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The FaStep™ Pregnancy Rapid Test Strip is a rapid, visual immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine. The test is an in-vitro diagnostic strip intended for use as an aid in the early detection of pregnancy. The FaStep™ Pregnancy Rapid Test Strip is designed for self-testing use.

The FaStepTM Pregnancy Rapid Test Midstream is a rapid, visual immunoassay for the qualitative detection of human chorionic gonadotropin(hCG) in urine. The test is an in-vitro diagnostic device intended for use as an aid in the early detection of pregnancy. The FaStep™ Pregnancy Rapid Test Midstream is designed for self-testing use.

FaStepTM Pregnancy Rapid Test Strip is sold as a strip format and FaStepTM Pregnancy Rapid Test Midstream is sold as a midstream format. Pregnancy Rapid Test Midstream consists of a single test strip assembled in a plastic housing, with an absorbent tip, and is designed to be tested in dip or midstream mode. FaStep™ Pregnancy Rapid Test Strip is a single test strip. FaStep™ Pregnancy Rapid Test Midstream contains one test sealed in a desiccated aluminum pouch and Instructions for Use. FaStep™ Pregnancy Rapid Test Strip contains one test strip sealed in a desiccated aluminum pouch and Instructions for Use. The device is in a ready-to-use format and does not require assembly before use.

The provided text is a 510(k) Summary for the FaStep™ Pregnancy Rapid Test Strip and FaStep™ Pregnancy Rapid Test Midstream. It details the performance characteristics used to demonstrate substantial equivalence to a predicate device.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a "table of acceptance criteria" with predefined numerical targets for performance metrics. Instead, it describes various studies and their outcomes, implying that the acceptance criterion for each test was a successful demonstration of performance (e.g., no false positives/negatives at specific concentrations, 100% conformity).

However, we can infer the implicit acceptance criteria from the study design and reported "100% conformity" with results from professional testing or the predicate device. The primary performance characteristic where a specific numerical sensitivity is stated is 20 mIU/mL.

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

• Analytical Performance (Sensitivity/Precision/Reproducibility):
  • For each hCG concentration (0, 10, 12.5, 15, 17.5, 20, 50, 100, 200 mIU/mL): 10 replicates per day for 5 days per device lot, tested by 3 operators.
  • Total tests per hCG concentration per device format (Strip, Midstream in-stream, Midstream dip): 10 * 5 * 3 = 150 tests.
  • Data provenance: Not explicitly stated where the urine samples were collected, but they were "spiked with hCG standard". This is a laboratory-controlled study.
• Specificity: 300 urine samples from normal, non-pregnant females (100 pre-menopausal, 100 peri-menopausal, 100 post-menopausal).
• Method Comparison Study: 267 urine samples from women presenting to test for pregnancy (139 pregnant, 128 non-pregnant - determined by predicate). Used for both FaStep™ Pregnancy Rapid Test Strip (N=140 subset) and FaStep™ Pregnancy Rapid Test Midstream (N=127 subset).
• Lay Person Study: Same sample sizes as the Method Comparison study, using the same subjects (140 for Strip, 127 for Midstream).
• Data provenance: Retrospective or prospective is not explicitly stated. The samples for the method comparison and lay person studies were "collected from women presenting to test for pregnancy," which suggests a more prospective real-world sample collection, although the overall study itself is likely a retrospective analysis of collected samples for regulatory submission. Country of origin not specified, but the submitter is from Hangzhou, China.

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

• Analytical Performance (Sensitivity/Precision/Reproducibility): The ground truth (hCG concentration) was established by spiking with hCG standard traceable to the 5th WHO. The tests were performed by "three different operators." Their qualifications are not specified beyond being "operators." This appears to be a laboratory-controlled study rather than using clinical experts to establish ground truth.
• Specificity Study: The ground truth for specificity (non-pregnant) seems to be based on the source of the urine samples ("normal, non-pregnant female"). No explicit expert adjudication process is described for confirming this.
• Method Comparison Study: The ground truth was established by the predicate device. The text states "All samples were tested with candidate and predicate devices at three POC sites." While a predicate device serves as the reference, it's not "expert opinion."
• Lay Person Study: The ground truth was established by "professional testing." The number and qualifications of these "professionals" are not specified in the document.

4. Adjudication Method for the Test Set

• Analytical Performance: No adjudication method is explicitly stated. The results were visually read by the operators (implied), and then aggregated.
• Specificity, Cross-Reactivity, Interfering Substances, Hook Effect: These were laboratory studies with results determined by the test reactivity. No human adjudication is mentioned.
• Method Comparison and Lay Person Study: No explicit adjudication method (e.g., 2+1 or 3+1) is mentioned. The professional results (ground truth for lay person study) and predicate device results (ground truth for method comparison) appear to be taken as definitive.

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, an MRMC comparative effectiveness study was NOT done. This device is a rapid, visual immunoassay for qualitative detection of hCG in urine. It is not an AI-assisted diagnostic device, nor does it involve human readers interpreting complex images or data where AI assistance would be relevant. The "lay person study" is a comparison of lay users vs. professional results for the device itself, not AI assistance for human readers.

