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AssureTech Panel Dip Tests and AssureTech Quick Cup Tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cocaine, Marijuana Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamine, Phencyclidine. Methadone, EDDP, Nortriptyline and d-Propoxyphene in human urine at the cutoff concentrations of:

Configuration of the AssureTech Panel Dip Tests and the AssureTech Quick Cup Tests can consist of any combination of the above listed drug analytes.

The test may yield positive results for the prescription drugs Buprenorphine, Oxazepam, Secobarbital, Propoxyphene and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method.

For in vitro diagnostic use only.

The AssureTech Panel Dip Tests and AssureTech Quick Cup Tests are immunochromatographic assays that use a lateral flow system for the qualitative detection of Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, EDDP, Nortriptyline and Propoxyphene (target analytes) in human urine. The products are single-use in vitro diagnostic devices, which come in the formats of Panel Dip Cards or Cups. Each test kit contains a Test Device (in one of the two formats), a package insert and a urine cup for sample collection. Each test device is sealed with a desiccant in an aluminum pouch

The provided document describes the validation of the AssureTech Panel Dip Tests and AssureTech Quick Cup Tests for qualitative and simultaneous detection of various drugs in human urine. The study presented focuses on the analytical performance, comparison with a predicate device, and a lay-user study.

Here's an analysis of the acceptance criteria and study proving the device meets them:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as numerical targets in a dedicated table, but are implied by the results of the precision studies and lay-user studies demonstrating high percentages of correct results around the cutoff concentrations. For the lay-user study, the implicitly accepted performance is 90-100% correct results across various drug concentrations, particularly at and near the cutoff levels.

Here's a table summarizing the reported device performance, based on the lay-user study, for each tested drug, focusing on the "The percentage of correct results (%)" column. Note that the precision studies showed similar performance for different lots and concentration ranges.

Table of Acceptance Criteria (Implied) and Reported Device Performance (Lay-User Study)

Note on Buprenorphine (BUP) results: The table for BUP in the document has missing values ("С Г لك ه" and blank for "No. of Negative"). This prevents reporting the exact percentages for those concentrations. However, the existing data for BUP still shows high performance where reported.

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

• Lay-user Study (Primary Test Set):

  • Sample Size: 310 lay persons for each device format (Panel Dip Tests and Quick Cup Tests). For each drug, there were varying numbers of samples at different concentrations: 20 samples at -100%, -75%, -25%, +25%, +75% cutoff, and 170 samples at -50% cutoff, and 40 samples at +50% cutoff.
  • Data Provenance: The origin of the urine samples (e.g., country of origin) is not specified. The study was conducted "in-house" (meaning by the manufacturer or their designated testing facility) and appears to be prospective in nature, as samples were prepared by spiking drugs into negative urine specimens, aliquoted, and then distributed blindly to users.

• Comparison Studies (Clinical Samples):

  • Sample Size: For each drug, 80 unaltered clinical samples (40 negative and 40 positive). These were tested by three laboratory assistants for each device.
  • Data Provenance: The origin (e.g., country) of these clinical samples is not specified. They are described as "clinical samples," implying they were collected from real patients, making this a retrospective evaluation of existing samples.

• Precision Studies:

  • Sample Size: For each drug concentration (-100% cut off, -75% cut off, -50% cut off, -25% cut off, cut off, +25% cut off, +50% cut off, +75% cut off, +100% cut off), tests were performed in two runs per day for 25 days, for a total of 50 tests per concentration per lot. With 3 lots tested, this amounts to 150 tests per concentration.
  • Data Provenance: Samples were "prepared by spiking drug in negative samples," indicating these were lab-prepared samples, making it a prospective controlled study.

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

• Lay-user Study Ground Truth: The ground truth for the lay-user study samples was established by LC/MS (Liquid Chromatography-Mass Spectrometry), which is a gold standard analytical method for drug concentration determination. The document states: "The concentrations of the samples were confirmed by LC/MS." No human experts are explicitly mentioned as establishing the ground truth for this set beyond the technical personnel operating the LC/MS.

• Comparison Studies Ground Truth: The ground truth for the clinical samples in the comparison studies was also established by LC/MS. The document states: "The samples were blind labeled and compared to LC/MS results." Similarly, no human expert consensus or interpretation was required for establishing the ground truth for these samples, as LC/MS provides a quantitative, objective measure.

• Precision Studies Ground Truth: The ground truth for these spiked samples was also established by LC/MS to confirm the prepared drug concentrations.

4. Adjudication Method for the Test Set

• Lay-user Study: No adjudication method is described. Each lay participant evaluated their assigned blind-labeled sample independently. The results were then compared to the LC/MS ground truth.

• Comparison Studies: No adjudication method is described. Three laboratory assistants independently ran the samples, and their results were compared directly to the LC/MS results. Discordant results are individually listed but no process for reconciling them or for a consensus reading is mentioned using these three viewers.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size.

• No MRMC study involving human readers improving with AI vs. without AI assistance was done. This device is a rapid, lateral flow immunochromatographic assay, not an AI-assisted diagnostic tool requiring human interpretation with or without AI. The "readers" in the comparison study are laboratory assistants interpreting the dip/cup test results, not radiologists or similar specialists interpreting complex images, and no AI component is involved for assistance.

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

• Not applicable. The device itself is the "algorithm" in a sense, as it performs the chemical reaction to yield a positive or negative result. The studies assess the performance of this device. There is no separate, purely computational algorithm. The device's performance is inherently "standalone" in how it chemically processes the sample and displays a result, which is then visually interpreted by a human user (whether a lab assistant or a layperson).

7. The Type of Ground Truth Used

• The primary type of ground truth used for both the precision studies, comparison studies, and the lay-user study was analytical confirmation by LC/MS (Liquid Chromatography-Mass Spectrometry). This is a highly accurate and objective method for determining the concentration of drugs in a sample, which then defines whether a sample is truly positive or negative relative to a specific cutoff.

8. The Sample Size for the Training Set

• Not applicable / Not explicitly stated. This is a chemical assay, not a machine learning model, so there isn't a "training set" in the conventional AI/ML sense. The device's components and parameters are developed through R&D, not through training on a dataset. The results presented are for validation and performance evaluation.

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

• Not applicable. As there is no "training set" for an AI/ML model for this type of device, the concept of establishing ground truth for a training set doesn't apply. The device's underlying chemistry and immunoassay principles are based on established scientific knowledge.

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