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The Multiplate 5.0 aggregometer is intended for in vitro use to measure platelet aggregation in response to Arachidonic acid or ADP in citrated whole blood samples for the qualitative assessment of platelet function.

The ADPtest reagent is a lyophilized preparation of adenosine-5-diphosphate for in vitro diagnostic use to measure platelet aggregation for the qualitative assessment of platelet function. For professional laboratory use only.

The ASPItest reagent is a lyophilized preparation of arachidonic acid (AA) for in vitro diagnostic use to measure platelet aggregation for the qualitative assessment of platelet function. For professional laboratory use only.

For use as an assayed quality control verification of the resistance measure of impedance aggregometry.

The Multiplate® 5.0 measures platelet function in whole blood samples using electrical impedance. The Multiplate technology employs multiple electrodes in a disposable test cell. Four electrodes form two independent sensor units allowing for two measurements on the same sample. Five independent channels of the instrument allow for testing of multiple reagents or samples simultaneously.

The instrument provides a five channel aggregometer and an integrated computer system with associated software and is connected to a computer screen, keyboard, mouse, and an electronic pipette. The software is used for data collection and is not used for diagnosis or treatment.

Currently, two test reagents (ADP and Arachidonic acid) are available that activate platelets through specific platelet membrane receptor/signal transduction pathways in order to measure platelet function or alterations in function.

The Multiplate 5.0 device measures platelet aggregation in whole blood samples. This device report focuses on its performance compared to a predicate device (Chrono-log Model 700) and its ability to assess platelet function.

Here's a breakdown of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria in terms of numerical thresholds for agreement, sensitivity, or specificity. Instead, the "Performance" section reports the observed agreement and diagnostic accuracy against the predicate device and physician panel review, respectively. Therefore, the reported performance metrics can be considered the de facto "acceptance criteria" against which the device passed for substantial equivalence demonstration.

2. Sample Size and Data Provenance for the Test Set

• Sample size for agreement study (Test Set 1): 171 patients.
• Sample size for sensitivity/specificity study (Test Set 2): 91 patients.
• Data Provenance: The document states "Multi-center studies were run," implying prospective data collection across multiple sites. There is no explicit mention of the country of origin of the data, but the submitting company is based in Germany. The data is implicitly prospective, as it was collected to compare the Multiplate 5.0 to the predicate device and against clinical status.

3. Number of Experts and Qualifications for Ground Truth (Test Set)

• Number of experts: The document mentions a "physician panel" for establishing Platelet Function Status for the sensitivity/specificity study. The exact number of physicians on this panel is not specified.
• Qualifications of experts: Not specified beyond being a "physician panel." Their specific specialty (e.g., hematologist, critical care physician) or years of experience are not provided.

4. Adjudication Method (Test Set)

• For the agreement study with the predicate device, there was no independent adjudication method described. The comparison was direct measurement of the Multiplate 5.0 against the Chrono-log Model 700.
• For the sensitivity/specificity study, the "Platelet Function Status of each sample was based upon a physician panel's review of each patient's clinical history." This implies a form of consensus or collective decision-making by the panel, but the specific adjudication method (e.g., unanimous, majority vote, 2+1) is not detailed.

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

No, an MRMC comparative effectiveness study that assesses human readers' improvement with vs. without AI assistance was not conducted. This device is an automated platelet aggregation system, not an AI diagnostic tool that assists human interpretation of images or data. The studies involved a direct comparison between devices or device output against clinical ground truth.

6. Standalone Performance Study (Algorithm Only)

Yes, a standalone study was performed. The reported performance metrics (agreement, sensitivity, specificity) reflect the performance of the Multiplate 5.0 device (the "algorithm only," as it's an automated system) without human interpretation or intervention in the measurement process itself. The software for data collection is explicitly stated as "not used for diagnosis or treatment," reinforcing that the device itself generates the results.

7. Type of Ground Truth Used

• For agreement studies: The ground truth was the results obtained from the predicate device (Chrono-log Model 700).
• For sensitivity and specificity studies: The ground truth was the "Platelet Function Status" based on a physician panel's review of each patient's clinical history. This can be categorized as expert consensus / clinical diagnosis.

8. Sample Size for the Training Set

The document does not specify a sample size for a training set. Given that this is a 510(k) submission for a device measuring electrical impedance (a well-established physical principle) rather than an AI/machine learning algorithm that requires extensive training, it's highly probable that there wasn't a "training set" in the modern machine learning sense. The device's operational parameters would likely be derived from engineering principles and validation, rather than data-driven training.

9. How Ground Truth for the Training Set Was Established

As no "training set" is mentioned or implied for a machine learning context, the concept of establishing ground truth for a training set does not apply in this document. The device operates based on physical principles and pre-defined reagents, with performance validated against clinical samples and a predicate device.

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