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

• This question is not applicable as this is a qualitative immunoassay test kit, not an algorithm or software. The device itself is "standalone" in that it produces a visual result directly. The "professional" testing mentioned in the lay person study implies a human interpreting the device, but the device's mechanism is not an AI algorithm.

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

• Analytical Performance (Sensitivity): Spiking with WHO traceable hCG standard.
• Specificity, Hook Effect, Cross-Reactivity, Interfering Substances: Laboratory-controlled studies using spiked samples or naturally occurring non-pregnant/specific samples, with the expected outcome (positive/negative) serving as ground truth.
• Method Comparison Study: The predicate device's results served as the ground truth.
• Lay Person Study: "Professional results" served as the ground truth. The nature of these professional results (e.g., expert interpretation of the device, or results from a laboratory reference method) is not explicitly detailed but implies a more definitive and reliable determination than the lay person's self-test.

8. The Sample Size for the Training Set

• This information is not provided. The document describes clinical and analytical performance studies (i.e., test set data) for regulatory submission, but does not detail the development or training of any underlying models, as this is a biochemical assay, not an AI/ML device requiring distinct training and test sets in the typical sense.

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

• Not applicable, as this is a biochemical immunoassay and does not involve AI/ML models with training sets and associated ground truth establishment methods. The document primarily focuses on validation testing and performance characteristics.

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AssureTech DOA Dipstick Screen Panel Tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of 6-Monoacetylmorphine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine. Methadone, EDDP. Nortriptyline and d-Propoxyphene in human urine at the cutoff concentrations of.
Configuration of the AssureTech DOA Dipstick Screen Panel 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.

AssureTech DOA Integrated Cup Tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of 6-Monoacetylmorphine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine. Methadone, EDDP. Nortriptyline and d-Propoxyphene in human urine at the cutoff concentrations of.
Configuration of the AssureTech 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 DOA Dipstick Screen Panel Tests and AssureTech DOA Integrated Cup Tests are immunochromatographic assays that use a lateral flow system for the qualitative detection of 6-Monoacetylmorphine, 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 DOA Dipstick Screen Panel 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 text describes the performance characteristics of the AssureTech DOA Dipstick Screen Panel Tests and AssureTech DOA Integrated Cup Tests, which are in vitro diagnostic devices for detecting drugs of abuse in human urine.

Here's a breakdown of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for these devices are implicitly defined by the satisfactory performance in the analytical studies (precision, interference, specificity, effect of urine specific gravity and pH) and method comparison studies. The goal is for the device to correctly identify positive and negative samples, especially around the established cutoff concentrations.

A formal table of explicit acceptance criteria (e.g., minimum sensitivity/specificity percentages) is not provided directly in the text as such for "acceptance criteria." However, the reported device performance in the precision study demonstrates that the device performs as expected. For samples with drug concentrations further away from the cutoff (e.g., -100%, -75%, -50% for negative; +25%, +50%, +75%, +100% for positive), the device consistently yields the correct result (100% agreement: 30-/0+ for negative ranges and 30+/0- for positive ranges). Around the cutoff, there is some variability, which is expected for qualitative tests. For instance, at the cutoff, the positive results range from 22+/8- to 29+/1- out of 30 tests, meaning 22 to 29 out of 30 tests correctly identified as positive, and the remaining were negative. Conversely, for samples at -25% of the cutoff, all 30 tests were negative, and for samples at +25% of the cutoff, all 30 tests were positive.

For the purpose of this request, I will synthesize the implied acceptance criteria from the study design and report the performance based on the precision study across all evaluated drugs and device types, focusing on the key ranges around the cutoff.

Performance at Cutoff: At the cutoff concentration, the number of positive results out of 30 varied by drug and lot, ranging from 22+/8- (e.g., COC, MDMA, THC) to 29+/1- (BZO). This indicates generally good, though not perfect, agreement with the cutoff.

Performance at -25% Cutoff: All samples at -25% of cutoff consistently yielded negative results (30-/0+ across all drugs and lots). |
| Specificity | No interference from common physiological/pathological substances or non-target drugs/metabolites at specified concentrations. | Interference: Over 100 common substances (e.g., acetaminophen, ethanol, hemoglobin, ibuprofen) showed no interference at 100ug/mL (or 1% for ethanol, 100 mg/dL for albumin).

Cross-Reactivity (6-MAM): Only 6-acetylmorphine showed 100% cross-reactivity at the cutoff. Diacetylmorphine (heroin precursor) showed 1% cross-reactivity at 1000 ng/mL, Hydromorphone and Nalorphine showed 0.2% cross-reactivity at 5000 ng/mL, and Morphine showed 0.1% at 10000 ng/mL. Most other listed substances showed 10000 ng/mL).

