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BIOEASY Multi-Drug Test Cup Tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, Nortriptyline and d-Propoxyphene in human urine at the cutoff concentrations of:

Configuration of the BIOEASY Multi-Drug Test Cup tests can consist of any combination of the above listed drug analytes.

The test may yield positive results for the prescription drugs Buprenorphine, Nortriptyline, 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 BIOEASY Multi-Drug Test 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, Methylenedioxymethamphetamine, Phencyclidine, Methadone, Nortriptyline and Propoxyphene (target analytes) in human urine. The products are single-use in vitro diagnostic devices. Each test kit contains a Test Device, 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 performance of the BIOEASY Multi-Drug Test Cup, an in-vitro diagnostic device for qualitative and simultaneous detection of various drugs in human urine. Here's a breakdown of the acceptance criteria and study details:

1. A table of acceptance criteria and the reported device performance

The document doesn't explicitly state "acceptance criteria" in a separate table. However, the performance is demonstrated through precision studies and lay-user studies, showing the device's ability to correctly identify drug presence/absence at specific concentrations relative to the defined cutoff levels. The implicit acceptance criteria appear to be high percentages of correct results, particularly at and beyond the +/- 25% cutoff concentrations. For the lay user study, 90-100% correct results were generally achieved across different drug panels and concentrations close to the cutoff, with 100% correct results for samples far from the cutoff.

Here's an aggregated summary of the performance for each drug panel from the lay user study, which serves as a key indicator of device performance in the hands of intended users:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Precision Studies: For each drug concentration point tested (-100% cut off, -75% cut off, -50% cut off, -25% cut off, +25% cut off, +50% cut off, +75% cut off, and +100% cut off), tests were performed for 25 days per device, with two runs per day for each drug. This means 50 runs per concentration for each drug across three lots (total of 150 runs per concentration per drug across lots). The samples were prepared in-house by spiking drugs into negative samples. The data provenance is implied to be from the manufacturer's lab, likely Shenzhen, China, where the submitter is located. This appears to be a prospective internal study.
• Method Comparison Studies: 80 (40 negative and 40 positive) unaltered clinical samples for each drug were used. The samples were blind labeled. These appear to be retrospective clinical samples, but the country of origin is not specified.
• Lay-user Study: 300 lay persons participated. Urine samples were prepared at varying concentrations: negative, +/-75%, +/-50%, +/-25% of the cutoff. Each participant received one blind-labeled sample and one device. The number of samples tested at each concentration varied per drug, as shown in the tables (e.g., 20 samples for -100% cutoff, 160 for -50% cutoff, 40 for +50% cutoff). These were likely prepared in-house or externally for the study, making it a prospective study, though the country of origin for the lay users is not specified (but likely related to the submitter's regions of operation or intended market).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Precision and Lay-user Studies: The "ground truth" for the urine samples in these studies was established by LC/MS (Liquid Chromatography/Mass Spectrometry) or LC/MS/MS, which is a gold standard analytical method for drug concentration determination. The number or qualifications of the individuals performing the LC/MS analysis are not specified, but it's presumed to be trained laboratory personnel.
• Method Comparison Studies: The ground truth for the 80 clinical samples was also established by LC/MS. The number or qualifications of the individuals performing the LC/MS analysis are not specified.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Precision Studies: The document doesn't explicitly state an adjudication method. "All sample aliquots were blindly labeled by the person who prepared the samples and didn't take part in the sample testing." The results presented are counts of "positive" and "negative" outcomes.
• Method Comparison Studies: The studies were performed in-house with three laboratory assistants for each device. The results are summarized by "Viewer A," "Viewer B," and "Viewer C." This indicates a multi-reader approach. However, there's no mention of an adjudication process (e.g., 2+1, 3+1) if their readings disagreed. The discordant results table lists individual discrepancies.
• Lay-user Study: Each participant tested one device and recorded their results. The assessment of whether their result was "correct" was based on the LC/MS confirmed concentration of the sample they received. No adjudication among lay users is mentioned or appropriate for this type of study.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study focusing on human readers improving with AI vs. without AI assistance was not done. This device is a lateral flow immunoassay, a point-of-care test that human users (including lay users) interpret visually. It is not an AI-assisted diagnostic device.

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

No, a standalone algorithm-only performance study was not done, as this device does not incorporate an AI algorithm. Its performance is based on the chemical reaction and visual interpretation.

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

The ground truth used for validating the device's performance was primarily analytical confirmation by LC/MS or LC/MS/MS. This is considered a highly accurate and quantitative laboratory diagnostic method for determining drug concentrations.

8. The sample size for the training set

The document does not describe a "training set" in the context of an AI/ML algorithm. This device is a lateral flow immunoassay and does not employ machine learning or AI that would require a separate training dataset. The studies described are for analytical and clinical validation of the immunoassay.

9. How the ground truth for the training set was established

As there is no AI/ML component mentioned and thus no "training set," this question is not applicable to the information provided.

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BIOEASY Multi-Drug Test Cup Tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, Nortriptyline and d-Propoxyphene in human urine at the cutoff concentrations of:

Configuration of the BIOEASY Multi-Drug Test Cup tests can consist of any combination of the above listed drug analytes.

The test may yield positive results for the prescription drugs Buprenorphine, Nortriptyline, 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 BIOEASY Multi-Drug Test 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, Methylenedioxymethamphetamine, Phencyclidine, Methadone, Nortriptyline and Propoxyphene (target analytes) in human urine. The products are single-use in vitro diagnostic devices. Each test kit contains a Test Device, a package insert and a urine cup for sample collection. Each test device is sealed with a desiccant in an aluminum pouch

Here's an analysis of the acceptance criteria and the study that proves the device meets the acceptance criteria, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the successful outcomes of the various performance studies. The reported device performance is excellent, demonstrating near-perfect agreement with the LC/MS ground truth for samples outside the +/-25% cutoff range, and reasonable agreement within the +/-25% cutoff range, which is expected for qualitative tests around the cutoff.

