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The Triage® TOX Drug Screen is a fluorescence immunoassay intended for use in the semi-quantitative or qualitative determination of major metabolites of amphetamines, methamphetamines, barbiturates, benzodiazepines, cocaine, opiates, phencyclidine, THC, and tricyclic antidepressants in urine.

The Triage® TOX Drug Screen is a fluorescence immunoassay intended to be used with the Triage® Meter for the point-of-care semi-quantitative or qualitative determination of major metabolites of amphetamines, methamphetamines, barbiturates, benzodiazepines, cocaine, opiates, phencyclidine, THC, and tricyclic antidepressants in urine.

The Triage® TOX Drug Screen is a fluorescence immunoassay intended for use in the semi-quantitative or qualitative determination of major metabolites of amphetamines, methamphetamines, barbiturates, benzodiazepines, cocaine, opiates, phencyclidine, THC, and tricyclic antidepressants in urine.

Here's a breakdown of the acceptance criteria and study information for the Triage® TOX Drug Screen, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

The 510(k) summary does not explicitly state numerical acceptance criteria in a table format with specific pass/fail thresholds. Instead, it describes various performance studies and their general outcomes. The acceptance criteria can be inferred from the reported study objectives and conclusions.

Study Details

1. Sample Size Used for the Test Set and Data Provenance:

• Analytical Sensitivity: No specific sample size is mentioned, but "all cases" implies a comprehensive assessment across all analytes.
• Interfering Substances: No specific sample size is mentioned for the number of urine samples or interfering substances, but it states "Substances that are commonly in human urine were tested."
• Specificity/Cross-reactivity: No specific sample size is mentioned, but "Drugs and related substances were added to drug-free urine."
• Imprecision: "Three contrived specimens" were used, each evaluated multiple times to determine within-day and total imprecision.
• Threshold Challenge: No specific sample size is mentioned for the number of specimens at each concentration increment, but it states "specimens containing each drug or drug metabolite spiked into drug-free urine at concentrations in increments of 25% above and 25% below the threshold. Each specimen was tested using the Triage® TOX Drug Screen."

Data Provenance:
All studies appear to use contrived specimens (drug or related substances spiked into drug-free urine) or spiked human urine for interference testing. This suggests the data is primarily prospective and controlled, generated specifically for these studies. The country of origin is not explicitly stated, but given Biosite Incorporated is based in San Diego, CA, USA, it's highly probable the studies were conducted in the USA.

2. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

• Ground Truth Establishment: The ground truth for the test set was established through the known concentration of spiked drugs or metabolites in the urine samples. This is a common method for analytical performance testing of in vitro diagnostic devices.
• Number of Experts: No experts were directly used to "establish" the ground truth in the sense of making diagnoses or interpretations like in imaging studies. The ground truth was based on the controlled preparation of the samples.
• Qualifications of Experts: Not applicable, as expert consensus or interpretation was not the method for ground truth. However, the imprecision study notes that it was evaluated by "individuals without training as clinical laboratorians," suggesting the device is user-friendly and robust even with non-expert operators.

3. Adjudication Method for the Test Set:

• Not applicable. The studies involved analytical measurements against known concentrations or expected outcomes, not subjective interpretations requiring adjudication.

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, an MRMC comparative effectiveness study was not done. This device is an in vitro diagnostic (IVD) fluorescence immunoassay, not an AI-assisted diagnostic tool that would typically involve human readers interpreting images or data alongside an algorithm. The "readers" mentioned in the imprecision study were "individuals without training as clinical laboratorians," not expert diagnosticians whose performance would be compared or improved by an AI.

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

• Yes, a standalone study was done. The entire summary describes the performance of the Triage® TOX Drug Screen as a standalone analytical device. While it is intended for use with the "Triage® Meter," the performance data presented is for the assay system itself, without human interpretation influencing the final analytical result. The output of the device (semi-quantitative or qualitative determination) is the direct result of the immunoassay and meter.

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

• The ground truth used was spiked concentrations of drugs and drug metabolites in drug-free urine. This is a form of analytical truth or definitive truth established by controlled laboratory preparation and confirmed by reference methods (like GC/MS and HPLC, which are mentioned as predicate comparisons, implying their role in validating the concentrations).

7. The sample size for the training set:

• The 510(k) summary does not provide information on a training set sample size. This is typical for an immunoassay device. Immunoassays are based on biochemical reactions and often characterized analytically rather than "trained" in the machine learning sense. The device's performance is described through various validation studies (analytical sensitivity, interference, specificity, imprecision, threshold challenge) using the described test sets, not a separate training set.

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

• Not applicable. As a traditional immunoassay, there isn't a "training set" in the context of machine learning, so the method for establishing ground truth for a training set is not relevant. The device operates based on predefined antibody-antigen reactions and calibration, not machine learning from a training dataset.

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