Cross-Reactivity (THC): 11-nor-D*-THC-9 COOH and 11-nor-D8-THC-9 COOH showed 100% cross-reactivity. Other tested cannabinoids showed 10000 ng/mL. |
| Stability | Device remains stable for a specified shelf-life under defined storage conditions. | Devices are stable at 4-30 ℃ for 24 months based on accelerated stability at 45 °C and real-time stability at 4 °C and 30 °C. |
| Effect of Urine SG/pH| Device performance should not be significantly affected by variations in urine specific gravity (SG) or pH within physiological ranges. | For urine samples with SG 1.000-1.035 and pH 4-9, results were all positive for samples at and above +25% Cut-Off and all negative for samples at and below -25% Cut-Off. This indicates no significant effect. |

2. Sample Sizes and Data Provenance

• Test Set Sample Size (Precision Study): For each drug and each of the two device types (Dipstick Screen Panel and Integrated Cup), three different lots were tested. For each lot, 9 different drug concentrations (from -100% to +100% of cutoff) were evaluated. Each concentration was tested 30 times (1 run per lot per day for 10 days, across three POC sites, implying 30 tests per concentration per lot).
  • Therefore, for a single drug and a single device type: 3 lots * 9 concentrations * (implied 1 test per concentration per run * 10 days * 3 sites / 3 lots) = 3 lots * 9 concentrations * 30 tests = 810 tests.
  • For the two device types and 16 drugs: 2 * 16 * 810 = 25,920 individual qualitative test results (excluding controls).
• Test Set Sample Size (Method Comparison Study): For each drug (6-MAM and THC20 explicitly detailed, with a note that "the rest data were reported in the K181768"), a total of 80 unaltered clinical urine samples were tested. These 80 samples consisted of 40 negative samples and 40 positive samples. The positive samples were further categorized into "Near Cutoff Positive" (15 samples) and "High Positive" (25 samples). The negative samples were categorized into "Negative" (10 samples), "Low Negative" (20 samples), and "Near Cutoff Negative" (10 samples).
  • These 80 samples were tested for each of the two device types (Dipstick Screen Panel and Integrated Cup).
  • Each sample result was reviewed by 3 "Viewers" (human readers). So, for one drug and one device type, it's 80 samples * 3 viewers = 240 observations.
• Data Provenance:
  • Precision Study: Samples were "prepared by spiking drug in negative samples." The text doesn't specify the origin of the "negative samples." The study was conducted in a controlled lab setting, essentially creating a prospective dataset.
  • Method Comparison Study: "Unaltered clinical samples" were used. The country of origin is not explicitly stated. The study design of using "clinical samples" retrospectively analyzed against a gold standard (LC/MS) suggests these were real-world samples.

3. Number of Experts (Viewers) and Qualifications for Ground Truth in Test Set

• Ground Truth for Precision Study: The ground truth was established by LC/MS (Liquid Chromatography/Mass Spectrometry), which is an analytical chemical method considered the gold standard for drug detection and quantification in urine. No human experts were involved in establishing the ground truth for this part of the study.
• Ground Truth for Method Comparison Study: The ground truth for the clinical samples was established by LC/MS.
• Human Readers (Viewers): While not establishing ground truth, the method comparison study mentions "Viewer A," "Viewer B," and "Viewer C" who ran and interpreted the tests. Their qualifications are not explicitly stated in the provided text. It's implied they were trained operators at the POC (Point of Care) testing sites.

4. Adjudication Method for the Test Set

• For the precision study, results were either positive or negative based on visual interpretation, directly compared to the known spiked concentration relative to the cutoff. No explicit adjudication method is mentioned as the results are discrete (positive/negative based on line presence at a known concentration).
• For the method comparison study, the results for each sample were recorded by "Viewer A," "Viewer B," and "Viewer C." The tables show individual viewer results, implying no formal adjudication process (like 2+1 or 3+1 consensus) was applied between the viewers. Each viewer's interpretation was directly compared against the LC/MS ground truth. Discordant results highlight instances where a viewer's reading differed from the LC/MS.

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

• A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly described in the provided text to assess how much human readers improve with AI vs. without AI assistance. The study evaluates the standalone performance of the rapid diagnostic device (Dipstick/Cup) and human interpretation of those devices against LC/MS, not human performance with or without AI assistance. The devices themselves are the "AI" analog (the automated detection method).

6. Standalone (Algorithm Only) Performance

• Yes, a standalone performance study was done. The AssureTech DOA Dipstick Screen Panel Tests and AssureTech DOA Integrated Cup Tests are described as "competitive binding, lateral flow immunochromatographic assays." These are point-of-care devices that produce a visual result (a colored line) indicating presence or absence of a drug. While human interpretation is involved, the device itself is the "algorithm" that produces the result. The precision and specificity studies directly evaluate the performance of these devices in a controlled, standalone manner, where the output is a qualitative visual signal. The method comparison study further tests this standalone device performance with human interpretation against a golden standard.

7. Type of Ground Truth Used

• The primary ground truth used in both the precision and method comparison studies was LC/MS (Liquid Chromatography/Mass Spectrometry). This is a highly accurate and quantitative analytical method used to confirm and quantify drug concentrations in urine samples.

