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Wondfo Multi-Drug Urine Test Cup and Wondfo Multi-Drug Urine Test Panel are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Secobarbital, Oxazepam, Cocaine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Cannabinoids, Phencyclidine, Oxycodone, Buprenorphine, Methadone and Notriptyline in human urine at the cutoff concentrations of:

Configuration of the Wondfo Multi-Drug Urine Test Cup can consist of any combination of the above listed drug analytes.

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 or LC/MS is the preferred confirmatory method.

The test may yield positive results for the prescription drugs buprenorphine, oxazepam, oxycodone, and secobarbital when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs.

Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

For in vitro diagnostic use only. It is intended for over-the-counter and for prescription use.

Wondfo Multi-Drug Urine Test Cup and Wondfo Multi-Drug Urine Test Panel are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection Secobarbital, Oxazepam, Cocaine, Cannabinoids. Methamphetamine, Amphetamine, of Methylenedioxymethamphetamine, Phencyclidine, Oxycodone Buprenorphine, Methadone and Notriptyline in human urine samples. Wondfo Multi-Drug devices detect each of analytes on different strips.

A positive urine sample will not generate a colored-line for the specific drug tested in the designated region. A negative urine specimen or a urine sample containing Amphetamine, Secobarbital, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Phencyclidine, Oxycodone, Buprenorphine, Methadone and Notriptyline at the concentration below the designated cutoff levels will generate a colored line in the designated test region for the drug. To serve as a procedural control, a color line will always appear at the control region.

The provided document, K133968, is a 510(k) premarket notification for the Wondfo Multi-Drug Urine Test Cup and Panel, dated February 25, 2014. This document details the device's characteristics, intended use, and its substantial equivalence to predicate devices, but it does not contain information about specific acceptance criteria or the study that proves the device meets those criteria in the way typically expected for a diagnostic AI study.

The submission focuses on establishing substantial equivalence by demonstrating that the new multi-drug device combines individually cleared drug tests. The "Performance Characteristics" section explicitly states that the "Clearance of candidate device is for combining various individual drug tests into a multi-drug test. Analytical performance was established for each device in the submissions as stated below." This indicates that the performance data for each individual drug test component was referenced from prior 510(k) clearances, rather than a new, comprehensive study detailed within this specific document for the combined device meeting new acceptance criteria.

Therefore, for aspects of the prompt related to specific study details (sample size, data provenance, ground truth establishment, expert involvement, MRMC studies, standalone performance), the document points to external references (the prior 510(k) submissions for individual drug tests).

Here's a breakdown of the requested information based on the provided text, with clear indications where information is not present or refers to external documents:

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

The document does not explicitly state "acceptance criteria" in terms of specific sensitivity/specificity thresholds or concordance rates for the multi-drug device itself. Instead, it relies on the established performance of the individual drug tests that were previously cleared.

The "reported device performance" for the combined multi-drug test relates to its ability to perform qualitatively for each drug at specified cut-off levels, demonstrating substantial equivalence to predicate devices. The performance is implied to be acceptable if the individual components were acceptable.

*Note: Morphine is listed with two cut-off levels (300 ng/mL and 2000 ng/mL for "Morphine 2000 (OPI)") linked to different 510(k) numbers. The general indication for use lists 300 ng/mL.

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

This information is not detailed in the provided summary document directly for the multi-drug cup/panel. The document states "Analytical performance was established for each device in the submissions as stated below," and then lists the 510(k) numbers for individual drug tests. To find the sample sizes and data provenance, one would need to review each of those referenced 510(k) submissions (e.g., K121987 for Amphetamine, Secobarbital, Oxazepam).

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 detailed in the provided summary document. For drug screening tests like these, ground truth is typically established by definitive laboratory methods (e.g., GC/MS, LC/MS), not by human expert consensus or interpretation of the test device itself. The document explicitly states: "A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method."

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

This information is not applicable/detailed for this type of device and study. Adjudication methods are typically used in studies involving human readers and interpretations, often in imaging or clinical scenarios where expert opinion might differ. For a lateral flow immunochromatographic assay, the result (presence/absence of a line) is typically objective, and confirmation is done via definitive analytical methods.

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

No MRMC study was done or is applicable as this is a qualitative in vitro diagnostic device (IVD) for drug detection, not an AI-assisted diagnostic tool that human readers would interpret.

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

This device is a standalone diagnostic test (an immunochromatographic assay). Its performance is the direct result of the assay's chemical reactions, not an algorithm. The reading of the test involves human interpretation of a visual line, but the "performance" described refers to the chemical assay's ability to trigger that visual line based on drug concentration. The document emphasizes the need for confirmatory chemical methods (GC/MS, LC/MS).

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

The type of ground truth for these tests is definitive chemical analysis, specifically GC/MS (Gas Chromatography/Mass Spectrometry) or LC/MS (Liquid Chromatography/Mass Spectrometry). The document explicitly states: "A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method."

8. The sample size for the training set

This information is not applicable as this device is a chemical immunoassay, not an AI/machine learning algorithm that requires a "training set."

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

This information is not applicable as this device is a chemical immunoassay, not an AI/machine learning algorithm that requires a "training set."

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