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Rapid Marijuana (THC) Test Strip 20 and Rapid Marijuana (THC) Test Dipcard 20 is a rapid, screening test for the qualitative detection of Marijuana and their metabolites in human urine at the cut-off concentration of 20 ng/mL.

Rapid Marijuana (THC) Test Strip 50 and Rapid Marijuana (THC) Test Dipcard 50 is a rapid, screening test for the qualitative detection of Marijuana and their metabolites in human urine at the cut-off concentration of 50 ng/mL.

The tests contain two formats:1) Test Strip and 2) Test Dipcard. The tests are intended for in vitro diagnostics use. They are intended for over-the-counter use.

The tests provide only a preliminary result. To obtain a confirmed analytical result, a more specific alternative chemical method must be used. Gas Chromatography/Mass spectrometry (GC/MS) or Liquid chromatography/Mass spectrometry (LC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained.

Rapid Marijuana (THC) Test Strip 20 and Rapid Marijuana (THC) Test Dipcard 20 are competitive binding, lateral flow immunochromatographic assays for qualitatively the detection of Marijuana and their metabolites at or above the cut-off concentration of 20 ng/mL. The tests can be performed without the use of an instrument.

Rapid Marijuana (THC) Test Strip 50 and Rapid Marijuana (THC) Test Dipcard 50 are competitive binding, lateral flow immunochromatographic assays for qualitatively the detection of Marijuana and their metabolites at or above the cut-off concentration of 50 ng/mL. The tests can be performed without the use of an instrument.

Test Strip and Test Dipcard use identical test strips made with same chemical formulation and manufacturing procedures.

This document describes the performance of the Rapid Marijuana (THC) Test Strip and Dipcard devices, available in 20 ng/mL and 50 ng/mL cutoff concentrations, for the qualitative detection of Marijuana and its metabolites in human urine.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria in terms of specific performance metrics (e.g., minimum sensitivity, specificity, or agreement percentages for accuracy studies). However, the performance data presented implies a standard of acceptable qualitative detection around the cutoff concentration. The precision and accuracy studies evaluate the device's ability to correctly identify positive and negative samples at various concentrations relative to the cutoff. The home-use study assesses user comprehension and ease of use.

Since no explicit numerical acceptance criteria are provided, I will present key performance indicators from the precision and accuracy studies. For the purpose of this table, I will infer that a high percentage of correct classifications at and around the cutoff, along with 100% correct classification for samples significantly above or below the cutoff, would be considered acceptable.

Inferred Performance Acceptance Criteria & Reported Device Performance for Cut-off 20 ng/mL:

Inferred Performance Acceptance Criteria & Reported Device Performance for Cut-off 50 ng/mL:

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

• Precision Study:
  • Sample Size: For each device type (Strip 20, Dipcard 20, Strip 50, Dipcard 50), 3 lots were tested. Each lot involved 60 determinations for each of 9 concentration levels, across 6 operators at 3 Point-of-Care sites over 10 non-consecutive days. This totals to 1620 observations per device type in the precision study.
  • Data Provenance: The document does not explicitly state the country of origin for the urine samples. The study involved spiking drug-free urine specimens. The study itself was conducted at 3 Point-of-Care sites, but their locations are not specified. It is a prospective study as samples were prepared and tested specifically for this evaluation.
• Accuracy Study:
  • Sample Size: 80 clinical urine specimens were used for each device type (Strip 20, Dipcard 20, Strip 50, Dipcard 50) and each operator site. Since there were 3 operator sites, this amounts to 80 * 3 = 240 tests (device results vs. LC/MS) for each specificity (20 ng/mL and 50 ng/mL).
  • Data Provenance: The samples were described as "clinical urine specimens," implying they were collected from human subjects. The country of origin is not specified, and it's unclear if they were retrospective or prospectively collected for the study.
• Home Use Consumer Study:
  • Sample Size: 180 lay users participated in the study. Each user performed 1 test on a provided specimen. The samples were prepared for the study. For each device type and concentration category, 30 determinations were made.
  • Data Provenance: The document does not specify the country of origin of the lay users or the urine samples used. It is a prospective study.