8. Sample Size for the Training Set

• The provided document is a 510(k) summary for a rapid diagnostic test (lateral flow immunoassay). These types of devices are typically developed and optimized through iterative design and testing processes that involve numerous samples during the research and development phase. However, the 510(k) summary focuses on the validation studies demonstrating the device's performance for regulatory clearance. It does not explicitly describe a "training set" in the context of machine learning. The studies described are performance evaluation studies, not algorithm training studies.

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

• Since a "training set" for an AI algorithm is not explicitly mentioned or relevant to the nature of these immunoassay devices, there is no information provided on how ground truth for such a set would have been established. The ground truth for the performance evaluation (test set) samples was established using LC/MS.

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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.

Ask a specific question about this device

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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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, Cannabinoids, Methamphetamine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxymethamphetamine. Phencyclidine and Methadone in human urine at the cutoff concentrations of.
The tests are intended for over-the-counter and for prescription use.

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 and Methadone (target analytes) in human urine. The tests are the first step in a two-step process. The second step is to send the sample for laboratory testing if preliminary positive results are obtained.

The AssureTech Panel Dip Tests comprise two items, a urine collection cup and the dip card with a plastic casing as the lateral flow device. The AssureTech Quick Cup Tests comprise a urine collection cup and a quick cup test with a lateral flow device that will start when the cap is screwed onto cup.

The provided text describes the performance characteristics and acceptance criteria for the AssureTech Panel Dip Tests and AssureTech Quick Cup Tests, which are qualitative drug screening devices.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for qualitative drug tests are typically defined by the performance at and around the cutoff concentration. The data presented shows excellent performance for samples well below and well above the cutoff, with some expected variability around the cutoff.

The tables provide the raw results rather than a single aggregated performance metric (like accuracy, sensitivity, or specificity relative to a cutoff for the entire dataset). However, we can infer the performance based on these results. For samples significantly below the cutoff, the device should consistently report negative results. For samples significantly above the cutoff, it should consistently report positive results. Near the cutoff, there's a transition zone where both positive and negative results are expected, and the reported numbers reflect this.

Let's illustrate with an example for Oxazepam (-25% cutoff, which is 225 ng/mL). The "Panel Dip" table shows for Lot 1: 9-/41+ (9 negative, 41 positive out of 50 samples). This means 41 samples with concentrations at 225 ng/mL were correctly identified as positive (or transitioning to positive). Similarly, for +25% cut off (375 ng/mL), it's 50+/0- (50 positive, 0 negative), indicating consistent positive detection.

Here's a summary table derived from the provided precision data for Oxazepam, Methylenedioxy-methamphetamine, and Morphine, illustrating the device performance relative to the acceptance criteria (consistent results at extremes, transition near cutoff). The "acceptance criteria" for these qualitative tests at different concentration levels are implied by the expected outcome (all negative for greatly reduced concentrations, all positive for greatly increased concentrations, and a mix near the cutoff).

Inferred Acceptance Criteria vs. Reported Performance (from Precision Studies)

Note on Acceptance Criteria: For qualitative tests like these, the acceptance criteria are generally that samples significantly below the cutoff (e.g., -50% to -100% of cutoff) should consistently yield negative results and samples significantly above the cutoff (e.g., +50% to +100% of cutoff) should consistently yield positive results. Around the cutoff (e.g., +/- 25% of cutoff), a mix of positive and negative results is expected, demonstrating the device's ability to discriminate at the threshold. The reported data generally supports this behavior.

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

• Precision Studies (Test Set):

  • For each drug and each concentration point (-100%, -75%, -50%, -25%, +25%, +50%, +75%, +100% cut off), and for each device (Panel Dip, Quick Cup), 50 samples per lot (2 runs per day for 25 days) for 3 lots were tested.
  • Total samples per drug/concentration point/device: 50 samples/lot * 3 lots = 150 samples.
  • Data Provenance: Samples were prepared by spiking drug in negative urine samples, and concentrations were confirmed by LC/MS. "In-house" studies are mentioned for comparison studies, suggesting the data was generated within the company or a collaborating lab. The document does not specify the country of origin of the data or whether the studies were retrospective or prospective, though the precision studies appear prospective due to the controlled spiking and testing regimen.

• Comparison Studies (Test Set):

  • For each drug and each device (Panel Dip, Quick Cup): 80 unaltered clinical samples (40 negative and 40 positive).
  • Data Provenance: "In-house" studies. Samples were "unaltered clinical samples", meaning they were real patient samples, and were blind labeled. The origin (country/retrospective/prospective) is not explicitly stated.

• Lay-user Study (Test Set):

  • For each device format (Panel Dip, Quick Cup): 280 lay persons per device format participated.
  • Urine samples were prepared at various concentrations (-100% Cutoff, -75% Cutoff, -50% Cutoff, -25% Cutoff, +25% Cutoff, +50% Cutoff, +75% Cutoff). The sample count varies for each concentration, but the total across all concentrations sums to 280 (e.g., 20+20+140+20+20+40+20 = 280) for each drug.
  • Data Provenance: "Lay users" at "three intended user sites." The data was generated in a controlled manner (spiking drugs into pooled urine, blind labeling, LC/MS confirmation). The document does not specify country.

