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The Emit® II Plus Amphetamines Assay is a homogeneous enzyme immunoassay with a 300 ng/mL cutoff, 500 ng/mL cutoff or a 1000 ng/mL cutoff (SAMHSA initial test cutoff level). The assay is intended for use in the qualitative and semiquantitative analyses of amphetamines in human urine. Emit® II Plus assays are designed for use with a number of chemistry analyzers.

The Emit® II Plus Amphetamines Assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug-of-abuse test result, particularly when preliminary positive results are used.

The Emit® II Plus Amphetamines Assay is a homogeneous enzyme immunoassay for the qualitative and semiquantitative analysis of amphetamines in human urine.

Here's an analysis of the provided text regarding the Syva® Emit® II Plus Amphetamines Assay, broken down by your requested criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the reported "Percent agreement" with the reference method (GC/MS). While a specific pre-determined threshold for acceptance isn't explicitly stated as "acceptance criteria," the goal is to show a high agreement.

Note: For the 1000 ng/mL cutoff, there are two comparisons: one against GC/MS and one against the predicate device (Syva® Emit® II Plus Monoclonal Amphetamine/Methamphetamine Assay). Both are listed in the table.

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

• Sample Size for Test Set: 124 urine specimens were used for method comparison studies for each cutoff level (300 ng/mL, 500 ng/mL, and 1000 ng/mL).
• Data Provenance: The document does not specify the country of origin of the data. It also does not explicitly state whether the study was retrospective or prospective. Given that specimens were "obtained" and then analyzed by both the proposed device and GC/MS, it is likely a retrospective analysis of collected urine samples.

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

This information is not provided in the document. The ground truth was established by Gas Chromatography/Mass Spectrometry (GC/MS) which is a laboratory analytical method, not typically performed by "experts" in the clinical sense (e.g., radiologists). The document does not describe who performed the GC/MS analysis or their qualifications.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided. Adjudication typically refers to resolving discrepancies between multiple human readers or between a human reader and an AI. In this study, the primary ground truth is established by an objective analytical method (GC/MS), and the device's results are compared directly to that. There is no mention of human readers or a need for adjudication among them. Discrepancies between the device and GC/MS are reported and sometimes further analyzed semiquantitatively.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. This device is an in vitro diagnostic (IVD) assay designed to provide a chemical analysis of urine, not to assist human readers in interpreting images or clinical data. Therefore, there's no "human readers improve with AI vs without AI assistance" aspect to evaluate.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)

Yes, a standalone performance study was done. The Syva® Emit® II Plus Amphetamines Assay is an automated enzyme immunoassay performed on a chemistry analyzer (Syva®-30R Biochemical System). The results presented are the direct output of this automated system compared to the reference method (GC/MS), without any human interpretation of the assay results before comparison. It functions as an "algorithm only" in the context of an IVD.

7. Type of Ground Truth Used

The type of ground truth used was Gas Chromatography/Mass Spectrometry (GC/MS) results. This is considered a highly specific and sensitive reference method for confirming the presence and concentration of substances in biological samples, making it an objective and reliable ground truth for in vitro diagnostic assays like this.

8. Sample Size for the Training Set

The document does not specify a discrete "training set" sample size. For an IVD assay, the development process involves optimization and calibration, which would use various samples, but this is not typically reported as a "training set" in the same way machine learning models report it. The reported studies are for performance validation rather than model training.

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

Since a distinct "training set" with established ground truth as per common AI/ML terminology is not explicitly mentioned or described for this IVD, this information is not provided. The development of the assay itself would involve internal studies and verification cycles, likely using methods such as GC/MS to establish the reference values for calibrators and controls used in the assay.

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When a sample is mixed with the reagent containing the detergent and the vanadate, at around pH 3, total bilirubin in the sample is oxidized to biliverdin. This causes the absorbance of yellow, specific to bilirubin, to decrease. Therefore, the total bilirubin concentration in the sample can be obtained by measuring the absorbance before and after the vanadate oxidation.

Here's a breakdown of the acceptance criteria and the study details for the Wako Total Bilirubin V assay, based on the provided text:

Acceptance Criteria and Reported Device Performance

Study Details

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

   • The document states that "serum samples" were used for comparison studies against the predicate assay. The exact number of samples is not specified.
   • The data provenance (country of origin, retrospective or prospective) is not specified.

2. 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 study compares a new device to a predicate device, not against a clinical expert's interpretation. The "ground truth" for the test set is established by the results from the predicate device (Wako's previous Total Bilirubin assay, K912024/A).

3. Adjudication method for the test set:

   • Not applicable. This is a comparison of quantitative measurements between two devices, not a qualitative assessment requiring adjudication of human interpretations.

4. 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. This is a study comparing two laboratory diagnostic devices for bilirubin measurement, not a study involving human readers or AI assistance.

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

   • Yes. This study describes the performance of a standalone laboratory assay (Wako Total Bilirubin V) in comparison to another standalone laboratory assay (the predicate device). There is no "human-in-the-loop" component in the direct measurement process being evaluated.

6. The type of ground truth used:

   • The "ground truth" for the comparative study was the results obtained from the predicate device (Wako's previous Total Bilirubin assay, 510(k)#K912024/A).

7. The sample size for the training set:

   • This concept is not applicable to this type of device and study. The Wako Total Bilirubin V assay is a chemical measurement method; it does not involve machine learning algorithms that require a "training set."

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

   • Not applicable, as there is no training set for this device.

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