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

• Precision Study: The ground truth for the spiked samples was established by the precise concentration of "-)-11-nor-9-Carboxy-Δ⁹-THC" added to drug-free urine, confirmed with LC/MS. No human experts were involved in establishing this ground truth, as it was based on laboratory preparation and analytical confirmation.
• Accuracy Study: The ground truth for the clinical urine specimens was established by LC/MS (Gas Chromatography/Mass spectrometry or Liquid chromatography/Mass spectrometry). LC/MS is described as the "preferred confirmatory method." LC/MS is an analytical chemistry technique, not a human expert. Therefore, no human experts directly established the ground truth in this study; it was based on objective analytical measurement.
• Home Use Consumer Study: Similar to the precision study, the ground truth for samples was established by spiking drugs into urine with concentrations confirmed by LC/MS. No human experts were involved in establishing this ground truth.

4. Adjudication Method for the Test Set

• Precision Study: The results were read by operators comparing the test line intensity to the control line. There is no mention of an adjudication process for discrepancies in reading within the precision study; each determination (positive/negative) was recorded independently.
• Accuracy Study: The device results were compared directly to the LC/MS results. Discordant results are noted in tables (e.g., device positive when LC/MS was negative below cutoff, or device negative when LC/MS was positive above cutoff), but no formal adjudication method (like 2+1 reading) is described beyond this direct comparison.
• Home Use Consumer Study: The "Layer user Results" likely represent the interpretation of the test by the lay users themselves. No specific adjudication method is mentioned.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

There was no MRMC comparative effectiveness study done. The device is a rapid, screening immunoassay test (similar to a pregnancy test) for qualitative detection of THC metabolites in urine, designed for Over-The-Counter use. It is interpreted visually by the user or an operator. There is no AI component in this device, nor is there a comparison of human readers with vs. without AI assistance.

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

This is not applicable as the device is a lateral flow immunochromatographic assay requiring human visual interpretation. It is not an algorithm-only device. The results are read visually.

7. The Type of Ground Truth Used

• Cross-reactivity and Interference Studies: Ground truth was established by precisely preparing samples with known concentrations of various compounds and expected drug-free or drug-spiked urine.
• Precision Study: Ground truth for the concentration levels of (-)-11-nor-9-Carboxy-Δ⁹-THC was confirmed using LC/MS.
• Accuracy Study: Ground truth for clinical urine specimens was established by LC/MS (Gas Chromatography/Mass spectrometry or Liquid chromatography/Mass spectrometry).
• Home Use Consumer Study: Ground truth for the spiked samples was confirmed using LC/MS.

In summary, the primary ground truth method for quantitative confirmation of drug concentrations in samples was LC/MS.

8. The Sample Size for the Training Set

This information is not applicable to this device. As a rapid, screening immunoassay test, it does not involve machine learning or AI models that require a "training set." Its performance is based on the chemical reactions and visual detection inherent in the lateral flow assay.

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

This is not applicable as there is no training set for this device type.

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Rapid Single/Multi-drug test Cup and Rapid Single/Multi-drug test Dipcard are lateral flow chromatographic immunoassays designed to qualitatively detect the presence of drug metabolites in human urine at the following cut-off concentrations:

The tests contain two formats: 1) Test Cup and 2) Test Dipcard. The tests may be configured as single drug tests or multiple drug tests in any combination of the drug analytes listed in the table above. These tests are intended for in vitro diagnostics use. They are intended for prescription use including point of care sites and over-the-counter use. The tests will yield preliminary positive results when prescription drugs Barbiturates, Benzodiazepine, and Methadone are ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Barbiturates and Benzodiazepine in urine.

The assays provide only a preliminary analytical test result. Gas Chromatography/Mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.

Rapid Single/Multi-drug Test Cup and Rapid Single/Multi-drug Test Dipcard are competitive binding, lateral flow immunochromatographic assays for the qualitative detection of Amphetamine, Cocaine, Marijuana, Methamphetamine, Barbiturates, Benzodiazepines, Methylenedioxymethamphetamine, Methadone, Oxycodone, Phencyclidine and their metabolites ( specifically THC ) at or above the cut-off levels as indicated. The tests are performed without the use of an instrument.