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

• Precision Studies: Ground truth was established by LC/MS (Liquid Chromatography/Mass Spectrometry), which is an analytical method used for confirming drug concentrations. This is a highly accurate chemical method, not human expert consensus for visual interpretation.
• Comparison Studies: Ground truth was established by LC/MS results.
• Lay-user Study: Ground truth for sample concentrations was established by LC/MS.

No human experts were used to establish the ground truth in terms of visual interpretation for these studies as the ground truth was based on quantitative chemical analysis.

4. Adjudication Method for the Test Set

• Precision, Comparison, and Lay-user Studies: The ground truth for the spiked samples was determined by LC/MS. For the comparison studies, the "unaltered clinical samples" were also compared to "LC/MS results" as the ground truth.
• In the comparison studies, three laboratory assistants observed the results. The discordant results (where the viewer's result differed from the LC/MS) are listed in tables.
• No explicit "adjudication method" among human viewers (like 2+1 or 3+1 consensus) is described, as the ultimate ground truth was LC/MS. The individual viewer results are presented and compared against this gold standard.

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

• No, a typical MRMC comparative effectiveness study, which usually involves multiple human readers interpreting medical images or data with and without AI assistance to measure improvement, was not performed.
• This device is a qualitative drug screening test, where the result is a visible line (or absence of a line). The "readers" in the "Comparison Studies" are "laboratory assistants" observing these lines, not interpreting complex medical images. The study's focus is on the device's accuracy against a chemical gold standard, not human reader performance improvement with AI.

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

• Yes, for all studies (Precision, Comparison, Lay-user), the device operates in a standalone manner. The "human-in-the-loop" is simply reading the visual indicator (lines) produced by the device, not an "algorithm" making a diagnostic prediction that is then confirmed or refined by a human. The device itself is the "algorithm" in that it performs the chemical assay. The comparison data shows the device's inherent ability to produce the correct qualitative result based on the chemical content, which is then visually interpreted.

7. The Type of Ground Truth Used

• The primary type of ground truth used for all performance evaluations (precision, specificity, interference, comparison, and lay-user studies) was quantitative chemical analysis, specifically Liquid Chromatography/Mass Spectrometry (LC/MS). For the precision studies, concentrations were confirmed by LC/MS, and for the comparison studies, clinical samples were compared to LC/MS results.

8. The Sample Size for the Training Set

• This document describes a 510(k) submission for a diagnostic device. Such devices are typically developed, manufactured, and validated based on established chemical and immunological principles. They do not involve "training sets" in the context of machine learning or AI models.
• The "training" for such devices is in the design, formulation, and manufacturing process to ensure consistent chemical reactivity. There is no explicit "training set" of data points in the same sense as for an AI/ML algorithm.

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

• As stated above, there is no "training set" in the AI/ML sense for this type of device. The "ground truth" for developing the device would involve chemical principles, experimental optimization of reagents and concentrations, and quality control measures during manufacturing. This is a traditional immunoassay, not an AI/ML product.

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AssureTech Marijuana Tests are immunochromatographic assays for the qualitative determination of 11-Nor-△9-Tetrahydrocannabinol-9-COOH in human urine at cut-off concentration of 50 ng/mL. The tests are available in a Strip format, a Cup format, a Dip Card format and a Turn Key Split Cup format.

The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry 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.

For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.

AssureTech Methamphetamine Tests are immunochromatographic assays for the qualitative determination of d-Methamphetamine in human urine at cut-off concentration of 1000 ng/mL. The tests are available in a Strip format, a Cup format, a Dip Card format and a Turn Key Split Cup format.

The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry 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.

For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.

AssureTech Phencyclidine Tests are immunochromatographic assays for the qualitative determination of Phencyclidine in human urine at cut-off concentration of 25 ng/mL. The tests are available in a Strip format, a Dip Card format and a Turn Key Split Cup format.

The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry 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.

For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.

The AssureTech Methamphetamine Tests, AssureTech Phencyclidine Tests, and AssureTech Marijuana Tests are immunochromatographic assays that use a lateral flow system for the qualitative detection of d-Methamphetamine, Phencyclidine and Marijuana (target analytes) in human urine. The tests are the first step in a two-step process. The second step is to send the sample for laboratory testing if preliminary positive results are obtained.

The provided text describes the analytical and user performance of various AssureTech drug tests (Methamphetamine, Phencyclidine, and Marijuana) across different formats (Strip, Dip Card, Cup, Turn Key Split Cup). The information outlines specific studies conducted to demonstrate the device meets acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state quantitative acceptance criteria in percentages (e.g., "must achieve 90% accuracy"). Instead, it presents results for concentrations at or around the cut-off, and above/below it, demonstrating the device's ability to correctly identify positive and negative samples.

