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The LYHER® Urine Multi-Drug Test Kit (Cup), LYHER® Urine Multi- Drug Test Kit (Cassette), and LYHER® Urine Multi-Drug Test Kit (Dipcard) are rapid lateral flow immunoassays for the qualitative detection of d-Amphetamine, d-Methamphetamine, Benzoylecgonine, Morphine, Phencyclidine and THC-COOH in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows:

The single or multi-test panels can consist of the above listed analytes in any combination, up to a maximum of 6 analytes. The drug screen tests are intended for prescription use only. The tests provide only a preliminary result. A more specific alternative chemical method should be used in order to obtain a confirmed presumptive result. Gas Chromatography/Mass Spectrometry (GC/MS), Liquid Chromatography / Mass Spectrometry (LC/MS) and their tandem mass-spectrometer versions are the preferred confirmatory methods. Careful consideration and judgment should be applied to any drugs of abuse screen test result, particularly when evaluating preliminary positive results.

The LYHER® Urine Multi-Drug Test Kit(Cup), LYHER® Urine Multi-Drug Test Kit(Cassette), LYHER® Urine Multi-Drug Test Kit(Dipcard) are immunochromatographic assays that use a lateral flow system for the qualitative detection of d-Amphetamine, d-Methamphetamine, Benzoylecgonine, Morphine, Phencyclidine and THC-COOH in human urine. The LYHER® Urine Multi-Drug Test Kit (Cup) device consists of 25 or 40 cup devices and a package insert. The LYHER® Urine Multi-Drug Test Kit (Dipcard) device consists of 10/15/20/25 Dip Card devices, a package insert. The LYHER® Urine Multi-Drug Test Kit (Cassette) device consists of 10/15/20/25 cassette devices, 10/15/20/25 droppers, a package insert.

The provided text describes the 510(k) summary for the LYHER® Urine Multi-Drug Test Kits, which are rapid lateral flow immunoassays for the qualitative detection of several drugs in human urine. The study presented is a method comparison study to demonstrate substantial equivalence to a predicate device, not a study to establish acceptance criteria for a new AI/ML device. Therefore, much of the requested information (e.g., AI/ML specific details, number of experts, adjudication methods, MRMC study, sample size for training set) is not applicable or directly available from this document because it pertains to a different type of device and study.

However, based on the provided text, I can extract information related to the acceptance criteria (cut-off values) and the performance of the device in relation to these criteria.

1. Table of acceptance criteria and the reported device performance:

The acceptance criteria for these devices are defined by the cut-off concentrations for each drug. The reported device performance is demonstrated through in-house method comparison studies using various concentrations around these cut-offs. The precision studies indicate that samples at or below -25% of the cut-off were consistently negative, and samples at or above +25% of the cut-off were consistently positive. The method comparison tables provide more detailed performance around the cut-off by showing the number of positive and negative results at different concentration ranges compared to LC/MS results.

Here is a summary table, combining the listed cut-off values and inferring the performance based on the precision study description:

Note: The precision study states that "The test results of the specimens at the concentrations at and below -25% of the cut off obtained by all the three personnel were all negative while the test results of the specimens at the concentration at and above +25% of the cut off value were all positive." This broadly defines the performance against the cut-off. The method comparison tables offer more granular data but are too extensive to fully replicate here for each drug and each device type. These tables show that most results within the -25% to +25% cut-off range are discordant (either positive by LC/MS and negative by device, or vice-versa), which is expected for qualitative tests around the cut-off.

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

• Sample Size for Precision Studies: For each drug and each concentration (-100%, -75%, -50%, -25%, +25%, +50%, +75%, +100% cut off), 50 replicates were analyzed by each of 6 operators using three lots of the product. This means for one drug and one concentration, there were 50 replicates * 3 lots * 6 operators = 900 tests. Across 8 concentrations, this would be 7,200 tests per drug. Since there are 6 drugs, the total number of tests in the precision study is substantial.
• Sample Size for Method Comparison Studies:
  • AMP Cassettes, Dipcards, Cups: 43 negative urine samples, and a varying number of samples at different concentrations relative to the cut-off (e.g., for AMP Cassettes, 12 samples in -50% cut offcut off, 23 samples in Cut off+50%cut off, 17 samples >+50%cut off). The total number of unique samples is not explicitly stated but can be inferred by summing up the categories for each operator. For AMP Cassettes, for Operator 1, this totals 43 (negative) + 12 (+25%) + 17 (>+25%) = 95 unique samples. This was done for 3 operators for each of the 3 device types (cassette, dipcard, cup).
  • Similar sample distributions are provided for COC, MET, OPI, PCP, and THC across the cassette, dipcard, and cup formats.
• Data Provenance: The method comparison studies were performed "in-house" and used "unaltered clinical samples." The document does not specify the country of origin of the data, but the submitter is Hangzhou Laihe Biotech Co., Ltd., China. The studies are assumed to be retrospective as they involve "unaltered clinical samples" compared to a reference method.

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

This information is not applicable as the device is an in-vitro diagnostic test. "Experts" in the context of IVD performance usually refer to the highly accurate reference method. In this case:

• Ground Truth Method: Gas Chromatography/Mass Spectrometry (GC/MS), Liquid Chromatography / Mass Spectrometry (LC/MS) and their tandem mass-spectrometer versions are preferred confirmatory methods, and LC/MS was used to confirm drug concentrations in the precision studies and as the comparator (ground truth) in the method comparison studies.
• Number/Qualifications of Experts: The document does not refer to human experts establishing ground truth for individual samples, but rather mentions "three laboratory assistants" who "ran samples" for the method comparison studies and "6 operators" for the precision studies. These personnel are performing the tests, not establishing the ground truth. The ground truth is established by chemical analysis (LC/MS).

4. Adjudication method for the test set:

This information is not applicable as the device is an in-vitro diagnostic test and the ground truth is established by a quantitative chemical analysis (LC/MS), not through human expert consensus or qualitative review that would require adjudication.

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 not applicable. The device is a rapid lateral flow immunoassay, not an AI/ML powered device, and no human reader assistance is involved in the interpretation beyond visual reading of the test lines. Therefore, an MRMC study related to AI assistance is not relevant.

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

This is not applicable. The device is not an algorithm or AI system. It is a physical immunoassay kit.

7. The type of ground truth used:

The ground truth used for establishing performance and comparing results in the method comparison study is LC/MS (Liquid Chromatography / Mass Spectrometry), which is a highly accurate chemical method for quantifying drug concentrations in urine.

8. The sample size for the training set:

This is not applicable as the device is not an AI/ML system and does not have a "training set" in that context. The device's performance is inherently based on its biochemical design.

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

This is not applicable for the same reason as above. If considering the "training" analogous to R&D and optimization of the immunoassay, the performance characteristics (e.g., specificity, cross-reactivity) would have been established using controlled spiking experiments and comparison to reference methods like LC/MS. The document mentions "These samples were prepared by spiking drug in negative samples. Each drug concentration was confirmed by LC/MS" in the precision studies, which indicates how known concentrations were established for performance evaluation.

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