The test cup and test dipcard formats use identical test strips made with the same chemical formulation and manufacturing procedures.

Here's a breakdown of the acceptance criteria and study information for the Rapid Single/Multi-drug Test Cup and Dipcard, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" for precision or accuracy studies in a quantitative manner (e.g., "must achieve X% agreement"). However, given the nature of the data presented, the implied acceptance criterion for precision is that the device should reliably identify samples at or above the cutoff as positive, and samples significantly below the cutoff as negative, with a reasonable degree of accuracy for concentrations near the cutoff. For accuracy, the implied acceptance criterion is that the device should demonstrate high agreement with GC/MS analysis. For lay user readability, the implied criterion is high user comprehension.

Let's synthesize the data into a table based on these implied criteria.

Note on "Reported Device Performance": The document provides raw numbers of positive/negative results at different concentration levels for precision and individual count breakdowns for accuracy against GC/MS. To create a concise table, I will report the general trends and highlight key metrics. Specific percentages are primarily for the lay-user study.

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

• Precision Study:
  • Sample Size: 60 determinations per lot per concentration (Total: 9 concentrations * 60 determinations/lot * 3 lots = 1620 observations for each drug type). This was for both single drug and multi-drug formats, and both cup and dipcard.
  • Data Provenance: Not explicitly stated, but based on the overall document, it is likely internal laboratory testing or conducted at the specified Point-of-Care sites, implying prospective. The "nonparticipant" blinding suggests a controlled, prospective design.
• Accuracy Study (Clinical Urine Specimens):
  • Sample Size: 80 clinical urine specimens for each drug type. These were divided into five categories (drug free, less than half cutoff, near cutoff negative, near cutoff positive, high positive).
  • Data Provenance: "Clinical urine specimens" suggests real-world samples. The study was conducted by nurses at two Point-of-Care sites, indicating prospective, real-world data collection using the device.
• Home Use Consumer Study:
  • Sample Size: 360 lay users. Urine samples were prepared at various concentrations (0, +/- 50% cutoff, +/- 25% cutoff, +100% cutoff). Each participant performed 1 test on a provided specimen.
  • Data Provenance: Prospective, controlled study with lay users using prepared samples.

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

• Precision Study: Ground truth was established by spiking known concentrations of drugs into drug-free urine. The concentrations were "confirmed with GC/MS." No human experts were used for ground truth directly for precision.
• Accuracy Study (Clinical Urine Specimens): The ground truth for the clinical urine specimens was established by Gas Chromatography/Mass Spectrometry (GC/MS) analysis. This is an analytical chemistry technique, not human expert interpretation.
• Home Use Consumer Study: Ground truth was established by spiking known concentrations of drugs into drug-free urine. The concentrations were "confirmed with GC/MS." No human experts were used for ground truth directly for the lay user study's analytical performance.

4. Adjudication Method for the Test Set

• Precision Study: The samples were "blindly labeled by a nonparticipant" and "randomized prior to testing." Results were qualitative (Positive/Negative) based on the device's output. No explicit multi-reader adjudication method (e.g., 2+1) is mentioned; it appears to be a direct comparison of the device's qualitative result to the known spiked concentration.
• Accuracy Study (Clinical Urine Specimens): "All samples were blindly labeled by a nonparticipant" and "randomized prior to testing." The device results were compared directly to the GC/MS analysis. No multi-reader adjudication is mentioned for the device's interpretation or the GC/MS results.
• Home Use Consumer Study: Each participant performed one test and filled out a questionnaire. The device's qualitative result (positive/negative) from the lay user was compared against the known spiked concentration. No explicit multi-reader adjudication is mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. This device is a qualitative in-vitro diagnostic (drug test cup/dipcard) that provides a direct positive or negative result, read by an individual (either a healthcare professional or a lay user). It is not an imaging AI device that assists human readers in interpreting complex medical images. Therefore, an MRMC comparative effectiveness study involving AI-assisted human readers is not applicable and was not performed.

