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The Randox Laboratories Limited Cocaine Metabolite Assay is an in vitro diagnostic test for the qualitative determination of the major metabolite of cocaine, benzovlecgonine (BZG), in human urine. This is a competitive immunoassay. A cut-off of 300ng/ml benzoylecqonine has been established in line with SAMHSA recommendations.

This assay is for use only on the automated Evidence™ Analyser.

Note: This test provides only a preliminary analytical result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas Chromatography / Mass Spectrophotometry (GC/MS) is the preferred confirmatory method.

The Cocaine Metabolite Assay must only be used by suitably qualified laboratory personnel under appropriate laboratory conditions.

The Randox Laboratories Limited Drugs of Abuse Calibrators are liquid calibrators containing benzoylecgonine. There are 9 levels of calibrator.

They have been developed for use in calibration of the Evidence™ system.

These Drugs of Abuse Calibrators must only be used by suitably qualified laboratory personnel under appropriate laboratory conditions.

Evidence™ is an automated immunoassay analyser with dedicated software. It is for use with the Randox Evidence Cocaine Assay.

Evidence™ is an automated immunoassay analyser with dedicated software. It is for use with the Randox Evidence Cocaine Assay.

The provided text is a 510(k) premarket notification letter from the FDA for a Cocaine Metabolite Assay, Drugs of Abuse Calibrators & Evidence™ Automated Immunoassay Analyzer. This document primarily focuses on the regulatory approval and indications for use, rather than a detailed study report. As such, much of the requested information regarding specific acceptance criteria, study design, and performance metrics is not present in the provided text.

Based on the available information, here's what can be extracted and what cannot:

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

The document states: "A cut-off of 300ng/ml benzoylecqonine has been established in line with SAMHSA recommendations." This is a key acceptance criterion for the qualitative determination of cocaine metabolite. However, the document does not provide a specific table of acceptance criteria or reported device performance metrics (e.g., sensitivity, specificity, accuracy) from a study against these criteria.

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

This information is not available in the provided text.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not available in the provided text. The document refers to "Gas Chromatography / Mass Spectrophotometry (GC/MS) as the preferred confirmatory method," which implies a laboratory-based, objective ground truth, rather than expert interpretation.

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

This information is not available in the provided text.

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

This device is an automated immunoassay analyzer for detecting cocaine metabolites in urine. This is a diagnostic test performed by the machine, not an AI-assisted interpretation by human readers. Therefore, an MRMC comparative effectiveness study with human readers and AI assistance is not applicable to this type of device.

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

This would be the primary mode of operation for an "Automated Immunoassay Analyzer." The document explicitly states the device is "for use only on the automated Evidence™ Analyser" and "Evidence™ is an automated immunoassay analyser with dedicated software." While specific performance metrics for this standalone operation are not detailed in the provided text, the nature of the device implies a standalone performance evaluation would have been conducted as part of its development and FDA submission.

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

The preferred confirmatory method for the Cocaine Metabolite Assay is stated as Gas Chromatography / Mass Spectrophotometry (GC/MS). This is an objective, analytical laboratory method, not expert consensus or pathology.

8. The sample size for the training set

This information is not available in the provided text.

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

This information is not available in the provided text. However, it can be inferred that if a training set were used, its ground truth would also likely be established through GC/MS, consistent with the confirmatory method for the assay.

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