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The ACON OXY II One Step Oxycodone Test Strip and the ACON OXY II One Step Oxycodone Test Device are rapid chromatographic immunoassays for the qualitative detection of Oxycodone levels in urine at a designated cutoff concentration of 100 ng/mL. They are intended for healthcare professionals including professionals at point-of-care sites.

This assay provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) are the preferred confirmatory methods.

Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

The ACON OXY II One Step Oxycodone Test Strip and the ACON OXY II One Step Oxycodone Test Device are competitive binding, lateral flow immunochromatographic assays for the qualitative screening of Oxycodone in a urine sample. The test is based on the principle of antibody immunochemistry. It utilizes the mouse monoclonal antibody to selectively detect elevated levels of Oxycodone and its metabolite in urine at a cutoff concentration of 100 ng/mL. These tests can be performed without the use of an instrument.

A drug-positive urine specimen will not generate a colored-line in the designated test region. while a negative urine specimen or a urine specimen containing Oxycodone at the concentration below the cutoff level will generate a colored-line in the test region. To serve as a procedural control, a coloredline should always appear at the control region, indicating that proper volume of specimen has been added and membrane wicking has occurred.

Here's an analysis of the provided text regarding the ACON® OXY II One Step Oxycodone Test Strip and Test Device, structured to address your specific questions about acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined "acceptance criteria" in terms of specific thresholds for positive, negative, or overall agreement. Instead, it presents the results of a comparison study against a predicate device and GC/MS, implying that the observed performance was deemed acceptable for substantial equivalence.

We can infer the reported device performance from the provided data:

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

• Sample Size for Test Set: 300 clinical urine specimens.
• Data Provenance: The document states "clinical urine specimens," implying these were collected from human subjects. There is no specific mention of the country of origin. The study is retrospective as it compares the device's results with data obtained from other tests (predicate device and GC/MS) on pre-existing samples. Approximately 10% of the specimens had Oxycodone concentrations between -25% and +25% of the cutoff (100 ng/mL).

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

• Number of Experts: Not explicitly stated. The "ground truth" reference method for a significant portion of the test set was Gas Chromatography/Mass Spectrometry (GC/MS) analysis. GC/MS is an objective analytical method and therefore doesn't typically involve human "experts" establishing the ground truth in the same way, for example, a radiologist would interpret an image.
• Qualifications of Experts: Not applicable for GC/MS analysis. For the comparison against a "FDA-cleared Oxycodone test," no information is provided regarding the interpretation of that predicate device's results by human experts.

4. Adjudication Method for the Test Set

• Adjudication Method: Not explicitly described. For the GC/MS comparison, the results of the GC/MS are the reference standard. The document mentions "Negative specimens were confirmed using GC/MS analysis by pooling these samples in groups of 5," which is a method for efficiency in confirmatory testing rather than an adjudication process between conflicting interpretations. For the comparison against the predicate device, it seems a direct comparison of the readings was performed without an explicit adjudication process for discordant results.

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

• MRMC Study: No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study focuses on the analytical performance of a rapid diagnostic test, not on human reader performance with or without AI assistance.
• Effect Size of Human Readers with/without AI: Not applicable, as this was not an AI-assisted diagnostic study. However, a "POL Study Summary" did assess the ability of personnel at different doctor's offices to correctly perform and interpret the test, indicating a high level of agreement (97%, 262/270 for non-lab personnel vs. 97%, 87/90 for a trained lab technician). This is a user-performance study, not an MRMC study comparing AI-assisted vs. unassisted human performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• This device is a rapid chromatographic immunoassay, which is a standalone device in the sense that its output (a colored line or absence thereof) is the direct result. It does not involve a complex algorithm or AI where "human-in-the-loop" would be a distinct mode of operation. The user visually interprets the result (positive or negative).

7. The Type of Ground Truth Used

• Type of Ground Truth: The primary and most robust ground truth used was Gas Chromatography/Mass Spectrometry (GC/MS) analysis. This is an analytical chemistry method considered the gold standard for confirming drug presence and concentration. Additionally, the results were compared against an existing "FDA-cleared Oxycodone test," which serves as a secondary reference.

8. The Sample Size for the Training Set

• Sample Size for Training Set: The document does not provide information regarding a separate "training set" for the device. Rapid diagnostic tests like this immunoassay are typically developed and optimized through laboratory analytical studies (sensitivity, specificity, cross-reactivity, etc.) and then validated using clinical samples, rather than being "trained" on a dataset in the way a machine learning algorithm would be. The clinical evaluation described used 300 clinical urine specimens for its performance assessment.

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

• Ground Truth for Training Set: As no "training set" is explicitly mentioned for a machine learning context, this question is not applicable in the conventional sense. The device's inherent analytical characteristics (antibody specificity, cutoff sensitivity) are established through analytical studies as mentioned under "Performance Characteristics and Other information" (analytical sensitivity, specificity, cross-reactivity, interference, precision studies). The "ground truth" for those analytical studies would be precisely prepared control samples with known concentrations of oxycodone and other substances.

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