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The LZI Cannabinoids (cTHC) 25, 50, and 100 Enzyme Immunoassays are intended for the qualitative and semi-quantitative determination of Cannabinoids in human urine using 11-nor-A -THC-9-COOH (the major metabolite of THC referred to here as cTHC) as calibrator at the cutoff values of 25, 50, or 100 ng/mL. The assays are designed for professional use with a number of automated clinical chemistry analyzers.

The semi-quantitative mode is for purposes of (1) enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as GCMS or (2) permitting laboratories to establish quality control procedures.

The LZI Cannabinoids (cTHC) Drugs of Abuse (DAU) Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of the LZI Cannabinoids (cTHC) Enzyme Immunoassay.

The LZI Cannabinoids (cTHC) Drugs of Abuse (DAU) Controls are for use as assayed quality control materials to monitor the precision of the LZI Cannabinoids (cTHC) Enzyme Immunoassay,

The assay provides only a preliminary analytical result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas or liquid chromatography|mass spectrometry (GC|MS or LC|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 test result is positive.

The LZI Cannabinoids (cTHC) 25, 50, and 100 assays are a homogeneous enzyme immunoassay with ready-to-use liquid reagent. The assays are based on competition between drug in the sample and drug labeled with the enzyme glucose-6-phosphate dehydrogenase (G6PDH) for a fixed amount of antibody in the reagent. Enzyme activity decreases upon binding to the antibody, and the drug concentration in the sample is measured in terms of enzyme activity. In the absence of drug in the sample, cannabinoid derivative -labeled G6PDH conjugate is bound to antibody, and the enzyme activity is inhibited. On the other hand, when free drug is present in the sample, antibody would bind to free drug, the unbound cannabinoid derivative - labeled G6PDH then exhibits its maximal enzyme activity. Active enzyme converts nicotinamide adenine dinucleotide (NAD) to NADH, resulting in an absorbance change that can be measured spectrophotometrically at 340 nm.

The LZI Cannabinoids (cTHC) 25, 50, and 100 Enzyme Immunoassays are kits comprised of two reagents, an R1 and R2 which are bottled separately but sold together within each kit.

The R1 solution contains a mouse monoclonal anti-cannabinoid antibody, glucose-6phosphate (G6P) nicotinamide adenine dinucleotide (NAD), stabilizers, and sodium azide (0.09%) as a preservative. The R2 solution contains glucose-6-phosphate dehydrogenase (G6PDH) labeled with a cannabinoid derivative in buffer with sodium azide (0.09%) as preservative.

The LZI Cannabinoids (cTHC) 25 Enzyme Immunoassay calibrators and controls contain 0, 12.5, 18.75, 25, 31.25, 37.5, and 50 ng/mL of 11-nor-a3-THC-9-COOH in human urine with sodium azide (0.09%) as preservative. These seven calibrators and controls are sold as individual bottles.

The LZI Cannabinoids (cTHC) 50 Enzyme Immunoassay calibrators and controls contain 0, 25, 37.5, 50, 62.5, 75, and 100 ng/mL of 11-nor-A -THC-9-COOH in human urine with sodium azide (0.09%) as preservative. These seven calibrators and controls are sold as individual bottles.

The LZI Cannabinoids (cTHC) 100 Enzyme Immunoassay calibrators and controls contain 0, 50, 75, 100, 125, 150, and 200 ng/mL of 11-nor-A -THC-9-COOH in human urine with sodium azide (0.09%) as preservative. These thirteen calibrators and controls are sold as individual bottles.

The provided text is a 510(k) summary for the LZI Cannabinoids (cTHC) Enzyme Immunoassay, and it describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and the study proving performance.

Here's a breakdown of what can be extracted and what is missing:

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

The document does not explicitly present a table of acceptance criteria or specific numerical performance metrics (like sensitivity, specificity, accuracy, or limits of detection) from a performance study. It states that the device is "identical or similar to their predicate in terms of ... clinical performance," implying that its performance is expected to meet similar standards as the previously cleared predicate device.

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 provided in the given text. A 510(k) summary often summarizes performance data but doesn't always include the granular details of study design, such as sample size of the test set or data provenance.

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 provided in the given text. For an immunoassay, the "ground truth" would typically be established by a more definitive confirmatory method (like GC/MS), not by human experts.

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

This information is not provided in the given text.

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 as the device is an in-vitro diagnostic (IVD) immunoassay, not an AI-powered diagnostic imaging device that involves human readers.

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

This is not applicable in the context of an immunoassay. The device itself is an "algorithm" (the immunoassay process) that directly produces a result. Its performance is inherent to the assay and reagents. The "human-in-the-loop" aspect for this type of device refers to the clinical interpretation of the assay result, which the document explicitly states should be followed up by a confirmatory method and professional judgment.

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

The document implicitly states the ground truth for confirming results: "A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas or liquid chromatography|mass spectrometry (GC|MS or LC|MS) is the preferred confirmatory method)." This indicates that the ground truth for performance studies would be established by these confirmatory methods.

8. The sample size for the training set

This information is not provided in the given text. For an immunoassay, the "training set" concept is less about machine learning data and more about assay development and optimization, but the specific numbers are not here.

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

This information is not provided in the given text. Similar to point 7, it would likely involve confirmatory methods during assay development.

Summary of available information:

• Device Name: LZI Cannabinoids (cTHC) Enzyme Immunoassay, Calibrators and Controls
• Intended Use: Qualitative and semi-quantitative determination of Cannabinoids in human urine at cutoff values of 25, 50, or 100 ng/mL.
• Predicate Device: Lin-Zhi International, Inc. Cannabinoid (THC) Enzyme Immunoassay, Calibrators and Controls for Hitachi 717 Systems (K021887 & K021449).
• Performance Claim: The LZI Cannabinoids (cTHC) 25, 50, and 100 Enzyme Immunoassays are "identical or similar to their predicate in terms of ... clinical performance." This is the basis for substantial equivalence.
• Ground Truth Method for Confirmation: Gas or liquid chromatography/mass spectrometry (GC/MS or LC/MS).

In conclusion, while the document confirms the device's intended use and substantial equivalence to a predicate, it lacks the specifics of detailed performance studies, sample sizes, and expert involvement that your questions are looking for. This level of detail is often found in the full 510(k) submission, not just the publicly available summary.

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