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The LYHER® Oral fluid Multi-Drug Test Kit (Cube) is a rapid lateral flow immunoassay for the qualitative detection of d-Amphetamine, d-Methamphetamine, Benzoylecgonine, Morphine, Phencyclidine and Delta-9-Tetrahydrocanabinol in human oral fluid. 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 insted analytes in anycombination, up to a maximum of 6 analytes. The tests provide only a preliminary result. A more specific alternate chemical must be used in order to obtain a confirmed analytical test 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® Oral fluid Multi-Drug Test Kit (Cube) is an immunochromatographic assay that uses a lateral flow system for the qualitative detection of d-Amphetamine, d-Methamphetamine, Benzoylecgonine, Morphine, Phencyclidine and Delta-9-Tetrahydrocannabinol in human oral fluid. The LYHER® Oral fluid Multi-Drug Test Kit (Cube) device consists of a cube device, an oral fluid collection swab and a package insert.

The document describes the analytical performance studies for the LYHER® Oral fluid Multi-Drug Test Kit (Cube), a rapid lateral flow immunoassay. The device is designed to detect d-Amphetamine, d-Methamphetamine, Benzoylecgonine, Morphine, Phencyclidine, and Delta-9-Tetrahydrocannabinol in human oral fluid.

Here's a breakdown of the requested information based on the provided text:

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

The document does not explicitly state "acceptance criteria" as a pass/fail threshold for performance, but rather presents the results of precision-reproducibility studies across various concentrations relative to the cut-off. The performance is summarized by the number of positive and negative results at each concentration.

To construct a table of "acceptance criteria" (inferred as target performance, though not explicitly defined as such) and reported performance, we can focus on the precision-reproducibility studies around the cut-off and the comparison study data. For the comparison study, the implicit acceptance criterion is that the device accurately identifies samples as positive or negative relative to the LC/MS confirmation.

Inferred Acceptance Criteria (Conceptual) and Reported Device Performance

Note on Acceptance Criteria: The document provides raw performance data. For a qualitative immunoassay, the "acceptance criteria" are usually demonstrated by a high rate of negativity well below the cutoff, a high rate of positivity well above the cutoff, and a predictable transition zone around the cutoff concentration. The data presented supports this.

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

• Test Set Sample Size:

  • Precision-Reproducibility-Cut-Off Study: For each drug, 9 concentration levels were tested. For each concentration, there were 2 runs per day for 30 days, across 3 device lots, and by 3 operators.
    • This means 9 concentrations * 2 runs/day * 30 days * 3 lots * 3 operators = 4860 total tests per drug analyte for the precision study.
    • Each concentration within each operator/lot combination was tested 60 times (2 runs/day * 30 days). So for each specific concentration, lot, and operator, n=60.
  • Comparison Studies (Method Comparison):
    • Negative oral fluid: 360 samples (across all operators and sites for each drug).
    • Positive oral fluid at various ranges:
      • <-50% cut off: For D-Amphetamine, 93 samples. For Cocaine, 69 samples. For d-Methamphetamine, 63 samples. For Morphine, 57 samples. For Phencyclidine, 51 samples. For Delta-9-Tetrahydrocannabinol, 93 samples.
      • -50% cut off - cut off: For D-Amphetamine, 74 samples. For Cocaine, 83 samples. For d-Methamphetamine, 70 samples. For Morphine, 84 samples. For Phencyclidine, 109 samples. For Delta-9-Tetrahydrocannabinol, 96 samples.
      • Cut off - +50% cut off: For D-Amphetamine, 180 samples. For Cocaine, 172 samples. For d-Methamphetamine, 164 samples. For Morphine, 183 samples. For Phencyclidine, 170 samples. For Delta-9-Tetrahydrocannabinol, 172 samples.
      • >+50% cut off: For D-Amphetamine, 183 samples. For Cocaine, 186 samples. For d-Methamphetamine, 189 samples. For Morphine, 180 samples. For Phencyclidine, 192 samples. For Delta-9-Tetrahydrocannabinol, 195 samples.
    • The total number of samples for the comparison study for each drug is 360 (negatives) + (sum of the positive ranges for that drug). For example, for D-Amphetamine: 360 + 93 + 74 + 180 + 183 = 890 samples. This applies similarly to other drugs.

