligned sufficiently with that of the predicate device. Specific quantitative comparisons that would demonstrate substantial equivalence are stated to be in the Validation Report (A5-05-0020-02). |

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

The provided 510(k) summary does not specify the exact sample size used for the test set or provide details on data provenance (e.g., country of origin, retrospective/prospective). It generally refers to "performance and accuracy summary data" in an internal document, "Validation Report of Abacus 5 Hematology Instrument, Revision 2."

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

The 510(k) summary does not provide information on the number of experts used, their qualifications, or how ground truth was established for the "test set." For devices like automated hematology analyzers, ground truth often involves comparison to highly accurate reference methods or manual microscopy performed by skilled technicians or pathologists. This information is absent from the summary.

4. Adjudication Method for the Test Set

The document does not mention any adjudication method (e.g., 2+1, 3+1) for establishing ground truth for a test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study typically assesses how human readers' performance changes with and without AI assistance, which is not applicable to a standalone automated hematology analyzer like the Abacus 5. The device's purpose is to automate cell counting, not augment human interpretation in the same way an AI imaging tool might.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, a standalone performance study was implicitly done. The "Performance" section explicitly states: "All performance and accuracy summary data and conclusions can be referenced in document # A5-05-0020-02, Validation Report of Abacus 5 Hematology Instrument, Revision 2...All performance and accuracy data and data analysis in this submission support and substantiate equivalence to the selected predicate device."

This indicates that the device's performance, as an automated analyzer, was tested and evaluated on its own (i.e., "algorithm only") to demonstrate its accuracy against the predicate device. The device itself is designed for automated measurement without human intervention in the primary measurement process, although human interpretation of results and flags is part of its intended use.

7. Type of Ground Truth Used

The type of ground truth used is not explicitly stated in the summary. For hematology analyzers, ground truth often involves:

• Reference Method Comparison: Comparing results to accepted reference methods (e.g., manual differential counts by trained technologists/pathologists, or flow cytometry for certain cell populations).
• Predicate Device Comparison: Due to the nature of a 510(k) submission, a significant aspect of "truth" establishing is demonstrating equivalence to a legally marketed predicate device (Abbott CELL-DYN® 3700 in this case). This means the predicate device's performance serves as a de facto benchmark for acceptable "truth."

The summary refers to "performance and accuracy data" that "substantiate equivalence to the selected predicate device," strongly suggesting that comparison to the predicate device's results formed a key part of establishing the device's validated "truth."

8. Sample Size for the Training Set

The 510(k) summary does not provide information on the sample size for a training set. Hematology analyzers, especially those from 2012, might not rely on "training sets" in the same way as modern AI/machine learning algorithms. Their operation is based on fixed algorithms derived from biophysical principles (impedance, light scatter/absorption). If any parameter tuning or algorithm development involved data, it's not detailed here.

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

Since the mechanism of "training" (in the machine learning sense) is not described, the summary does not specify how ground truth for a training set was established. Modern AI/ML-driven medical devices would typically provide this detail. For this device, "ground truth" during development would likely have referred to standard clinical samples analyzed by established reference methods to refine the physics-based algorithms and ensure accurate mapping of electrical impedance and optical scatter data to cell parameters.

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