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A competitive binding immunoassay used for the qualitative determination of Cannabinoids in human urine. The device is visually read and intended for over the counter single use. The test has a cutoff of 50 ng/mL of Cannabinoids.

The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

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The provided text is a 510(k) FDA clearance letter for the "Wunder Test™" which is a Cannabinoid Test System. It does not contain a detailed study report with all the specific information requested in the prompt. Much of the information requested, such as sample sizes for training/test sets, ground truth establishment, and expert qualifications, is typically found in the submission's technical documentation, not the clearance letter itself.

However, based on the limited information available in this FDA clearance letter document, here's what can be extracted and inferred:

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

The provided document (FDAClearanceLetter_WunderTest.pdf) does not contain a table of acceptance criteria and reported device performance. It only states the device's intended use and cutoff.

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 document.

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 document. The ground truth for drug tests like this generally involves confirmatory methods, but the specifics of how that was established for the test set are not detailed here.

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

This information is not available in the provided document.

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 is an immunoassay and not an AI-based image analysis device. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable.

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

The device is described as "visually read" and "intended for over the counter single use." This indicates that it is a standalone test performed by an individual, not an algorithm requiring human intervention after an automated analysis. The performance would be the direct result of the visual interpretation of the test based on the chemical reaction.

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

The document states: "A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method." This strongly suggests that Gas Chromatography-Mass Spectrometry (GC/MS) was used as the ground truth for confirming cannabinoid presence and concentration in the study.

8. The sample size for the training set

This information is not available in the provided document. For an immunoassay, the "training set" would typically refer to samples used during the development and optimization of the assay's chemical components and read-out parameters, rather than a machine learning training set.

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

This information is not available in the provided document. Similar to the test set, it would likely involve GC/MS or a comparable highly accurate reference method.

Summary of what is available / could be inferred:

• Device Name: Wunder Test™
• Indication for Use: Qualitative determination of Cannabinoids in human urine, visually read, intended for over-the-counter single use.
• Cutoff: 50 ng/mL of Cannabinoids.
• Ground Truth Method for Confirmation: GC/MS (preferred confirmatory method).
• Type of Study: Implied to be a standalone performance study.
• AI Involvement: None, as this is a visually read immunoassay.

Conclusion:

The provided FDA clearance letter offers limited details regarding the specifics of the underlying study's methodology, particularly regarding sample sizes, expert involvement, and detailed acceptance criteria or performance metrics. This information would typically be found in the 510(k) submission itself, which is a much larger and more detailed technical document. The letter serves as an official communication of the FDA's decision based on its review of that submission.

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