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The A . T 10 Series is also a leukocyte differential counter. Both instruments are For In Vitro Diagnostic Use in clinical laboratories.

The COULTER® A. T Series Analyzers have the same intended use as the predicate device.

The product is a hematology Automated Cell Counter and Automated Differential Cell Counter which like the predicate device, COULTER® COUNTER® S-PLUS IV and LYSE S PLUS D, uses the Coulter method of impedance measurement for particle counting and sizing. Blood cells passing through a small opening simultaneously with an electric current cause an impedance change in the orifice. This electrical pulse can be sized and counted. While the number of pulses indicates the particle count, the size of the electrical pulse is proportional to cell volume.

Under the controlled condition of lysis, a chemical reaction demonstrates one distinct population of leukocytes: lymphocytes. Mature normal lymphocytes and variant atypical lymphocytes are the WBC cells, and tend to occupy the size range from 35 to 90 fL.

The COULTER® ACT Series Analyzers are quantitative, automated hematology analyzers.

Here's an analysis of the provided 510(k) summary regarding the COULTER® AC-T Series Analyzer, framed around your requested points:

COULTER® AC-T Series Analyzer Study Analysis

Based on the provided 510(k) summary, the following information can be extracted regarding acceptance criteria and the study conducted:

1. Acceptance Criteria and Reported Device Performance

The summary states that "Testing met all acceptance criteria" for precision, accuracy, and carryover. However, specific numerical acceptance criteria or detailed performance results (e.g., specific coefficients of variation for precision, correlation coefficients for accuracy limits for carryover) are not provided in this summary. To fully address this point, one would need to consult the full 510(k) submission document.

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

The provided summary does not specify the sample size used for the test set. It also does not specify the data provenance (e.g., country of origin, retrospective or prospective). This information would typically be detailed in the full study report.

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

The summary does not provide information on the number of experts used to establish ground truth, nor their qualifications. Given the device is an automated cell counter, the "ground truth" for parameters like WBC, RBC, Hgb, etc., would typically be established by reference methods or predicate devices, not visual expert review. For the differential counts (LY # and LY %), a manual differential performed by a qualified medical technologist or pathologist would serve as the ground truth.

4. Adjudication Method for the Test Set

The summary does not specify any adjudication method. For automated cell counters, adjudication in the sense of reconciling differing expert opinions is generally not applicable for basic CBC parameters. For differential counts, if multiple manual differentials were performed for ground truth, an adjudication method might be used, but this is not mentioned.

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

There is no indication of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study being conducted. This type of study is more common for imaging devices where human interpretation is a primary component. The COULTER® AC-T Series Analyzer is an automated instrument, and while its results would be compared to a reference method, it's not a human-in-the-loop diagnostic aid in the way an MRMC study evaluates.

6. Standalone Performance Study

Yes, a standalone performance study was clearly done. The entire submission focuses on the performance of the COULTER® AC-T Series Analyzer itself in determining parameters like WBC, RBC, Hgb, Hct, MCH, MCH, Plt, LY #, and LY %. The testing for precision, accuracy, and carryover directly assesses the algorithm's (and instrument's) performance without human intervention in the result generation.

7. Type of Ground Truth Used

Based on the nature of the device (automated hematology analyzer) and the parameters measured, the ground truth would most likely be established using:

• Reference Methods: For parameters like hemoglobin, established spectrophotometric methods would be used.
• Predicate Device Comparison: The summary explicitly states substantial equivalence to the COULTER® COUNTER® S-PLUS IV and LYSE S PLUS D (K823355), implying that results from the predicate device (or a similar reference analyzer) would be used as a gold standard for accuracy testing.
• Manual Differentials: For the leukocyte differential counts (LY # and LY %), the ground truth would be established by expert microscopic review of blood smears by qualified medical technologists or pathologists.

The summary does not explicitly state the type of ground truth, but these are the standard practices for this type of device.

8. Sample Size for the Training Set

The summary does not provide information on the sample size for the training set. Automated hematology analyzers typically do not undergo "training" in the machine learning sense that current AI algorithms do. Instead, their internal algorithms are developed and refined through extensive R&D and calibration procedures, often using a large, diverse set of samples. If this device utilized classical parameter-based algorithms, there wouldn't be a distinct "training set" in the modern AI context.

