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The Amedica Drug Screen Cocaine Test is an in vitro diagnostic test for the rapid detection of benzoylecgonine in human urine at a cutoff of 300 ng/m1. This test kit is used to obtain a visual, qualitative result and is intended for professional use. It is not intended for over the counter sale.

This assay provides only a preliminary result. A more specific alternative chemical method is needed to obtain a confirmed result.

Membrane based one-step, lateral flow, competitive immunoassay use colloidal gold for visual detection. The test cutoff is 300 ng/ml.

Acceptance Criteria and Study for Amedica Drug Screen Cocaine Test

The provided document describes the Amedica Drug Screen Cocaine Test, an immunochromatographic assay for the rapid detection of benzoylecgonine in human urine. The test has a cutoff concentration of 300 ng/ml.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" with specific thresholds for performance metrics. However, it implicitly defines success through its claim of "substantial equivalence" to a predicate device and a ">%96 agreement with GC/MS results."

2. Sample Size and Data Provenance

• Test Set Sample Size: The document does not specify the exact number of clinical specimens used in the "correlation study" or the "clinical site study."
• Data Provenance: The studies were conducted using "blind-labeled clinical specimens" and "at two certified laboratories." The country of origin is not explicitly stated but can be inferred to be the USA, given the manufacturer's address (Hayward, CA) and the FDA submission. The studies were retrospective as they used existing clinical specimens that had already been measured by GC/MS.

3. Number of Experts and Qualifications for Ground Truth

• The document does not specify the number of experts or their qualifications used to establish the ground truth for the test set.
• However, the ground truth was established by Gas Chromatography/Mass Spectrometry (GC/MS), which is considered a highly accurate and definitive method for drug detection. The "experts" in this context would be the technicians or analysts performing and interpreting the GC/MS results, who are typically highly trained in analytical chemistry.

4. Adjudication Method

• The document does not describe an adjudication method for the test set. The comparison was primarily against GC/MS results.

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

• No MRMC comparative effectiveness study was done as described in the provided text. The study involved comparing the device's results with GC/MS and a predicate device, not measuring improvements in human reader performance with or without AI assistance. This device is a rapid diagnostic test, not an AI-assisted diagnostic tool.

6. Standalone Performance Study

• Yes, a standalone performance study was done. The "correlation study using blind-labeled clinical specimens that have been measured by GC/MS" evaluated the Amedica Drug Screen Cocaine Test's performance (specifically, its agreement with GC/MS) independently. The "clinical site study" also demonstrated the device's ability to be used by professionals for detection, indicating its standalone functionality. The "Amedica Drug Screen Cocaine Test can be use by professionals to obtain a visual, qualitative detection of drugs of abuse" indicates that the test itself provides a result without requiring human interpretation beyond reading the visual bands.

7. Type of Ground Truth Used

• The primary ground truth used was Gas Chromatography/Mass Spectrometry (GC/MS) results. This is a highly accurate and analytical chemical method considered the gold standard for confirming the presence and concentration of drugs and their metabolites.

8. Sample Size for the Training Set

• The document does not specify a training set sample size. This type of rapid diagnostic test typically does not involve a "training set" in the context of machine learning algorithms. The development involves optimizing the biochemical reactions and components rather than training an algorithm.

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

• Since there's no mention of a "training set" in the machine learning sense, this question is not directly applicable. If considering the "development" or "optimization" phase of the test, the ground truth for fine-tuning the assay's chemical parameters would likely involve a combination of spiked samples with known concentrations of benzoylecgonine and possibly preliminary testing with clinically characterized urine samples analyzed by methods like GC/MS to ensure the assay performs as expected for the target cutoff.

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