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The AssureTech Quick Cup Tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Secobarbital, Buprenorphine, Oxazepam, Cocaine, EDDP, Fentanyl, Ecstasy, Propoxyphene, Morphine, Methadone, Phencyclidine, Oxycodone, Norfentanyl, Methamphetamine, Nortriptyline, 6-Monoacetylmorphine, Tramadol and Marijuana in human urine at the cutoff concentrations of:

Configuration of 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 above 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 method 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 Multi-drug Urine Test Cup are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Secobarbital, Buprenorphine, Oxazepam, Cocaine, EDDP, Fentanyl, Ecstasy, Propoxyphene, Morphine, Methadone, Phencyclidine, Oxycodone, Norfentanyl, Methamphetamine, Nortriptyline, 6-Monoacetylmorphine, Tramadol and Marijuana in human urine at the cutoff concentrations of:

Configuration of the AssureTech Multi-drug Urine Test Cup can consist of any combination of the above listed drug analytes. It is for in vitro diagnostic use only.

The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

The AssureTech Quick Cup Tests are immunochromatographic assays that use a lateral flow system for the qualitative detection of Amphetamine, Secobarbital, Buprenorphine, Oxazepam, Cocaine, EDDP, Fentanyl, Ecstasy, Propoxyphene, Morphine, Methadone, Phencyclidine, Oxycodone, Norfentanyl, Methamphetamine, Nortriptyline, 6-Monoacetylmorphine, Tramadol and Marijuana (target analytes) in human urine. The products are single-use in vitro diagnostic devices. Each test kit contains a Test Device and a package insert. Each test device is sealed with a desiccant in an aluminum pouch.

The provided FDA 510(k) Clearance Letter details the performance of the AssureTech Quick Cup Tests and AssureTech Multi-drug Urine Test Cup for qualitative and simultaneous detection of various drugs in human urine.

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

1. Acceptance Criteria and Reported Device Performance

For in vitro diagnostic devices like these, acceptance criteria are typically related to the accuracy of the qualitative detection (positive vs. negative) compared to a gold standard, particularly around the established cutoff concentrations. The performance is assessed through analytical studies (precision, specificity, interference) and comparison studies with a confirmatory method.

Here's a table summarizing the implicit acceptance criteria based on the precision and lay-user studies, and the reported device performance. The acceptance criterion is inferred as the ideal performance for these types of tests, where results near or above the cutoff should be positive, and results significantly below should be negative. The performance data below is extracted from the "Precision" and "Lay-user study" sections.

Table of Acceptance Criteria and Reported Device Performance

Note: The precision study for AMP300, MET300, and TML100 used 3 lots, with "50-/0+" meaning 50 negative results and 0 positive results, and "50+/0-" meaning 50 positive results and 0 negative results. For the 'Cutoff' concentration, it shows a mix of positive and negative results, which is expected due to the nature of qualitative assays around the threshold.

2. Sample Sizes and Data Provenance

• Precision Study:

  • For AMP300, MET300, and TML100: Each drug had 8 concentrations (spanning -100% to +100% of cutoff, plus the cutoff). For each concentration, tests were performed two runs per day for 25 days, for 3 different lots.
    • This means 50 observations per concentration per lot (2 runs/day * 25 days/run).
    • Total observations per drug for all 3 lots: 8 concentrations * 50 observations/concentration * 3 lots = 1200 observations per drug.
  • Data for other drugs refer to previous 510(k) clearances (K243996, K201630, K181768, K180349, K170049, K161044, K153465, K152025, K151211).
  • Data Provenance: Retrospective, as samples were "prepared by spiking drug in negative samples" and confirmed by LC/MS. No specific country of origin is mentioned, but typically for FDA submissions, studies are conducted under GLP (Good Laboratory Practice) guidelines, often in the US or by international labs adhering to comparable standards.