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

As mentioned above, the concept of a "training set" and "ground truth for a training set" as typically understood in recent AI/ML contexts does not directly apply to this 1996 device in the same way. The internal algorithms for counting and sizing are based on the established Coulter principle and refined through engineering and calibration rather than iterative machine learning. If any "calibration" or developmental samples were used, their "ground truth" would have been established through highly controlled reference methods or predicate device comparisons.

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The Cell-Dyn 3500 is a multi-parameter, hematology analyzer designed for In-Vitro diagnostic use in clinical laboratories.

The Cell-Dyn 3500 is a table-top analyzer consisting of the main analyzer, data station, and printer. An optional Sample Loader can be attached to the analyzer to transport samples in racks for automated processing.

The instrument has two sampling modes: Open Sample Aspiration Mode and Closed Sample Aspiration Mode. The instrument has the capability of diluting a sample for a CBC including a 5-part WBC differential for a total of 20 parameters. The 20 reportable parameters are as follows:

White blood cells (WBC), red blood cells (RBC), platelets (PLT), percent of neutrophils (%N), number of neutrophils (NEU), percent of lymphocytes (%L), number of lymphocytes (LYM), percent of monocytes (%M), number of monocytes (MONO), percent of eosinophils (%E), number of eosinophils( EOS), percent of basophils (%B), number of basophils(BASO), hemoglobin (HGB), hematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), red cell distribution width (RDW) and mean platelet volume (MPV).

The provided text describes the Cell-Dyn® 3500 System, a multi-parameter automated hematology analyzer, and presents data supporting its substantial equivalence to previously marketed devices. However, it does not contain detailed acceptance criteria or a study proving that the device meets those criteria in the format requested. The document focuses on demonstrating substantial equivalence rather than explicit performance acceptance criteria with detailed study results against them.

Therefore, many of the requested fields cannot be directly extracted from the provided text. I will fill in what information is available and note when information is missing.

Here's a breakdown of the available information:

1. A table of acceptance criteria and the reported device performance:

The document states: "The accuracy, precision and linearity data shows performance to manufacturer's specifications. The data supports our claim that the Cell-Dyn 3500 is substantially equivalent to the Coulter S+IV." However, the manufacturer's specifications (i.e., the acceptance criteria) and the specific reported device performance data for these parameters are not provided in the text.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Sample size for test set: Not specified. The document mentions "The data compiled to support the claim...".
• Data provenance: Not specified. (e.g., country of origin, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• For the WBC differential accuracy, it states: "The Cell-Dyn 3500 WBC differential has been compared to the NCCLS reference microscopic manual differential method for accuracy." This implies that trained personnel performed the manual differential counts for comparison, which would serve as a form of ground truth.
• Number of experts: Not specified.
• Qualifications of experts: Not specified. (However, performing NCCLS reference microscopic manual differential implies trained laboratory technicians or pathologists).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not specified.

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:

• No, this is not an MRMC study related to AI assistance. The device is an automated hematology analyzer, not an AI-assisted diagnostic tool as typically understood in the context of MRMC studies for image analysis etc. The comparison is between the automated analyzer's results and established manual/other automated methods.

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

• Yes, this is effectively a standalone performance study. The document describes the "Cell-Dyn 3500" analyzer's performance (accuracy, precision, linearity, carryover) and its comparison to other instruments and a manual method. This assesses the device's inherent performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• For WBC differential accuracy: The "NCCLS reference microscopic manual differential method" was used as a ground truth comparison.
• For other parameters (accuracy, precision, linearity, carryover): The implied ground truth would be accepted laboratory reference methods or established standards against which the device's measurements are validated.

8. The sample size for the training set:

• Not applicable / not specified. This device is from 1996 and uses electrical impedance and laser optical methods, not machine learning or AI models in the modern sense that require a "training set" to learn from data. Its principles are based on physical measurements and established algorithms.

9. How the ground truth for the training set was established:

• Not applicable. (See point 8).

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