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The SYNCHRON Systems Cannabinoid 20 ng Reagent, in conjunction with the SYNCHRON Systems THC Urine Calibrators, is intended for use in the qualitative determination of cannabinoids in human urine samples. This assay is designed for use with the family of SYNCHRON Systems, which include analyzers such as the SYNCHRON® CX4, CX@4CE, CX4 DELTA, CX5, CX5CE, CX5 DELTA, CX7, and CX7 DELTA Systems.

The SYNCHRON Cannabinoid 20 ng Reagent is an enzyme immunoassay reagent test kit for the SYNCHRON Systems and provides a rapid screening procedure for determining the presence of cannabinoids and it's metabolites in urine. It is designed to complement the current panel of CX Drugs of Abuse Assays, previously cleared by FDA. The kit consists of reagent and calibrators.

Acceptance Criteria and Device Performance for BECKMAN SYNCHRON® Systems Cannabinoid 20 ng Reagent

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state formal "acceptance criteria" with numerical thresholds for performance metrics. Instead, it describes "equivalence" to a predicate device through various performance studies. Therefore, the "acceptance criteria" are inferred from the demonstrated performance that supports substantial equivalence.

2. Sample Size and Data Provenance for Test Set

• Sample Size for Test Set: 136 samples
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The document refers to "method comparison, stability, and imprecision experiments" and "results obtained from the SYNCHRON Systems Cannabinoid 20 ng Reagent to the Emit II Reagent." This suggests the samples were likely collected for the purpose of comparing the new device to the predicate. The absence of specific patient demographics or collection details prevents a definitive classification of retrospective or prospective.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. The study primarily relies on the Emit II Cannabinoid Reagent as the comparative standard, implying its results served as the reference for determining relative sensitivity and specificity.

4. Adjudication Method for Test Set

• Adjudication Method: Not specified. The comparison is stated as "SYNCHRON Cannabinoid 20 ng Reagent vs Emit II," suggesting a direct comparison without an explicit adjudication process beyond the Emit II result itself. Discordant results are noted (1), but the method for resolving or adjudicating this discrepancy is not detailed.

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

• MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This study focuses on the performance of a diagnostic reagent rather than the interpretation of medical images or data by multiple human readers.

6. Standalone Performance Study (Algorithm Only)

• Standalone Study: Yes, a standalone performance study was done. The reported performance metrics (Overall Agreement, Relative Sensitivity, Relative Specificity, Imprecision) are for the SYNCHRON Cannabinoid 20 ng Reagent operating independently. The "human-in-the-loop" aspect for this type of device would primarily involve sample collection and proper operation of the SYNCHRON analyzer, rather than interpretation of results that influence the device's fundamental performance.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth for evaluating the SYNCHRON device's performance was established using a predicate device's results, specifically the Emit II Cannabinoid 20 ng Assay. This is referred to as "Relative Sensitivity" and "Relative Specificity" against the predicate.

8. Sample Size for Training Set

• Sample Size for Training Set: Not explicitly stated. The document describes the device as a "reagent test kit" for an "enzyme immunoassay reagent." Such immunoassays typically do not involve a "training set" in the context of machine learning algorithms. The development process would involve formulation, optimization, and validation using various samples, but these are not typically referred to as a "training set" in this context. The study focuses on validation against a predicate using a specified test set.

9. How Ground Truth for Training Set Was Established

• Ground Truth for Training Set: As stated above, the concept of a "training set" with established ground truth, as understood in machine learning, does not directly apply to this type of immunoassay reagent. The "ground truth" used for initial development and optimization would have been based on known concentrations of cannabinoids in spiked samples and/or comparison to established reference methods or previously validated assays, similar to how the product was later validated against the Emit II predicate. The document does not provide details on this development phase.

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