Here's a table summarizing the reported device performance for Methamphetamine, Phencyclidine, and Marijuana tests, based on the precision and comparison studies, which effectively serve as a demonstration of meeting implied acceptance criteria for qualitative immunoassay performance.

Implicit Acceptance Criteria: The device should consistently provide correct qualitative results (positive or negative) around and beyond the defined cut-off concentrations, as confirmed by a gold standard (GC/MS). For concentrations significantly below the cut-off, the device should report negative, and for concentrations significantly above, it should report positive. At the cut-off itself, there might be some variability, but a strong trend toward expected results is desired. The lay-user study indicates a high percentage of correct results.

Reported Device Performance (Excerpted and Summarized):

2. Sample Sizes and Data Provenance:

• Precision Studies: Samples were prepared at various concentrations around the cut-off (-100%, -75%, -50%, -25%, cut-off, +25%, +50%, +75%, +100%). For each concentration level, 50 tests were performed (2 runs per day for 25 days). This implies 450 tests per lot per device type for each drug (9 concentration levels * 50 tests). With 3 lots per device and 4 device formats for each of the 3 drugs, the total number of precision tests is substantial (e.g., 450 * 3 lots * 4 formats * 3 drugs = 16,200).

• Comparison Studies (Expert Review): For each drug and each device format, 80 unaltered clinical samples were used (40 negative and 40 positive). These were "blind labeled."

• Lay-user Study: 1638 lay persons participated. They were given blind-labeled urine samples from various concentration levels (Negative, +/-75%, +/-50%, +/-25% of the cutoff). The tables show results for 21 samples per concentration level, for each drug and each device type. Considering there are 7 concentration levels listed, and assuming all 4 formats for all 3 drugs were tested, this amounts to a significant number of samples tested by lay users (21 samples/level * 7 levels * 4 formats * 3 drugs = 1,764 total sample tests, which broadly aligns with "1638 lay persons").

• Data Provenance: The document states "Method comparison studies... were performed in-house..." and "Lay-user study was performed at three intended user sites." The country of origin is not explicitly stated for the clinical samples, but the submitting company is based in Hangzhou, China. The studies appear to be prospective as samples were prepared at specific concentrations and tested.

3. Number of Experts and Qualifications:

• Expert Review (Comparison Study): Three laboratory assistants ("Viewer A", "Viewer B", "Viewer C") were used to read the devices. Their specific qualifications (e.g., years of experience) are not provided in this excerpt, only their role as "laboratory assistants."
• Ground Truth Establishment: The ground truth for the test set (clinical urine samples) in the comparison studies was established using Gas Chromatography/Mass Spectrometry (GC/MS), which is stated as the "preferred confirmatory method" and considered a gold standard for drug detection. For precision studies, samples were "prepared by spiking drug in negative samples" and "Each drug concentration was confirmed by GC/MS."

4. Adjudication Method for the Test Set:

• No explicit adjudication method (e.g., 2+1, 3+1 consensus) is described for the "Viewer" results in the comparison studies. The results for each "Viewer" are presented independently. Discordant results are specifically listed, indicating individual discrepancies rather than a pooled or adjudicated outcome from the laboratory assistants.

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

• No MRMC comparative effectiveness study was done in the context of human readers improving with AI vs. without AI assistance. This document describes the performance of a standalone in vitro diagnostic device (immunochromatographic assay) and its comparison to a gold standard (GC/MS), along with a lay-user study. It does not involve AI assistance for human readers.

6. Standalone (Algorithm Only) Performance:

• The devices themselves are qualitative immunochromatographic assays which provide a visual result (line appears or not). Therefore, their performance, as described in the precision and comparison studies, is essentially standalone performance. There isn't an "algorithm" in the typical AI sense; the "algorithm" is the biochemical reaction and visual interpretation of the test strips/cups. The results tabulated for the "Viewers" (laboratory assistants) and "Lay persons" represent human interpretation of these standalone devices.

7. Type of Ground Truth Used:

• The primary ground truth used for validating the device performance is Gas Chromatography/Mass Spectrometry (GC/MS). This is a highly accurate chemical method for confirming the presence and concentration of specific substances in urine samples.
• For the lay-user study, the ground truth was also established by GC/MS of the prepared urine samples.

8. Sample Size for the Training Set:

• This document describes performance validation studies for a medical device (AssureTech drug tests), not an AI algorithm. Therefore, there is no "training set" in the context of machine learning. The device operates based on fixed immunochromatographic principles. The "precision" and "comparison" studies serve as validation of the device's inherent design and manufacturing consistency.

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

• As there is no AI algorithm training set, this question is not applicable. The device's operational principles are based on biochemical interactions, not learned patterns from a training dataset.

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AssureTech Amphetamine Tests are immunochromatographic assays for the qualitative determination of d-Amphetamine in human urine at cut-off concentration of 1000 ng/mL. The tests are available in a Strip format, a Dip Card format and a Turn Key Split Cup format.

The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry 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.

For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.

