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The Emit® II Plus Cannabinoid Assay is a homogeneous drugs-of-abuse enzyme immunoassay with a 20 ng/mL, 50 ng/mL (SAMHSA initial test cutoff level), or 100 ng/mL cutoff. The assay is intended for use in the qualitative and semiquantitative analyses of cannabinoids in human urine. Emit® II Plus assays are designed for use with a number of chemistry analyzers.

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The Syva Emit® II Plus Cannabinoid Assay is a homogeneous enzyme immunoassay intended for qualitative and semiquantitative analyses of cannabinoids in human urine, with three different cutoff protocols: 20 ng/mL, 50 ng/mL, and 100 ng/mL. The studies provided demonstrate the device's performance against established predicate methods.

1. Table of Acceptance Criteria and Reported Device Performance:

The document presents performance data for three protocols (20 ng/mL, 50 ng/mL, and 100 ng/mL). The acceptance criteria are implicitly defined by the reported performance relative to the predicate devices and the internal precision and sensitivity targets.

Protocol: 20 ng/mL

Protocol: 50 ng/mL

Protocol: 100 ng/mL

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

The document does not explicitly state the exact sample sizes for each test (e.g., comparative analysis, spiked sample recovery, precision studies). However, for the semiquantitative recovery, it mentions that "Negative human urine specimens were spiked with concentrations of cannabinoids (THC) at levels throughout the specified range." The exact number of specimens is not provided.

The data provenance is not specified regarding country of origin or whether it was retrospective or prospective. It is implied to be laboratory-based testing conducted by the manufacturer (Syva Company - Dade Behring Inc.).

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

This is an immunoassay device, and "experts" in the context of diagnostic imaging or clinical interpretation are not relevant here. The ground truth for comparative analysis, spiked sample recovery, and sensitivity is established by:

• Predicate methods: The Emit® II Cannabinoid Assays (20 ng, 50 ng, 100 ng) are used as the reference for comparative analysis.
• Known spiked concentrations: For spiked sample recovery and semiquantitative recovery, the ground truth is the precisely known concentration of cannabinoids added to the urine samples.
• Statistical analysis: Sensitivity is determined statistically based on the ability to distinguish a signal from 0 ng/mL.

Therefore, there were no human "experts" in a diagnostic interpretation sense used to establish ground truth for this type of in vitro diagnostic device.

4. Adjudication Method for the Test Set:

Not applicable. As an immunoassay, the device provides quantitative or qualitative results based on chemical reactions and optical detection. There is no human interpretation of results requiring adjudication. The comparison criteria are based on agreement with a predicate method or known spiked concentrations.

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:

Not applicable. This is an in vitro diagnostic device (immunoassay) and not an AI-powered diagnostic imaging tool or a system that involves human readers interpreting cases. Therefore, an MRMC study or assessment of human reader improvement with AI assistance is not relevant.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done:

The studies presented are inherently "standalone" in the sense that they evaluate the performance of the assay itself (chemical reactions and detection) without human interpretive intervention. The device's output (qualitative positive/negative or semiquantitative concentration) is directly compared to the ground truth.

7. The Type of Ground Truth Used:

The ground truth used in these studies consists of:

• Predicate Device Results: For comparative analysis, the results from the legally marketed Emit® II Cannabinoid Assays (20 ng, 50 ng, 100 ng) serve as the reference.
• Known Spiked Concentrations: For spiked sample recovery and semiquantitative recovery, the ground truth is the precisely known concentration of 11-nor-ΔTHC-9-carboxylic acid (or cannabinoids more generally) that was added to the negative human urine specimens.
• Statistical Thresholds: For sensitivity, the ground truth is a statistically defined limit of detection based on the response at 0 ng/mL.

8. The Sample Size for the Training Set:

The document does not specify a separate "training set" or its size. For an immunoassay, the "training" analogous to machine learning typically involves optimization of reagents, reaction conditions, and calibration curve development by the manufacturer during the assay development phase. The provided data focuses on the validation of the finalized assay.

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

Not applicable, as a distinct training set with established ground truth, similar to those used in AI or machine learning studies, is not described for this immunoassay device. The development process would involve internal controls, reference materials, and established analytical chemistry principles to optimize assay performance.

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