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

Yes, in essence. The device itself is a standalone qualitative test. Its performance (producing a positive or negative line) is inherent to the device's chemical assay. While a human physically observes the lines, the "algorithm" is the chemical reaction and visual indicator built into the device. The precision and accuracy studies directly reflect this standalone chemical "algorithm's" performance against known concentrations or GC/MS. The lay user study evaluated the human reading the standalone device.

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

The primary ground truth used for evaluating the performance of the device was known spiked concentrations of drugs (confirmed by GC/MS) for precision and lay user studies, and Gas Chromatography/Mass Spectrometry (GC/MS) analysis for clinical accuracy studies. GC/MS is a highly accurate analytical method considered a gold standard for confirming the presence and concentration of drugs in urine.

8. The sample size for the training set

The document describes performance studies, but it does not mention a "training set" in the context of machine learning or AI models. This device is a lateral flow immunoassay, which does not typically involve training data in the AI sense. The design and validation of this type of device rely on analytical and clinical performance studies, not machine learning model training.

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

As there is no mention of a "training set" for an AI or machine learning model, this question is not applicable to the information provided in the document. The ground truth for the performance evaluation (test sets) was established through spiking known drug concentrations into urine and confirmation via GC/MS, as detailed in point 7.

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One Step Single/Multi-drug Test Cup and One Step Single/Multi-drug Test Dipcard are lateral flow chromatographic immunoassay designed to qualitatively detect the presence of drugs and drug metabolites in human urine at the following cut-off concentrations:

The tests contain two formats:1) Test Cup, 2) Test Dipcard, The test configuration comes with single drug screening test or any combinations of multiple drug screening tests. The test is intended for in vitro diagnostics use. They are intended for prescription use in clinical laboratories only and not for point-of-care use.

This assay provides only a preliminary analytical test result. Gas Chromatography/Mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.

One Step Single/Multi-drug Test Cup and One Step Single/Multi-drug Test Dipcard are competitive binding, lateral flow immunochromatographic assays for qualitatively the detection of Barbiturates, Benzodiazepines, Methylenedioxymethamine, Methadone, Oxycodone, Phencyclidine and their metabolites at or above the cut-off levels as indicated. The tests can be performed without the use of an instrument.

The provided document describes the Co-Innovation Biotech Co.,Ltd. One Step Single/Multi-drug Test Cup and One Step Single/Multi-drug Test Dipcard for qualitative detection of drugs of abuse in human urine. Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for qualitative immunoassay tests like these are typically assessed by comparing the device's results (positive/negative) against a gold standard (GC/MS) especially around the cutoff concentration. While explicit numerical acceptance criteria (e.g., % agreement, sensitivity, specificity targets) are not explicitly stated as 'acceptance criteria' in the document, the performance data implicitly serves as the demonstration that the device performs acceptably. The study evaluates the device's ability to correctly identify drug-free, less than half cutoff, near cutoff negative, near cutoff positive, and high positive samples.

The tables below synthesize the reported device performance for both the Test Cup and Test Dipcard formats for single and multi-drug tests, against the GC/MS analysis. The "Total" column in the original tables sums up the sample distribution across concentration categories, not the total number of samples processed for each drug test condition. The key performance indicator here is the consistency of results, particularly for samples around the cutoff concentration.

Device Performance for One Step Single/Multi-drug Test Cup & Dipcard (Single Drug Test Example - All Drugs follow similar pattern)

Analysis of Discordant Results (Example for Test Cup and Dipcard, Single and Multi-drug)

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

• Sample Size: 80 clinical urine specimens were used for each drug tested, for each device format (Single Drug Test Cup, Single Drug Test Dipcard, Multi-drug Test Cup, Multi-drug Test Dipcard). Therefore, for each drug, a total of 320 samples were analyzed (80 * 4). The samples were categorized into five groups based on concentration relative to the cutoff (drug-free, less than half the cutoff negative, near cutoff negative, near cutoff positive, and high positive).
• Data Provenance: The data is from "clinical urine specimens," implying human origin. However, the country of origin is not specified, and it is a retrospective analysis as the specimens were analyzed by GC/MS for comparison with the device.