• Comparison Studies (Clinical Samples):

  • For AMP300, MET300, and TML100: The tables show data broken down by "Negative" (presumably drug-free), "Low Negative" ( +50%). The sum of the positive and negative results across these categories for each operator represents the number of clinical samples tested for that drug.
    • AMP300: 5 (Negative) + 15 (LN) + 19 (NCN) + 24 (NCP) + 16 (HP) = 79 samples per operator. (Operator 1)
    • MET300: 4 (Negative) + 13 (LN) + 23 (NCN) + 20 (NCP) + 20 (HP) = 80 samples per operator. (Operator 1)
    • TML100: 2 (Negative) + 18 (LN) + 18 (NCN) + 19 (NCP) + 20 (HP) = 77 samples per operator. (Operator 1)
    • Total (approximate, as numbers vary slightly between operators): ~79+80+77 = ~236 clinical samples for AMP300, MET300, TML100 combined.
  • Data for other drugs refer to previous 510(k) clearances.
  • Data Provenance: Retrospective, using "unaltered clinical samples." No specific country of origin is mentioned.

• Lay-User Study:

  • Sample Size: 280 lay persons tested the device.
    • Configuration 1: 66 male + 74 female = 140 lay persons.
    • Configuration 2: 87 male + 53 female = 140 lay persons.
  • Data Provenance: Retrospective, samples were "prepared at the following concentrations; negative, +/-75%, +/-50%, +/-25% of the cutoff by spiking drugs into drug free-pooled urine specimens." Confirmed by LC/MS. Conducted "at three intended user sites." No specific country of origin is mentioned.

3. Number of Experts and Qualifications for Ground Truth (Clinical Samples)

• Ground Truth Establishment for Clinical Samples: LC/MS (Liquid Chromatography/Mass Spectrometry) is stated as the preferred confirmatory method and was used to confirm the concentrations of the samples. This is an objective chemical method, considered the gold standard for drug detection and quantification in urine.
• Experts: The comparison studies were performed "in-house with three laboratory assistants." While these individuals are performing the rapid tests, the ultimate ground truth is established by the LC/MS results. The "laboratory assistants" are not explicitly designated as "experts" in establishing ground truth, but rather as trained users of the device whose results are compared to the LC/MS gold standard.

4. Adjudication Method for the Test Set (Clinical Samples)

• The document states that "Operators ran unaltered clinical samples for each drug. The samples were blind labeled and compared to LC/MS results."
• There were three operators. The "Discordant Results" tables show discrepancies between the rapid test results and the LC/MS results, sometimes across multiple operators for the same sample.
• No explicit adjudication method (e.g., 2+1, 3+1) for the rapid test results themselves is described. The comparison seems to be a direct comparison of each operator's rapid test result against the LC/MS ground truth, and then discrepancies are noted. The LC/MS data serves as the final, objective ground truth.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• This document describes performance characteristics of an in-vitro diagnostic device (a qualitative urine drug test cup).
• No MRMC comparative effectiveness study was performed in the context of comparing human readers (e.g., radiologists interpreting images) with and without AI assistance. This type of study design is specific to AI/CADe (Computer-Assisted Detection) or CADx (Computer-Assisted Diagnosis) devices in imaging, which is not applicable to a lateral flow immunoassay like the AssureTech Quick Cup Tests.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Given this is a physical immunoassay test cup, the concept of a "standalone (algorithm only without human-in-the-loop performance)" study does not directly apply in the same way it would for a software-based AI device.
• The "Comparison Studies" with laboratory assistants and the "Lay-user study" assess the device's performance when interpreted by human users. The device itself, by producing a visual result (line/no line), is the "algorithm." Its performance is inherently tied to human interpretation of that visual output. The precision and specificity studies represent the analytical performance of the device itself.

7. Type of Ground Truth Used

• Analytical Performance Studies (Precision, Specificity, pH/SG Effect): The ground truth was established by spiking known concentrations of drugs into negative urine samples, with concentrations confirmed by LC/MS.
• Comparison Studies (Clinical Samples): The ground truth was established by LC/MS results on unaltered clinical urine samples. LC/MS is a highly accurate chemical analytical method.
• Lay-User Study: Ground truth was established by spiking known concentrations of drugs into drug-free pooled urine specimens, confirmed by LC/MS.

