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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: Methamphetamine and Opiates

Immunoassay for the qualitative detection Methamphetamine and Opiate in urine

Here's a breakdown of the acceptance criteria and study information for the Phamatech At Home Drug Test (Model 9171) based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state pre-defined acceptance criteria with numerical targets. Instead, it justifies the device's performance through comparison to predicate devices and established laboratory methods. The "acceptance criteria" can be inferred from the reported performance which aligns with "substantially equivalent" to other commercially available tests and established lab methods.

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

• Clinical Sample Correlation Study: The text mentions "Correlations studies, using clinical specimens," but does not specify the sample size for this test set.
• Blind Labeled Spiked Study: The text mentions this study but does not specify the sample size.
• Consumer Study: The text mentions this study but does not specify the sample size.
• Data Provenance: The document does not explicitly state the country of origin of the data. It mentions "Clinical studies, performed at two independent laboratories," implying prospective data collection in a clinical setting. The "consumer study" also suggests prospective data collection in a home-use setting. It does not mention retrospective data.

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

The text does not explicitly mention "experts" in the context of establishing ground truth for the test set. Instead, it refers to:

• "Behring EMIT II (Cupertino, CA 95014) and GC/MS methodology" as the reference for comparison in the correlation studies. These are established laboratory methods, not individual experts.
• "professional users" in the clinical studies, but their specific qualifications are not detailed beyond "professional."

4. Adjudication Method for the Test Set

The provided information does not describe any adjudication method (e.g., 2+1, 3+1, none) for the test set. The ground truth was established by comparing the device's results to established laboratory methods (EMIT II and GC/MS) and observed outcomes in clinical and consumer studies.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, the document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. The studies focus on the device's performance in professional and lay user hands compared to reference methods, not on comparing human readers' performance with and without AI assistance. This device is an immunoassay test kit, not an AI-assisted diagnostic tool.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, in a way. The device itself is a qualitative immunoassay that provides a visual result. Its performance was evaluated against established laboratory methods (EMIT II and GC/MS), which can be considered a "standalone" evaluation of the assay's chemical reaction and detection capabilities, independent of human interpretation other than reading the reference method results. However, the "clinical studies" and "consumer study" inherently involve human interpretation of the device's results.

7. The Type of Ground Truth Used

The ground truth used was:

• Reference laboratory methods: Behring EMIT II and GC/MS methodology for the correlation studies.
• Observed outcomes: In the clinical and consumer studies, the "overall accuracy" implies comparison to the actual presence or absence of the target drugs, likely confirmed by the reference laboratory methods mentioned earlier or other established clinical assessments, though this is not explicitly detailed for these specific studies.

8. The Sample Size for the Training Set

The document does not mention a "training set" as this device is a qualitative immunoassay, not a machine learning or AI-based system that typically requires distinct training sets. Its development would involve assay optimization and validation rather than algorithmic training.

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

As there is no mention of a training set in the context of an algorithm or machine learning, this question is not applicable. The development of the immunoassay itself would involve establishing the expected reactivity of the assay components with known concentrations of target drugs.

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