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Rapid Urine Fentanyl (FYL) Test Strip is a rapid, screening test for the qualitative detection of Fentanyl (FYL) in human urine at the cut-off concentration of 1 ng/mL. For in vitro diagnostic use only. This assay provides only a preliminary analytical test result. To obtain a confirmed analytical result, a more specific alternative chemical method must be used. GC/MS or LC/MS is the preferred confirmatory method. Rapid Urine Fentanyl (FYL) Test Dipcard is a rapid, screening test for the qualitative detection of Fentanyl (FYL) in human urine at the cut-off concentration of 1 ng/mL. For in vitro diagnostic use only. This assay provides only a preliminary analytical test result. To obtain a confirmed analytical result, a more specific alternative chemical method must be used. GC/MS is the preferred confirmatory method.

Rapid Urine Fentanyl (FYL) Test Strip and Rapid Urine Fentanyl (FYL) Test Dipcard are competitive binding, lateral flow immunochromatographic assays for qualitatively the detection of fentanyl at or above the cut-off concentration of 1 ng/mL. The tests can be performed without the use of an instrument. Test Strip and Test Dipcard use identical test strips made with same chemical formulation and manufacturing procedures.

The provided text describes a 510(k) premarket notification for a Rapid Urine Fentanyl (FYL) Test Strip and Dipcard. The device is a rapid screening test for the qualitative detection of Fentanyl in human urine at a cut-off concentration of 1 ng/mL. The approval is an addition of an OTC (Over-The-Counter) claim to a previously cleared prescription device (K231904).

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

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

The document doesn't explicitly state "acceptance criteria" as a separate table. However, the performance is demonstrated through a lay user study, with the implicit acceptance being a high agreement with the confirmed sample concentrations.

2. Sample size used for the test set and the data provenance

• Test Set Sample Size: The lay user study used 360 lay persons. For each device (Test Strip and Test Dipcard) and each concentration level, 30 determinations were made.
• Data Provenance: The text does not explicitly state the country of origin. The study was conducted at "three intended user sites." The study design indicates it was a prospective study where participants tested blinded, randomized samples.

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

The text states: "The concentrations of samples were confirmed by LC/MS." It does not specify the number of experts or their qualifications for this confirmation. LC/MS (Liquid Chromatography-Mass Spectrometry) is an analytical chemistry technique, and its use implies that the ground truth was established through a laboratory method, likely performed by trained laboratory personnel.

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

The text does not mention an adjudication method for the lay user results. Each participant's interpretation of their test result was recorded, and the "Agreement (%)" was calculated based on these individual interpretations compared to the known sample concentration.

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 section is not applicable as the device is a rapid, screening test for drug detection and does not involve AI or human reader interpretation in the context of image analysis or diagnostic assistance. The "readers" in this case are the lay users interpreting the test strip/dipcard result.

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

This section is not applicable as the device is a manual, rapid test. The "standalone" performance is essentially what the lay users demonstrated in their interpretation of the test results themselves. There is no algorithm or automated reading discussed.

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

The ground truth for the test set samples was established by LC/MS (Liquid Chromatography-Mass Spectrometry), which is a highly specific and sensitive analytical chemical method for confirming the concentration of substances. The text explicitly states: "The concentrations of samples were confirmed by LC/MS."

8. The sample size for the training set

The document does not provide information about a "training set" for the device itself because it is an immunochromatographic assay, not an AI/machine learning device. The performance characteristics are inherent to the chemical formulation and manufacturing procedures. The 510(k) summary references "analytical performance in predicate K231904" and "studies in predicate K231904," which would include the foundational analytical performance data.

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

As there is no "training set" in the context of AI/machine learning, this question is not applicable. The analytical performance and design of this type of device are established through various laboratory studies (e.g., specificity, sensitivity, precision, cross-reactivity) using reference standards and confirmed samples, as would have been documented for the predicate device (K231904).

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