AssureTech Cocaine Tests are immunochromatographic assays for the qualitative determination of Benzoylecgonine in human urine at cut-off concentration of 300 ng/mL. The tests are available in a Strip format, a Dip Card format and a Turn Key Split Cup format.

The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry 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.

For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.

AssureTech Morphine Tests are immunochromatographic assays for the qualitative determination of Morphine in human urine at cut-off concentration of 2000 ng/mL. The tests are available in a Strip format, a Dip Card format and a Turn Key Split Cup format.

The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry 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.

For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.

The AssureTech Amphetamine Tests, AssureTech Cocaine Tests, and AssureTech Morphine Tests are immunochromatographic assays that use a lateral flow system for the qualitative detection of d-Amphetamine, Benzoylecgonine and Morphine (target analytes) in human urine. The tests are the first step in a two-step process. The second step is to send the sample for laboratory testing if preliminary positive results are obtained.

Here's a summary of the acceptance criteria and study details for the AssureTech Amphetamine, Cocaine, and Morphine Tests, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" as distinct, quantifiable thresholds for overall device performance (e.g., minimum sensitivity/specificity). Instead, it presents the results of various studies which demonstrate the device's acceptable performance in several analytical and user-related aspects. The performance is summarized below from the provided tables and text.

• Samples at -100%, -75%, -50% cut-off consistently showed 50-/0+ (negative results, 0 false positives).
• Samples at +25%, +50%, +75%, +100% cut-off consistently showed 50+/0- (positive results, 0 false negatives).
• At the cut-off concentration, results showed a mix of positive and negative, as expected (e.g., Amphetamine Strip Lot 1: 12-/38+; meaning 12 negative and 38 positive out of 50 tests). This demonstrates the ability to differentiate near the cut-off. |
  | Cut-off | Accurate detection at and around defined cut-off concentrations. | For all three drug tests:
• All samples at and above +25% Cut-Off were positive.
• All samples at and below -25% Cut-Off were negative.
  Verified Cut-off Values:
• d-Amphetamine: 1000 ng/mL
• Benzoylecgonine: 300 ng/mL
• Morphine: 2000 ng/mL |
  | Interference | No significant interference from common physiological/pathological substances or drugs. | No interference observed for a wide range of compounds (listed in detail for each drug) at 100µg/mL. No differences observed across different device formats. |
  | Specificity | Correct identification of target analytes and appropriate cross-reactivity with related compounds. | Detailed cross-reactivity tables provided, showing expected reactivity to metabolites and related compounds, and negative results for unrelated substances. For example:
• Amphetamine: D-Amphetamine 100%, L-Amphetamine 5%, D,L-Amphetamine 33%.
• Cocaine: Benzoylecgonine 100%, Cocaine HCl 40%.
• Morphine: Morphine 100%, Codeine 200%, Acetylmorphine 80%. |
  | Effect of Urine Specific Gravity and pH | No impact on results within biological ranges. | All samples spiked with target drugs at +/-25% Cut-Off within specific gravity (1.000-1.035) and pH (4-9) ranges yielded expected results (positive at +25% Cut-Off, negative at -25% Cut-Off). No differences observed across different device formats. |
  | Method Comparison (vs. GC/MS) | High concordance with GC/MS results, especially for samples far from the cut-off. Discordant results should be concentrated near the cut-off. | Generally high concordance with GC/MS. Discordant results (where device result differs from GC/MS) primarily occur in samples with concentrations near the cut-off (between -50% and +50% of the cut-off), which is an expected characteristic of qualitative rapid tests. Specific numbers of concordant and discordant results are detailed for each drug and device format. |
  | Lay-user Study (Correct Results) | High percentage of correct results by lay users for samples significantly above or below the cut-off. | For all three drug tests (Amphetamine, Cocaine, Morphine) and all device formats:
• 100% correct results for samples at -100%, -75%, -50% cut-off.
• 100% correct results for samples at +50%, +75% cut-off.
• Performance slightly lower (e.g., 90-95%) for samples near the +/-25% cut-off, which is expected for qualitative tests. |
  | Lay-user Study (Ease of Use) | Instructions easily understood and followed by lay users. | All lay users indicated that the device instructions could be easily followed. The Flesch-Kincaid reading analysis showed a Grade Level of 7 for the package insert. |

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

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

  • Precision: For each drug and each device format, 3 lots were tested. For each lot, 8 concentrations were evaluated, with 50 tests per concentration (2 runs per day for 25 days). This amounts to 3 (lots) * 8 (concentrations) * 50 (tests/concentration) = 1200 tests per drug per device format.
  • Cut-off: 150 samples (equally distributed at -50%, -25%, Cut-Off, +25%, +50% Cut-Off) were tested using three different lots of each device by three different operators. This sums up to 150 (samples) * 3 (lots) * 3 (operators) = 1350 tests per drug per device format.
  • Interference/Specificity/Effect of Urine Specific Gravity and pH: Samples were prepared with interfering substances/varied conditions and spiked with target drugs at 25% below and 25% above Cut-Off levels. Tested using three batches of each device. Specific sample numbers for these studies are not explicitly provided beyond these descriptions.
  • Data Provenance: Not specified, but generally analytical performance studies are conducted internally by the manufacturer. No country of origin is mentioned. These are retrospective studies in the sense that samples are prepared/manipulated for the experiment.