8. Sample Size for the Training Set

• This document describes a 510(k) submission for a traditional in-vitro diagnostic device (immunoassay). It does not mention any artificial intelligence (AI) or machine learning (ML) components that would typically require a "training set" in the computational sense.
• The terms "training set" and "test set" are common in AI/ML validation. For a traditional medical device, the studies described (precision, interference, specificity, comparison, lay-user) serve as the "validation set" against pre-defined performance criteria.
• Therefore, N/A for "training set" in the context of AI/ML.

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

• N/A (as above, no "training set" in the AI/ML context).
• However, if we consider how the device itself was developed, the ground truth for optimizing its performance (e.g., antibody binding, membrane characteristics) would have relied on highly controlled experiments with known concentrations of analytes, likely confirmed by advanced analytical chemistry methods like LC/MS. This process is part of the extensive R&D and quality control that precedes a 510(k) submission.

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The AssureTech Panel Dip Tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cocaine, Methamphetamine, Fentanyl, Norfentany], Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, EDDP, Nortriptyline and d-Propoxyphene in human urine at the cutoff concentrations listed. The single or multi-test panels can consist of up to seventeen (17) of the above listed analytes in any combination. 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 method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. For in vitro diagnostic use only.

The AssureTech Quick Cup Tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cocaine, Methamphetamine, Fentanyl, Norfentany], Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, EDDP, Nortriptyline and d-Propoxyphene in human urine at the cutoff concentrations listed. The single or multi-test panels can consist of up to seventeen (17) of the above listed analytes in any combination. 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 method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. For in vitro diagnostic use only.

The AssureTech Multi-drug Urine Test Panel are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Cocaine, Marijuana, Methamphetamine, Morphine, Fentanyl, Norfentanyl, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, EDDP, Nortriptyline, d-Propoxyphene and adulterants in human urine at the cutoff concentrations listed. The single or multi-test panel can consist of up to seventeen (17) of the above listed analytes in any combination. It is for in vitro diagnostic use only. 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 is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

The AssureTech Multi-drug Urine Test Cup are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Marijuana, Methamphetamine, Morphine, Fentanyl, Norfentanyl, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, EDDP, Nortriptyline, d-Propoxyphene and adulterants in human urine at the cutoff concentrations listed. The single or multi-test cups can consist of up to seventeen (17) of the above listed analytes in any combination. It is for in vitro diagnostic use only. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

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, Fentanyl, 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 FDA 510(k) premarket notification for AssureTech Panel Dip Tests and Quick Cup Tests, which are in vitro diagnostic devices for qualitative and simultaneous detection of various drugs of abuse in human urine. The document focuses on demonstrating substantial equivalence to a predicate device (K181768).

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

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this type of device are primarily related to its analytical performance, specifically its ability to accurately detect the presence or absence of target drugs at specified cutoff concentrations. The device is a qualitative test, meaning it provides a "positive" or "negative" result, rather than a quantitative measurement.

The study demonstrates performance through:

• Precision: Consistency of results across multiple runs and lots, especially near the cutoff concentrations.
• Specificity: Ability to react only with the target drug/metabolite and not with other substances or structurally similar compounds.
• Interference: Lack of false positives/negatives due to common interfering substances in urine, or variations in urine specific gravity and pH.
• Method Comparison: Agreement of device results with a known, more precise reference method (LC/MS).
• Lay-user study: Evaluation of the device's performance when used by non-professionals, assessing ease of use and accuracy of interpretation.

Here is a table summarizing the reported device performance for Fentanyl (FYL), Norfentanyl (NFYL), and as an example for another drug, Amphetamine (AMP) from the "Lay-user study" data. The document does not explicitly state numerical "acceptance criteria" for each performance metric, but rather presents the results of the studies conducted to show sufficient performance for regulatory clearance. The implicit acceptance criterion for a qualitative test like this is generally very high accuracy, especially around the cutoff, and a low rate of false positives/negatives.

