Search Results

A home drug screening, and if needed, confirmation service. This kit provides a preliminary result for the detection/presence of the following drugs of abuse in urine: THC (marijuana).

Immunoassay for the qualitative detection of THC in urine.

Here's an analysis of the provided text to extract the acceptance criteria and study information for the At Home Drug Test (Model 9079):

Acceptance Criteria and Device Performance

The document doesn't explicitly state "acceptance criteria" in a tabulated format with specific targets. However, based on the performance results reported, the implicit acceptance criteria appear to be high accuracy and correlation with established methods.

Study Details

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

   • Clinical Specimens (Correlation Studies): The exact number of clinical specimens for the >99% correlation study is not explicitly stated.
   • Clinical Studies (Professional Users): The number of clinical specimens for the ">98% overall accuracy" study is not explicitly stated.
   • Consumer Study: The consumer study involved 943 interpretations, specifically for cocaine detection, with 915 accurate results. The overall sample size for the consumer study for THC is not specified but it states "excellent overall accuracy".
   • Data Provenance: The document does not specify the country of origin. It mentions "clinical studies, performed at two independent laboratories" and comparisons to predicate devices like Behring EMIT II (Cupertino, CA 95014), but no origin for the specimens themselves. The studies appear to be prospective as they were conducted to demonstrate performance for regulatory submission.

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

   • The document implies that GC/MS methodology and comparison to the Behring EMIT II (another commercially available immunoassay) were used as the gold standard for establishing ground truth in the correlation studies. These are laboratory-based, objective methods rather than relying on human expert interpretation for individual cases.
   • For the "clinical studies" with professional users, it's implied that the results of the Behring EMIT II and GC/MS were the ground truth against which the "professional users" results were compared. There is no mention of human experts specifically establishing ground truth for the test set; rather, they used established laboratory methods.

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

   • No adjudication method (like 2+1 or 3+1 consensus) is described, as the ground truth was established by objective laboratory methods (GC/MS, Behring EMIT II) rather than subjective expert review.

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:

   • This is not an AI device. Therefore, no MRMC comparative effectiveness study comparing human readers with and without AI assistance was performed or is relevant.

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

   • This is a standalone diagnostic device. The performance data presented (correlation, accuracy by professional users, and accuracy by consumer users) reflects the device's performance directly, without a human-in-the-loop in the sense of an AI interpreting images for a human. The "professional users" and "consumer users" studies assess the device's standalone performance in the hands of its intended operators.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The primary ground truth used was objective laboratory methods:
     • GC/MS (Gas Chromatography/Mass Spectrometry): A highly accurate and commonly accepted reference method for drug confirmation.
     • Behring EMIT II: A widely accepted immunoassay for drug screening, serving as a predicate device for comparison.

7. The sample size for the training set:

   • This document describes performance studies, not a machine learning model. Therefore, there is no "training set" in the context of AI. The performance studies used clinical specimens and spiked samples to validate the device's accuracy and correlation.

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

   • As there is no AI training set, this question is not applicable. The performance was evaluated against established laboratory methods.

Ask a specific question about this device