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The Pan Probe Biotech (PPB), Inc LiveSure™ Methadone Screen Test Card & Test Strip devices are rapid in vitro diagnostic (IVD) qualitative lateral flow competitive immuno-chromatographic urinary screening devices intended for detection of Methadone, its analogs and metabolites (collectively termed: screening at the NIDA (National Institute on Drug Abuse) and SAMHSA (Substance Abuse and Health Services Administration) cut-off level of 300 ng MED/ml of human urine. These PPB Mcharl Featur bervices Hand & Test Strip IVD immunoassay devices are designed for visual, qualitative screening, for professional use only, and are not intended for quantitative results, nor for quanuative berealling) for presentativeSure™ Methadone Test Card & Test Strip devices provide only ovel ate commal (or o) creening data for use to aid in the diagnosis of drug abuse or over use. A premium y quantitative alternative method must be used in order to obtain a confirmed analytical result. NIDA and SAMHSA have established gas chromatographic/mass spectrometry (GC/MS) as the result. NDTT and of micel considerations and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.

The Pan Probe Biotech LiveSure™ Methadone Screen Test Card and Test Strip (i.e., LiveSure™ Methadone) which are rapid qualitative chromatographic IVD immunoassays, in which chemically labeled drug conjugate competes with any Methadone (MED) drugs, analogs or metabolites that may be in the conjugure comples for limited specific antibody binding sites. LiveSure™ Methadone devices prescient in test annual bas been pre-coated both with a Methadone (MED-)drug conjugate at the test band, and is followed by a built-in reference band with a second antibody as a system control band. A test colored anti-MED monoclonal antibody-colloidal gold conjugate pad is placed to the right of a test strip. In the absence of MED drugs, analogs or metabolites in urine, pink colored antibody-colloidal gold conjugates move chromatographically along with the urinary samples on the membrane by capillary ection. Antibody-colloidal gold conjugate binds to MED-drug conjugate, forming an antibody-antigen complex. This antibody-MED-drug conjugate appears as second visible pink colored band and captured reagent at the test region. Any MED present in a sample urine act as antigens, competing with MED-drug reagon at the test band region for limited MED-antibody binding sites on antibody-colloidal gold conjugate. When a sufficient concentration of urinary MED drugs, analogs or metabolites are present, these analytes block the limited antibody binding sites. This blockage-binding process prevents attachment of anial colored antibody-colloidal gold conjugate at the MED-drug conjugate zone located at the test band region. To serve as a procedural control, a pink colored band in a control region will always appear, regardless of the presence of MED in urine samples. Thus, negative urine samples produce two pink colored bands, while positive urine samples produce only one pink colored band.

Here's an analysis of the provided text regarding the Pan Probe Biotech LiveSure™ Methadone Screen Test Card & Test Strip, structured according to your request:

Acceptance Criteria and Device Performance Study

The information provided describes the performance of the Pan Probe Biotech LiveSure™ Methadone Screen Test Card & Test Strip against a predicate device (EMIT® II) and a gold standard (GC/MS).

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the comparison to the predicate device and the GC/MS gold standard. The document doesn't explicitly state quantitative acceptance criteria in a formal "pass/fail" sense prior to presenting results, but rather demonstrates "substantial equivalence." However, we can infer the desired equivalency based on the reported performance.

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

• Sample Size for Test Set: 301 urine samples.
• Data Provenance: Independent clinical testing at an external reference laboratory. The country of origin is not explicitly stated, but the overall context of an FDA 510(k) submission for a US market suggests it was likely US-based or conducted under US regulatory standards. The study was prospective in the sense that the samples were tested against the new device (LiveSure™ Methadone), the predicate device (EMIT® II), and the confirmatory method (GC/MS) in the context of this evaluation.

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

The ground truth was established by Gas Chromatography/Mass Spectrometry (GC/MS). Therefore, the "experts" in this context are the trained laboratory personnel who perform and interpret GC/MS results. The number of such personnel is not specified, nor are their individual qualifications beyond the implication that they operate an "external reference laboratory" providing professional GC/MS quantitative results. GC/MS is considered the definitive method for drug confirmation.

4. Adjudication Method for the Test Set

There was no explicit "adjudication method" in the typical sense (e.g., 2+1 expert review). The GC/MS results served as the definitive quantitative ground truth against which all other results (LiveSure™ Methadone and EMIT® II) were compared. Any discrepancies between the rapid tests and GC/MS would be resolved by the GC/MS result being the accepted truth.

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 LiveSure™ Methadone device is a "rapid qualitative chromatographic IVD immunoassay" designed for visual interpretation. While technicians would read the results, the study focuses on the device's accuracy against a gold standard, not on the variability or improvement in human reader performance with or without AI assistance. The device itself is not described as having an AI component to assist human readers.

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

Yes, the study primarily presents standalone performance of the device. The LiveSure™ Methadone device itself (the test card/strip) is tested as an algorithm for detecting methadone. Its "algorithm" is the biochemical reaction and visual readout. There is no complex digital algorithm or "human-in-the-loop" described beyond a technician visually interpreting the bands. The performance metrics (sensitivity, specificity, accuracy) are for the device's inherent ability to produce a correct result.

7. The Type of Ground Truth Used

The primary and definitive ground truth used was GC/MS (Gas Chromatography/Mass Spectrometry) quantitative results. This is considered the "gold standard" for drug testing, providing objective, confirmatory, and quantitative data.

8. The Sample Size for the Training Set

The document does not explicitly state a training set sample size. The text describes "In-house testing" preceding the independent clinical testing, but it doesn't quantify this in-house testing as a separate "training set" in the machine learning sense. The device is a chemical immunoassay, not a machine learning algorithm that typically requires a large, separate training dataset. The development and internal validation of such a device involve optimization and testing, but these are generally considered part of the design process rather than a discrete "training set" for statistical model fitting.

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

Since a distinct "training set" is not detailed or quantified in the provided text as it would be for AI/ML, the method for establishing its ground truth is also not explicitly stated. However, given the nature of the device and the later clinical study, it's highly probable that "in-house testing" and development would have also relied on GC/MS or similar confirmatory methods to validate prototype performance and optimize the assay parameters (e.g., antibody concentrations, cutoff levels) against known positive and negative samples. The document states "under Good Laboratory Practices guidelines," implying rigorous internal validation processes.

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