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

• The ground truth was established by Gas Chromatography/Mass Spectrometry (GC/MS) analysis, which is considered the "preferred confirmatory method" for drug of abuse testing.
• No human "experts" are mentioned as having established the ground truth through consensus or individual reading of the device results for the purpose of the primary accuracy study. The device results were compared directly against the GC/MS findings.

4. Adjudication Method for the Test Set

• None in the traditional sense of multiple human readers adjudicating results. The device's qualitative results (positive/negative) were directly compared to the quantitative GC/MS results for each sample. Discordant results were individually listed with the GC/MS concentration.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, a MRMC comparative effectiveness study was not performed. The study's focus was on the standalone performance of the devices against a gold standard (GC/MS). Human readers' improvement with or without AI assistance is not relevant here as it's a diagnostic test that provides a clear positive/negative result, not an AI-assisted diagnostic imaging interpretation.

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

• Yes, this was a standalone performance study. The "One Step Single/Multi-drug Test Cup" and "One Step Single/Multi-drug Test Dipcard" are qualitative, lateral flow immunochromatographic assays designed to be read directly without an instrument or human interpretation loop beyond reading the presence or absence of test lines. The performance data presented directly reflects the device's output (positive/negative) compared to GC/MS.

7. The Type of Ground Truth Used

• The ground truth used was quantitative analytical data from Gas Chromatography/Mass Spectrometry (GC/MS), which is the preferred confirmatory method for drug of abuse testing. This is a highly objective and precise method for determining drug concentration.

8. The Sample Size for the Training Set

• This document describes a performance evaluation of a medical device, not an AI algorithm that requires a training set. Therefore, no training set for an algorithm is mentioned or applicable in this context. The devices are immunoassay tests, not machine learning algorithms.

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

• As mentioned above, there is no training set for an algorithm as the device is an immunoassay test.

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One Step Single/Multi-drug Test Cup Single/Multi-drug Test Dipeard are lateral flow chromatographic immunoassrys designed to qualitatively detect the presence of drugs and drug metabolites in human urine at or above the following cut-off concentrations:

Marijuana (THC) Calibrato r · Delta-9-THC-COOH Cut-off level 50 ng/ml.
Cocaine (COC) Benzoylecgonine 300 ng/ml.
Amphetamine (AMP) D-Amphetamine 1000 ng/ml.
Methamphetamine (MET) D-Methamphetamine 1000 ng/mL
Morphine 2000 (MOP) Morphine 2000 ne/ml.

The tests contain two formats: 1) Test Cup, 2) Test Dipeard. The test configuration comes with single drug sereening test or any combinations of multiple drug screening tests. The test is intended for in vitro diagnostics use. They are intended for preseription use in clinical laboratories only and not for point-of-care use.

These esss provide only a prefininary analytical test result and are the first step in a two-step process for detecting drugs of abuse in urine. The second step is continuing the results in a certified laboratory. For a quantitative result or to confirm preliminary positive positive positive results obtained by the One Step Multi-drug Test Cup Insert or One Step Single/Multi-drug Test Dipeard Insert, a more specific alternaire method such as Gas Chromatography/Mass Spectomerry (GCMS) must be used. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.

One Step Single/Multi-drug Test Cup and One Step Single/Multi-drug Test Dipcard are competitive binding, lateral flow immunochromatographic assays for qualitatively the detection of Amphetamine, Cocaines, Marijuana, Methamphetamine,Morphine and their metabolites at or above the cut-off levels as indicated. The tests can be performed without the use of an instrument.

The provided document describes the performance of the Co-Innovation Biotech Co., Ltd. One Step Single/Multi-drug Test Cup and Dipcard for the qualitative detection of drugs and drug metabolites in human urine.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" with numerical thresholds for performance metrics (like sensitivity, specificity, or agreement percentages). Instead, it presents the results of clinical studies (accuracy studies) designed to demonstrate the device's performance against a gold standard (GC/MS). The implied acceptance is that the device demonstrates a high level of agreement with GC/MS, especially near and above the cutoff concentrations.