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

• Precision Studies:

  • For each of the 14 analytes, 8 concentrations were tested (ranging from -100% cut off to +100% cut off).
  • For each concentration, tests were performed two runs per day for 25 days, using 3 different lots of the device.
  • Total samples per lot per concentration: 50 (2 runs/day * 25 days).
  • Total samples per drug per concentration for 3 lots: 150 (50 * 3 lots).
  • Total samples per drug: 1,200 (150 * 8 concentrations).
  • Total samples for all 14 drugs in precision study: 16,800.
  • Data Provenance: The text does not explicitly state the country of origin but implies it was performed "in-house" by the manufacturer (Shenzhen Bioeasy Biotechnology Co., Ltd. in China). These samples were prepared by spiking drug in negative samples. The study appears to be prospective in nature for the purpose of device validation.

• Interference & Specificity Studies:

  • "Three batches of each device" were used.
  • The number of individual samples tested for each interfering substance or cross-reactant is not explicitly stated, but it involved "drug-free urine and target drugs urine with concentrations at 25% below and 25% above Cut-Off levels."

• Effect of Urine Specific Gravity and pH:

  • "Three lots of each device" were used.
  • "Urine samples, with 1.000 to 1.035 specific gravity or urine samples with pH 4 to 9 were spiked with target drugs at 25% below and 25% above Cut-Off levels." The exact number of samples at each specific gravity/pH level is not detailed.

• Method Comparison (Professional User) Studies:

  • For each of the 14 analytes: 80 unaltered clinical samples (40 negative and 40 positive).
  • Total samples for 14 drugs: 1120 samples.
  • Data Provenance: "clinical samples" are mentioned, but their country of origin is not specified. The study is retrospective, as these are "unaltered clinical samples" compared to LC/MS results.

• Lay-user Study:

  • 300 lay persons were involved.
  • The text describes sample numbers for various concentrations. For each drug, a total of 300 samples were prepared the following way: 20 at -100% Cutoff, 20 at -75%, 160 at -50%, 20 at -25%, 20 at +25%, 40 at +50%, 20 at +75%.
  • Total samples per drug: 300.
  • Total samples for all 14 drugs in lay-user study: 4,200.
  • Data Provenance: The text does not explicitly state the country of origin for the urine samples, but the study was conducted at "three intended user sites." These samples were prepared by spiking drugs into drug-free pooled urine specimens. The study itself is prospective in terms of collecting performance data from lay users.

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

• Method Comparison Studies: The ground truth was established by LC/MS (Liquid Chromatography-Mass Spectrometry). This is a highly accurate analytical method, considered the gold standard for drug confirmation in urine. No human experts are explicitly mentioned for establishing the ground truth in these studies, as the LC/MS directly provides it. The "three laboratory assistants" who ran the devices are operators, not ground truth experts.

• Precision, Interference, Specificity, Effect of Urine Specific Gravity and pH, Lay-user Studies: The ground truth for these studies was established by LC/MS to confirm the drug concentrations in the spiked urine samples.

4. Adjudication Method for the Test Set

• Precision Studies: Not explicitly stated, however, the results were quantified as positive/negative based on the criteria for each concentration and then tabulated. No formal adjudication process among multiple readers is described for the precision data, as the device's output (presence/absence of line) is objectively recorded.

• Method Comparison Studies: Three "laboratory assistants" viewed the device results, and their readings were compared against the LC/MS ground truth. There is no mention of an adjudication process (e.g., 2+1, 3+1) among these three assistants. Each viewer's discordant results were individually reported.

• Lay-user Study: The results from each lay person were recorded (positive/negative) and then compared to the known LC/MS-confirmed concentration of the sample. No adjudication among lay users is mentioned.

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

• No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. This device is a rapid, qualitative drug test cup, which provides a direct visual result (lines appearing/not appearing). It does not involve AI assistance, nor does it involve human readers interpreting complex images or data that AI would augment. Therefore, there's no discussion of human readers improving with AI assistance.

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

• Yes, in the context of the device's output. The "Precision" studies and the "Interference," "Specificity," and "Effect of Urine Specific Gravity and pH" studies represent the standalone performance of the device itself to detect the analytes, as the results are based on the chemical reactions within the cup. The "Method Comparison" study also evaluates the standalone performance of the device's reading mechanism when interpreted by professional users, directly comparing it to the LC/MS reference.

7. The Type of Ground Truth Used

• The primary ground truth used across all analytical and clinical (in-house) studies was LC/MS (Liquid Chromatography-Mass Spectrometry). For the precision, interference, specificity, and pH/SG studies, the samples were spiked with known concentrations confirmed by LC/MS. For the method comparison study, unaltered clinical samples were directly compared against LC/MS results.

8. The Sample Size for the Training Set

• This device is a lateral flow immunochromatographic assay, not an AI/machine learning model. Therefore, there is no concept of a "training set" in the traditional sense for an algorithm. The development and optimization of the test's chemical components and cutoff concentrations implicitly involve internal R&D and calibration, but this is distinct from training an AI model on a dataset.

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

• As stated above, this is not applicable as it's not an AI/machine learning device requiring a training set. The "ground truth" for establishing the device's analytical performance (e.g., cutoff levels, cross-reactivity) would have been determined through empirical testing and comparison against established analytical methods like LC/MS during the device's development and validation.

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