• Method Comparison Studies (vs. GC/MS):

  • For each drug and each device format, 80 unaltered clinical samples were tested by three laboratory assistants. These samples were categorised as 10 Negative, 20 Low Negative (less than -50%), 10 Near Cutoff Negative (between -50% and cutoff), 15 Near Cutoff Positive (between cutoff and +50%), and 25 High Positive (greater than +50%).
  • Total samples per drug (e.g., Amphetamine) across all device types: 80 (samples) * 4 (device formats) = 320 samples (clinical).
  • Total tests per drug: 80 (samples) * 3 (viewers) * 4 (device formats) = 960 tests (clinical).
  • Data Provenance: "Unaltered clinical samples" - implies prospective or retrospectively collected human urine samples. Country of origin not specified.

• Lay-user Study:

  • 1638 lay persons were involved. Each participant tested 1 blind-labeled sample.
  • Samples were prepared at 7 different concentrations for each drug and device (negative, +/-75%, +/-50%, +/-25% of the cutoff).
  • For each drug and each device format, there were 21 samples per concentration. So, 7 (concentrations) * 21 (samples/concentration) = 147 samples per drug per device format.
  • Therefore, 147 samples * 3 (drugs) * 4 (device formats) = 1764 samples in total for the lay-user study. Given there were 1638 lay persons, this suggests some lay persons might have tested multiple devices/drugs, or the "number of samples" refers to unique sample types at each concentration. The phrasing "Each participant was provided with... 1 blind labeled sample and a device" implies each of the 1638 participants tested one particular drug/device combination sample. The specific breakdown of which participant tested which of the 1764 total samples isn't detailed, but the total number of lay users is 1638.
  • Data Provenance: "three intended user sites." Implied prospective data collection from human lay users. Country of origin not specified.

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

• Analytical Performance & Lay-user Study Test Sets: The ground truth for these samples was established using GC/MS (Gas Chromatography/Mass Spectrometry). This is a highly accurate chemical method used as the "preferred confirmatory method" for drug testing. No human experts were involved in establishing the ground truth for these controlled samples; it's a quantitative chemical analysis.
• Method Comparison Study Test Set: The ground truth for the 80 unaltered clinical samples was also established through GC/MS.
• Qualifications of Experts: Not applicable, as GC/MS is the ground truth determinant. The "laboratory assistants" and "lay persons" were the ones performing the device tests, not establishing the ground truth.

4. Adjudication Method (for the test set):

• Analytical Performance & Lay-user Study: The ground truth was based on GC/MS results. The device results were compared directly to the GC/MS quantitative concentration relative to the cut-off. No human adjudication method was described as the ground truth was objective chemical analysis.
• Method Comparison Study: The ground truth was based on GC/MS results. Discordant results (where the viewer's result differed from the GC/MS) are reported individually for each viewer. There is no mention of an adjudication process among the three laboratory assistants (Viewers A, B, C) for these comparisons.

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, an MRMC comparative effectiveness study was not done. This document describes a medical device (drug screening tests) which is not an AI-powered image analysis tool. It is a qualitative immunoassay. The "Viewers" mentioned in the method comparison study are laboratory assistants reading the results of the strips, not radiologists or medical professionals interpreting AI output. Therefore, there is no discussion of AI assistance or effect size on human reader improvement.

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

• Yes, in essence, standalone performance data is presented, but not for an algorithm. The devices are qualitative immunochromatographic assays. Their "standalone" performance is assessed by comparing their output (presence/absence of a line, indicating positive/negative) directly against the GC/MS ground truth in various analytical studies (precision, cut-off, interference, specificity, specific gravity/pH effects).
  • The "Method Comparison Studies" where three laboratory assistants read the devices can be seen as testing the device's performance with a human-in-the-loop (laboratory assistant).
  • The "Lay-user study" specifically evaluates the device's performance with a human-in-the-loop (lay person), focusing on ease of use and ability to correctly interpret results.
  • The closest to "algorithm only" performance comes from the precision and cut-off studies, where the device's inherent ability to react to specific concentrations is measured.

7. The type of ground truth used:

• The primary ground truth used for all performance studies (analytical, method comparison, and lay-user studies) was Gas Chromatography/Mass Spectrometry (GC/MS).
• GC/MS is referred to as the "preferred confirmatory method," making it the clinical gold standard for quantitative drug concentration in urine, providing an objective and highly accurate ground truth.

8. The sample size for the training set:

• This document is a 510(k) submission for an in-vitro diagnostic device (immunoassay), not an AI/Machine Learning algorithm. Therefore, there is no concept of a "training set" in the traditional AI sense described here. The device's performance is based on its chemical and biological design, not on being trained with data.

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

• As there is no training set for an AI/ML algorithm, this question is not applicable. The device's functionality is inherent to its design as an immunoassay.

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