For the purpose of this response, I infer the performance target is to achieve high agreement with GC/MS. The reported device performance is shown in the tables below, demonstrating the number of positive and negative results from the device compared to GC/MS at different concentration levels.

Performance Summary (based on provided data for both formats: Cup and Dipcard)

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

• Single Drug Test:
  • Test Set Size: 165-186 clinical urine specimens for each drug (AMP, COC, THC, MET, MOP) were used for each device format (Cup and Dipcard).
  • Data Provenance: The specimens were described as "clinical urine specimens," implying they were collected from human subjects in a real-world clinical setting. No specific country of origin is mentioned, but the submitter's address is in Guangzhou, P.R. China, suggesting the data may originate there. The study appears to be retrospective, as existing clinical specimens were analyzed.
• Multi-Drug Test:
  • Test Set Size: 80 clinical urine specimens for each drug were used for each device format (Cup and Dipcard).
  • Data Provenance: Similar to the single drug test, these were "clinical urine specimens." Provenance details are identical to the single drug test.

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

The ground truth was established by Gas Chromatography/Mass Spectrometry (GC/MS). This is a laboratory-based analytical method, not a human expert interpretation. Therefore, the concept of "number of experts" or their "qualifications" in the context of establishing ground truth does not apply as it would for image-based diagnostics. The accuracy of GC/MS itself is well-established as a confirmatory method for drug testing.

4. Adjudication Method for the Test Set

No human adjudication method (like 2+1, 3+1 consensus) was used. The study compared the device results directly against the quantitative results obtained from GC/MS. Discordant results (where the device and GC/MS disagreed) are individually listed with the specific drug concentration from GC/MS. This suggests that GC/MS was considered the definitive gold standard.

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

No MRMC comparative effectiveness study was done. This device is a biochemical assay (lateral flow immunoassay) for qualitative detection, not an AI-assisted diagnostic tool where human readers interpret medical images or data. The device provides a direct positive/negative result, not an interpretation that humans would then review.

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

Yes, this was effectively a standalone study. The device (One Step Single/Multi-drug Test Cup/Dipcard) itself produces a result (qualitative positive or negative) without human interpretation. The study evaluates the performance of the device only against the GC/MS ground truth. Human involvement is limited to performing the test procedure and reading the physical test line, which is a direct visual cue, not an interpretive task that would significantly affect the "algorithm's" performance.

7. The Type of Ground Truth Used

The ground truth used was GC/MS Analysis (Gas Chromatography/Mass Spectrometry). This is an objective, analytical method that provides quantitative drug concentrations in the urine specimens. It is considered the gold standard for drug confirmation.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" for the device. As an immunochromatographic assay, these devices are typically developed through bench-top experimentation and optimization of reagents and manufacturing processes, rather than machine learning training that would require a distinct "training set." The performance data provided is for the rigorous testing of the finalized device.

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

Since there is no explicit training set mentioned in the context of machine learning, this question is not directly applicable. The development and optimization of the immunoassay itself would rely on established biochemical principles and analytical methods to determine antigen-antibody reactions and cutoff sensitivities, likely using reference standards and known concentrations of drugs and metabolites during the R&D phase.

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The Co-Innovation One Step HCG Test Strip is an in vitro diagnostic visual qualitative immunochromatographic assay designed for the rapid determination of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. It is intended for over-the-counter (OTC) use.

The Co-Innovation One Step HCG Test Cassette is an in vitro diagnostic visual qualitative immunochromatographic assay designed for the rapid determination of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. It is intended for over-the-counter (OTC) use.

The Co-Innovation One Step HCG Test Midstream is an in vitro diagnostic visual qualitative immunochromatographic assay designed for the rapid determination of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. It is intended for over-the-counter (OTC) use.

Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test is a rapid sandwich immunoassay device designed for the qualitative determination of human chorionic gonadotropin (hCG) concentration in human urine samples, as an aid in the early detection of pregnancy. The test devices are in three different formats: Strip, Cassette and Midstream . Three test formats use identical strips and each test strip in the device consists of:

1. A conjugate pad contains colloidal gold conjugated with mouse monoclonal anti-B-HCG antibody specific to the beta subunit of hCG.