• Data Provenance: The document states "Method comparison studies for the LYHER Oral fluid Multi-Drug Test Kit(Cube) were performed at three testing sites with three operators at each site." The location of these sites is not explicitly mentioned (e.g., country of origin), but the submitter is based in China. The data origin is prospective as samples were prepared by spiking known concentrations into negative oral fluid for analytical studies.

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

• Ground Truth Establishment: The ground truth for the test set for both the precision and comparison studies was established by Laboratory Confirmed Concentrations, specifically using LC/MS (Liquid Chromatography/Mass Spectrometry). For the precision study, it states: "Each drug concentration was confirmed by LC/MS." For the method comparison studies, it states: "Operators tested the samples using the candidate device and the results were compared to LC/MS results."
• Number of Experts/Qualifications: LC/MS is a laboratory analytical method, not reliant on subjective expert interpretation like radiological imaging. Therefore, there were no "experts" in the sense of human annotators (e.g., radiologists) involved in establishing the ground truth via consensus or adjudication. The "experts" would be the qualified laboratory personnel performing and interpreting the LC/MS results, whose qualifications are implicit given the professional standards for such testing.

4. Adjudication method for the test set

• Since LC/MS is used to establish quantitative drug concentrations, and the device provides a qualitative "positive" or "negative" result based on a defined cutoff, there is no expert adjudication method (like 2+1, 3+1) mentioned or necessary. The device's result is compared directly to the LC/MS result relative to the established cut-off.

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 question is not applicable to this device. This is a qualitative diagnostic test (immunoassay) for drug detection in oral fluid, not an AI-powered image analysis device that assists human readers. The "operators" mentioned are performing the test, not interpreting complex medical images.

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

• This device is a standalone test (a rapid lateral flow immunoassay), essentially an "algorithm only" in the sense that its chemical reactions produce a visual result (line presence/absence). Human interaction involves collecting the sample, applying it to the device, and visually interpreting the presence or absence of test lines. There isn't a separate "algorithm" that operates outside of the device itself to interpret the results. The performance data presented measures the device's inherent analytical accuracy against known concentrations and LC/MS.

7. The type of ground truth used

• The ground truth used for both precision and comparison studies was laboratory-confirmed drug concentrations via LC/MS (Liquid Chromatography/Mass Spectrometry). This is a highly accurate and quantitative analytical method, considered a gold standard for drug detection and quantification.

8. The sample size for the training set

• This device is a lateral flow immunoassay, not a machine learning or AI-based device that requires a "training set" in the computational sense. Its performance is based on the inherent chemical and biological properties of the reagents and test strip design. Therefore, the concept of a "training set" for model development is not applicable. The studies described are analytical validation studies, not AI model training.

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

• As explained in point 8, there is no "training set" for an AI model. The ground truth for the analytical validation (which is analogous to testing the device's inherent design performance) was established by LC/MS confirmation of spiked drug concentrations in oral fluid.

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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%to cutoff) + 23 (cutoff to >+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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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.

Here's an analysis of the acceptance criteria and study details from the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the device are implicitly defined by the performance observed in the precision and method comparison studies. The document states that for precision, all test results for samples at and below -25% of the cut-off were negative, and all results for samples at and above +25% of the cut-off were positive. This indicates the device accurately identifies samples substantially below and above the cut-off.

For the method comparison, the device's performance is presented through the concordance with GC/MS results, with discordant results explicitly listed. The overall performance is demonstrated by the number of samples correctly identified as negative or positive across various concentration ranges relative to the cut-off.

Since the document does not explicitly state quantitative acceptance criteria (e.g., minimum sensitivity, specificity, or overall agreement percentage), the performance reported in the tables below represents how the device met the implied expectation of accurate qualitative detection around the cut-off.