Table of Performance for Key Drugs (Fentanyl, Norfentanyl, Amphetamine)

Precision Study (Fentanyl - Panel Dip/Quick Cup, Norfentanyl - Panel Dip/Quick Cup):
The precision data is presented for three lots and various concentrations relative to the cutoff. The data shows very high consistency. For instance, for Fentanyl:

• At -100%, -75%, -50% cut off (negative range), all 50 tests across 3 lots consistently yielded negative results (50-/0+).
• At +25%, +50%, +75%, +100% cut off (positive range), all 50 tests consistently yielded positive results (50+/0-).
• At the cutoff concentration, the device shows variability, as expected for tests near the decision threshold. For Fentanyl Panel Dip, results were 28+/22-, 29+/23-, 28+/22- for Lot 1, 2, 3 respectively (meaning some tests were positive and some negative at the cutoff). This variability is inherent for qualitative tests around the cutoff and implies that some samples at the cutoff may read positive and others negative, which is acceptable performance for a qualitative test. Similar patterns are observed for Quick Cup Fentanyl, Panel Dip Norfentanyl, and Quick Cup Norfentanyl.

Method Comparison Study (Fentanyl - Panel Dip/Quick Cup, Norfentanyl - Panel Dip/Quick Cup):
This study compared the device results against LC/MS, the preferred confirmatory method. The results are presented in tables showing agreement across different concentration ranges (Negative, Low Negative, Near Cutoff Negative, Near Cutoff Positive, High Positive).

Example for FYL (Fentanyl) - Panel Dip, Operator 1:

• Negative (LC/MS 0): Device: 0 Positive, 1 Negative (1 discordant result here, sample 1484, LC/MS 0.78 ng/mL, Device: +)
• Low Negative (LC/MS +50%): Device: 20 Positive, 0 Negative

Lay-User Study (Selected data for AMP, FYL, NFYL):
This study evaluates the percentage of correct results when used by lay persons at various concentrations relative to the cutoff.

Example for AMP (Amphetamine):

• Negative (100% below cutoff): 100% correct (0 positive, 20 negative)
• Low Negative (-75% to -25% Cutoff): 100% correct negative for -75% and -50%, but 0 positive/20 negative for -25% cutoff.
• Positive (+25% to +75% Cutoff): Generally high correctness (95%-100%). For +25% cutoff, 95% correctness (19 positive, 1 negative).

Detailed Study Information:

1. Sample sizes used for the test set and the data provenance:

   • Precision Study: For Fentanyl and Norfentanyl, the reported data is for 3 lots, with 2 runs per day for 25 days, for 9 concentrations (e.g., -100% cutoff, -75% cutoff, etc.). This implies 50 tests per concentration per lot (2 runs * 25 days), leading to 450 tests per drug type per lot (9 concentrations * 50 tests), and 1350 tests per drug type across all 3 lots. The data provenance implies these samples were prepared by spiking known concentrations of drug into negative samples, indicating a controlled laboratory environment. Data for other analytes was "reported in K181768" (the predicate device documentation), so the exact sample sizes are not explicitly stated in this document but are assumed to be similar.
   • Method Comparison Study: For Fentanyl and Norfentanyl, 80 unaltered clinical samples (40 negative and 40 positive based on LC/MS results) were used per drug. Each sample was tested by three laboratory assistants for each device type (Panel Dip and Quick Cup). This means 80 samples * 3 operators = 240 tests per drug for each device type. The data provenance is "in-house" and "unaltered clinical samples." The document does not specify the country of origin, but given the FDA submission, it's likely US-based or compliant with US standards. The study appears to be retrospective, using already collected clinical samples for comparison.
   • Lay-user Study: 280 lay persons were used for each device format (Panel Dip and Quick Cup, though the results summarized apply to the overall device type). Urine samples were prepared at 7 different concentrations (negative, +/-25%, +/-50%, +/-75%, +/-100% of cutoff). Each participant received one blind-labeled sample and one device. Assuming each person tested one sample, this implies 280 samples were tested for each specific drug evaluated by lay-users on each format. The data provenance: "samples were prepared by spiking drugs into drug-free pooled urine specimens" and confirmed by LC/MS. This is a controlled experimental set-up rather than real-world patient samples.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Precision Study: Ground truth was established by spiking known concentrations of drugs into negative samples and confirmed by LC/MS. No human experts were involved in establishing the ground truth directly for this part.
   • Method Comparison Study: The ground truth was established by LC/MS (Liquid Chromatography-Mass Spectrometry), which is explicitly stated as the "preferred confirmatory method" and is considered a gold standard for drug detection and quantification in urine. No human expert readers established the ground truth; it was a laboratory instrument measurement. The study used three laboratory assistants to read the device results, but they were comparing their readings against the LC/MS truth, not establishing the truth themselves. Their qualifications are not specified beyond "laboratory assistants."
   • Lay-user Study: The ground truth was established by spiking known concentrations of drugs confirmed by LC/MS. No human experts established the ground truth of the samples. The study assessed the lay-users' ability to interpret the device results against this known truth.