2. A nitrocellulose membrane which is striped with the mouse monoclonal anti-a-HCG antibody in the test line (T line) and goat anti-mouse IgG polyclonal antibody in the control line (C line).

The Cassette format has the same performance specifications as the Test Strip format. The difference is that the urine sample is dispensed by dropper onto the sample well on the cassette.

The Midstream format has the same performance specifications as the Test Strip format. The difference is that the device is placed into the urine stream or dipped into the urine collection cup for 5 seconds.

Here's an analysis of the provided 510(k) summary, detailing the acceptance criteria and the studies conducted to demonstrate the device's performance:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied by the successful outcomes presented in the study results, particularly for precision and sensitivity, as no explicit numerical acceptance targets are stated (e.g., "sensitivity must be >99%"). However, the performance data clearly demonstrates that the device meets the implicit requirement for accurate qualitative detection of HCG at the clinical cut-off of 25mIU/mL.

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

• Precision Study: 30 clinical samples (normal, non-pregnant female urine) were spiked with HCG at 6 different concentrations (0mIU/ml, 12.5mIU/ml, 18.75mIU/ml, 25mIU/ml, 50mIU/ml, 100mIU/ml). Each concentration had 30 samples tested per LOT, across 3 lots, yielding 90 tests per concentration per format. The study was conducted over 10 days, 3 runs/day.
  • Provenance: Clinical samples from "normal, non-pregnant females." The document does not explicitly state the country of origin, but the submitter is from Guangzhou, China, and the OTC user study sites are in Guangzhou, Shanghai, and Wuhan, suggesting a Chinese origin. The study appears to be a prospective experimental study using spiked samples.
• Specificity Study: 60 urine specimens (containing 0 mIU/ml and 25mIU/ml HCG) were spiked with LH, FSH, and TSH. Tested across 3 lots.
  • Provenance: Not explicitly stated, likely similar to precision study. Prospective experimental study.
• Interfering Substances Study: Normal, non-pregnant female urine specimens (0 and 25 mIU/ml HCG) were spiked with 11 different compounds. 3 batches of each format were tested for each interferent.
  • Provenance: Not explicitly stated, likely similar to precision study. Prospective experimental study.
• HCG ß-core fragment Interference Study: Normal, non-pregnant female urine specimens (0 and 25 mlU/ml HCG) were spiked with 4 different concentrations of HCG ß-core fragment. 3 batches of each format were tested.
  • Provenance: Not explicitly stated, likely similar to precision study. Prospective experimental study.
• pH Interference Study: Aliquoted negative urine pool adjusted to pH 3-9, spiked with 0mlU/ml and 25mlU/ml HCG. 3 batches were tested repeatedly.
  • Provenance: Not explicitly stated, likely similar to precision study. Prospective experimental study.
• Specific Gravity Interference Study: Purified water and 25mlUml HCG spiked specimens formulated with specific gravity 1.01-1.04. 3 lots tested.
  • Provenance: Not explicitly stated, likely similar to precision study. Prospective experimental study.
• Urinary System Diseases Interference Study: Urine specimens with strongly positive markers (white blood cells, occult blood, uric acid, urine ketone) prepared with 0mlU/ml and 25mlU/ml HCG. 3 lots tested repeatedly.
  • Provenance: Not explicitly stated, likely clinical samples. Prospective experimental study.
• HOOK Effect Study: HCG free specimens spiked with 5 different very high HCG concentrations (62,500mIU/m1 to 1,000,000mIU/ml). Three lots tested.
  • Provenance: Not explicitly stated, likely similar to precision study. Prospective experimental study.
• Professional Method Comparison: 353 urine samples collected from women at a hospital laboratory. "Approximately half of the women were pregnant in the early stage of less than 5 weeks." Ages 18-45 years.
  • Provenance: Clinical samples from a hospital laboratory. Not explicitly stated, but likely China given other study locations. Retrospective (samples collected, then tested) or prospective (samples collected specifically for the study) clinical study.
• Lay User Method Comparison: The same 353 urine samples as the Professional Method Comparison.
  • Provenance: Clinical samples, likely China. Retrospective or prospective clinical study.
  • Specific breakdown for lay users: 80 using strip, 113 using cassette, 160 using midstream (actual + dip methods combined).
• OTC User Performance: 240 female subjects (untrained operators, ages 18-45) tested masked spiked urine samples (120 containers of 18.75mlU/ml and 120 of 31.25mlU/ml). Each subject performed 1 test on one format/method.
  • Provenance: Samples were spiked. Subjects from Guangzhou, Shanghai, and Wuhan, China. Prospective experimental study (simulated home use).