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

The studies used unaltered clinical samples for the method comparison. The samples were collected and tested as follows for each analyte and device type (Cassette, Dipcard, Cup):

• AMP: 43 Negative urine samples, 0 samples <-50% cut-off, 12 samples -50% cut-off ~ cut-off, 23 samples cut-off ~ +50% cut-off, 17 samples >+50% cut-off. (Total = 95 samples per operator/device)
• COC: 42 Negative urine samples, 0 samples <-50% cut-off, 14 samples -50% cut-off ~ cut-off, 38 samples cut-off ~ +50% cut-off, 5 samples >+50% cut-off. (Total = 99 samples per operator/device)
• MET: 43 Negative urine samples, 0 samples <-50% cut-off, 12 samples -50% cut-off ~ cut-off, 24 samples cut-off ~ +50% cut-off, 16 samples >+50% cut-off. (Total = 95 samples per operator/device)
• OPI: 45 Negative urine samples, 0 samples <-50% cut-off, 10 samples -50% cut-off ~ cut-off, 33 samples cut-off ~ +50% cut-off, 8 samples >+50% cut-off. (Total = 96 samples per operator/device)
• PCP: 45 Negative urine samples, 2 samples <-50% cut-off, 12 samples -50% cut-off ~ cut-off, 35 samples cut-off ~ +50% cut-off, 8 samples >+50% cut-off. (Total = 102 samples per operator/device)
• THC: 44 Negative urine samples, 4 samples <-50% cut-off, 17 samples -50% cut-off ~ cut-off, 25 samples cut-off ~ +50% cut-off, 15 samples >+50% cut-off. (Total = 105 samples per operator/device)

The total number of unique samples is not directly reported, as these numbers represent the distribution of samples across different concentration ranges. Since "unaltered clinical samples" were used, this suggests they were retrospective in nature. The provenance (country of origin) of the data is not explicitly stated, but the applicant company is based in Hangzhou, China, suggesting the studies were likely performed there.

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

The ground truth for the test set was established using Gas Chromatography/Mass Spectrometry (GC/MS) and Liquid Chromatography/Mass Spectrometry (LC/MS). These are "preferred confirmatory methods" as stated in the Indications for Use. The document does not specify the number of experts or their qualifications for operating these instruments or interpreting their results; it implies the use of standard laboratory practices for these confirmatory methods.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method for the test set results. The comparison is directly between the device's qualitative result (positive/negative) and the quantitative GC/MS or LC/MS result. Discordant results are noted but no further adjudication (e.g., by multiple experts reviewing the same case) is mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study evaluated the standalone performance of the device against a gold standard (GC/MS/LC/MS), not its effectiveness in assisting human readers.

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

Yes, the studies conducted were standalone performance evaluations. The device (LYHER® Urine Multi-Drug Test Kit) is a rapid lateral flow immunoassay, which produces a visual result (line present or absent). The "operators" in the study simply interpret this visual result. The results presented are the device's performance as interpreted by an operator, not an AI algorithm. So, while it involves human interpretation of the device's output, it is a standalone performance of the device itself without additional AI assistance beyond the inherent design of the test kit.

7. The Type of Ground Truth Used

The ground truth used was quantitative analytical results from Gas Chromatography/Mass Spectrometry (GC/MS) and Liquid Chromatography/Mass Spectrometry (LC/MS). These are considered highly accurate confirmatory methods for drug detection and concentration.

8. The Sample Size for the Training Set

The document describes "Precision studies" involving spiking drugs into negative samples to achieve concentrations at various percentages around the cut-off. However, this is described as part of the analytical performance characterization and not as a "training set" for an algorithm. This device is a lateral flow immunoassay, not a machine learning or AI-based device, and therefore does not have a "training set" in the conventional sense of an AI model.

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

As this is not an AI/ML device, there isn't a "training set" that requires ground truth establishment. For the precision studies mentioned (which are part of analytical performance validation), the "ground truth" was established by spiking known concentrations of the target drug into negative urine samples. These spiked concentrations were then "confirmed by LC/MS" to ensure accuracy of the prepared samples.

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