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

   • Precision Study: No adjudication method mentioned as samples were prepared with known concentrations.
   • Method Comparison Study: No adjudication method was explicitly mentioned for the device results. Each of the three operators performed their own reads, and their individual results were compared to the LC/MS. Discordant results are noted for each operator.
   • Lay-user Study: No adjudication method was mentioned. Each lay user tested one sample against a pre-defined truth.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted in this report. This device is a rapid diagnostic test (lateral flow immunoassay), not an AI-assisted diagnostic tool for interpretation of medical images or other complex data. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.

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

   • This is a lateral flow immunoassay, which is a physical diagnostic device producing a visual result (colored lines). It does not involve an "algorithm" in the sense of a software-based AI or computational algorithm. The device itself is the "standalone" diagnostic. Its performance characteristics (precision, specificity, interference) are essentially its "algorithm only" performance. The method comparison study is akin to assessing the device's standalone performance against a gold standard. The lay-user study assesses human interpretation of the device's standalone output.

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

   • The primary ground truth for the analytical and method comparison studies was Liquid Chromatography-Mass Spectrometry (LC/MS), which is a highly accurate chemical method for detecting and quantifying substances.
   • For the precision and lay-user studies, the ground truth was based on spiked urine samples with known drug concentrations, which were then confirmed by LC/MS.

7. The sample size for the training set:

   • This document describes a 510(k) premarket notification for an in vitro diagnostic device (lateral flow immunoassay). Unlike AI/ML-driven devices that require extensive training data, such chemical-based devices are developed and optimized through chemical engineering and biological principles, not by "training" on datasets in the AI sense. Therefore, the concept of a "training set" with a statistical sample size as understood in machine learning is not applicable to this type of device. The development process involves chemical formulation and validation, not data training.

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

   • Since the concept of a "training set" as it pertains to AI/ML devices is not applicable, the establishment of ground truth for a training set is also not relevant in this context. The "ground truth" for the performance evaluation of the device relied on LC/MS results and carefully prepared spiked samples with known drug concentrations.

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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 document describes the performance characteristics and studies for the AssureTech Panel Dip Tests and AssureTech Quick Cup Tests, which are qualitative drug detection devices for human urine.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for qualitative drug tests are typically based on the correct classification of samples, especially around the cutoff concentration. The reported device performance is presented as the percentage of correct results at various concentrations relative to the cutoff. For the purpose of this table, "Acceptance Criteria" will be interpreted as the expectation of high accuracy, particularly at concentrations significantly above or below the cutoff, and reasonable performance around the cutoff. The data provided primarily focuses on the "lay-user study" for all drugs listed.

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

• Analytical Performance (Precision, Specificity, Interference, Effect of Urine Specific Gravity and pH):

  • Sample Size: For precision studies, samples were prepared at various concentrations (-100% to +100% cutoff). Each concentration was tested with 3 lots of devices, 2 runs per day for 25 days, resulting in 50 individual tests per concentration per lot (2 runs/day * 25 days = 50). This totals approximately 400 tests per drug per lot per device type (8 concentrations * 50 tests).
  • For Interference, Specificity, and Effect of Urine Specific Gravity/pH studies, urine samples were tested using three lots of each device at 25% below and 25% above Cut-Off levels (and drug-free urine for interference). Specific sample numbers are not explicitly stated for these sub-studies but imply multiple tests per lot.
  • Data Provenance: The analytical studies were performed in-house, meaning within the manufacturer's or an affiliated laboratory. The data is thus prospective for the purpose of these device validations. The "country of origin" is not explicitly stated for the source of base urine samples, but the manufacturer is based in Hangzhou, China. The drugs were "spiked" into negative samples.

