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This device is a one-step intended to provide qualitative rapid detection of methylenedioxymethamphetamine (MDMA, or Ecstasy, XTC) in human urine at a cut-off concentration of 500ng/ml. It is for health care professional use only.

This test provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

A one-step lateral flow chromatographic immunoassay. The test strip in the device includes 1) a conjugate pad containing colloidal gold coupled with mouse anti-MDMA antibody; 2) nitrocellulose membrane containing a test line (T line) coated with MEMA-BSA and a control line (C line) coated with Goat anti mouse antibody.

Here's a summary of the acceptance criteria and the study details for the Instant-View™ MDMA (Ecstasy, XTC) Urine Test, based on the provided text:

Acceptance Criteria and Device Performance

Study Details

• 1. Sample size used for the test set and the data provenance:

  • Sample Size: 80 clinical urine specimens.
  • Data Provenance: Retrospective, with no specific country of origin mentioned beyond "clinical urine specimens."

• 2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

  • This information is not provided in the text. The ground truth was established by Gas Chromatography/Mass Spectrometry (GC/MS) data, which is an analytical method, not directly dependent on expert interpretation in the same way as, for example, reading a medical image.

• 3. Adjudication method for the test set:

  • None stated directly for test set results. The comparison was against objective GC/MS data. Discrepancies were noted but no human adjudication process for those discrepancies is described.

• 4. 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:

  • No. This device is a rapid diagnostic immunoassay, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study is not applicable.

• 5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

  • Yes, for the accuracy study. The device itself produced results that were then compared to the GC/MS ground truth. While it's a qualitative test, the performance metrics (agreement percentage) reflect the device's standalone capability.

• 6. The type of ground truth used:

  • Pathology/Outcomes Data: The ground truth was established using Gas Chromatography/Mass Spectrometry (GC/MS) data. This is a highly accurate and commonly accepted confirmatory method for drug testing, often considered the gold standard.

• 7. The sample size for the training set:

  • Not explicitly stated. The document describes "accuracy studies" and "reproducibility studies" but does not differentiate a specific "training set" for the device, as it is a lateral flow immunoassay that operates based on a fixed chemical design, not a machine learning algorithm.

• 8. How the ground truth for the training set was established:

  • Not applicable for a training set as the device is a chemical immunoassay, not an algorithm that undergoes a training phase with labeled data in the conventional sense of AI. The performance validation was against GC/MS data on clinical specimens.

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