• Comparison Studies (with GC/MS):

  • Sample Size: 80 unaltered clinical samples (40 negative and 40 positive) for each drug (AMP500, COC150, MET500) were used for each device (Panel Dip and Quick Cup).
  • Data Provenance: The samples were "unaltered clinical samples," implying these were real-world samples. The study was performed in-house. The country of origin of these clinical samples is not specified, but given the manufacturer's location, they are likely from China or a region where the manufacturer has access to clinical samples. This is a retrospective analysis against a gold standard.

• Lay-user study:

  • Sample Size: 310 lay persons for each device format (Panel Dip and Quick Cup). Urine samples were prepared at various concentrations (-100%, -75%, -50%, -25%, +25%, +50%, +75% of the cutoff). The exact breakdown of how these 310 lay users were distributed across the different concentrations is shown in the tables (e.g., for AMP, 20 samples at -100% Cutoff, 170 at -50% Cutoff, etc., which sums to 310).
  • Data Provenance: The urine samples were "spiked drugs into drug free-pooled urine specimens." This indicates the samples were laboratory-prepared, not unaltered clinical samples. The study was conducted at "three intended user sites," but their location (country) is not specified. This is a prospective study using simulated clinical samples.

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

• Analytical Performance (Precision, Specificity, Interference): Ground truth established by LC/MS (Liquid Chromatography/Mass Spectrometry), which is an analytical chemical method, not by human experts. The drug concentrations in spiked samples were confirmed by LC/MS.
• Comparison Studies (with GC/MS): Ground truth established by GC/MS (Gas Chromatography/Mass Spectrometry), which is the gold standard confirmatory method for drug testing. This is a laboratory-based analytical method, not human expert interpretation.
• Lay-user study: Ground truth established by LC/MS to confirm the drug concentrations in the spiked urine samples.

It's important to note that for these in vitro diagnostic devices, the "experts" in establishing ground truth are typically the highly precise analytical instruments (GC/MS, LC/MS) not human readers as would be the case for imaging studies.

4. Adjudication Method (e.g. 2+1, 3+1, none) for the Test Set

• Analytical Performance & Lay-user study: No adjudication method explicitly described as the ground truth was an objective measurement by LC/MS. The results are compared directly to the known spiked concentrations confirmed by LC/MS.
• Comparison Studies (with GC/MS): No adjudication method explicitly described. The device results were compared directly against the GC/MS results. The "Viewers" (human operators) for the dip cards/quick cups for AMP, COC, and MET showed some discordant results with GC/MS, but there is no mention of a process to adjudicate these discrepancies among the viewers or with the GC/MS result.

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 MRMC comparative effectiveness study was done. The device is a rapid test (lateral flow immunoassay) which relies on visual interpretation of lines, not complex image analysis or AI.
• The "Comparison Studies" involved three "laboratory assistants" (referred to as Viewer A, B, C) manually interpreting the device results against GC/MS. This is a multi-reader study, but it's not a comparative effectiveness study of human readers with vs. without AI. It assesses the consistency of human interpretation of the device results.

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

• This question is not applicable. The devices are qualitative lateral flow immunoassays designed for human visual interpretation. They are not AI algorithms; their performance is intrinsically tied to human reading. The "Performance Characteristics" section covers the analytical performance of the device components themselves, independent of human interpretation to a logical degree (e.g., cross-reactivity, stability).

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

• The ground truth used for all performance studies (Analytical Performance, Comparison Studies, and Lay-user study) was analytical confirmation by either LC/MS or GC/MS. These are highly sensitive and specific laboratory methods considered the gold standard for drug detection and quantification in urine.

8. The sample size for the training set

• The document describes the performance of a rapid diagnostic test device (immunoassay), not a machine learning or AI algorithm that typically requires a distinct training set. Therefore, there is no specific "training set" as understood in the context of AI/ML development mentioned for the device itself.
• The device's internal parameters (e.g., antibody binding characteristics) would be developed and optimized by the manufacturer during product development, but this process doesn't constitute a "training set" in the AI sense.

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

• As there is no "training set" for an AI/ML algorithm mentioned, this question is not applicable. The device's performance is based on its inherent chemical and immunological properties.

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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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