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

• Precision, Specificity, Interference, pH, Specific Gravity, Urinary System Diseases, HOOK Effect Studies: The ground truth (HCG concentration, presence/absence of interferents) was established by spiking known concentrations of HCG or interfering substances, traceable to WHO standards or determined by immunoassay (ELISA). This does not involve human experts establishing ground truth for individual test samples, but rather analytical methods.
• Professional Method Comparison: The "ground truth" for this study was the result obtained by the predicate device when tested by laboratory professionals. The exact number of professionals is not specified, but the study was conducted at "two laboratories (namely Professional A and Professional B)", implying at least two professionals. Their qualifications are stated as "laboratory professionals."
• Lay User Method Comparison: The "ground truth" for this study was the result obtained by laboratory professionals using the candidate device. The number of laboratory professionals is not specified, but it was conducted at "a laboratory." Their qualifications are "laboratory professionals."
• OTC User Performance: The "ground truth" for this study was established by masked spiked urine samples (known HCG concentrations) and independently verified by professional laboratory personnel at the manufacturer site. The number of professionals is not specified, and their exact qualifications are not detailed beyond "professional laboratory personnel."

4. Adjudication Method for the Test Set

• For the analytical performance studies (Precision, Specificity, Interference, etc.), adjudication generally involves comparing the device's output to the known, spiked concentration or condition. There's no human adjudication process described beyond analytical confirmation of spike levels.
• For the Professional Method Comparison and Lay User Method Comparison, the comparison is against the predicate device or professional results of the candidate device. The agreement is tabulated directly, implying no specific "adjudication" if disagreement occurred, as 100% agreement was reported.
• For the OTC User Performance study, the lay users' results were compared against the "masked spiked sample professional users" results (i.e., known spiked concentration verified by professionals). Again, no specific adjudication process for discrepancies is described, as the focus is on the agreement rate.

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

There was no MRMC comparative effectiveness study done, as this device is a qualitative diagnostic test (HCG pregnancy test) not an imaging device typically analyzed by human readers with or without AI assistance. The studies involve human users (professional or lay) interpreting the test results visually, but not in a context typically requiring MRMC analysis.

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

This device is a visual qualitative immunochromatographic assay. There is no "algorithm" in the sense of a software-based AI. The performance is inherently "standalone" in that it produces a visual result (a line) and the interpretation is human-in-the-loop (reading the line). The "performance" studies are effectively standalone because they evaluate the test's ability to produce the correct visual output given an HCG concentration. The OTC user study then evaluates the human (lay user) interpretation of this visual output.

7. The Type of Ground Truth Used

• Spiked Samples (Precision, Specificity, Interference, Hook Effect, pH, Specific Gravity, Urinary System Diseases, OTC User Study): The ground truth was established by laboratory control, adding known concentrations of HCG (traceable to WHO 3rd IS) or interfering substances to urine samples. This is a form of analytical or engineered ground truth.
• Professional Method Comparison: The ground truth was the result from the predicate device.
• Lay User Method Comparison: The ground truth was the result from professional users testing the candidate device.

8. The Sample Size for the Training Set

There is no explicit training set described in this 510(k) summary. This type of device (lateral flow immunoassay) typically does not involve a machine learning model that requires a distinct "training set." The development process for such a device relies on chemical and biological engineering principles, optimization of reagents, and initial analytical testing, rather than an iterative machine learning training process with labeled data.

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

As no explicit training set for a machine learning algorithm is mentioned, pertinent to the nature of this device, the question of how ground truth was established for a training set is not applicable. The ground truth for the performance evaluations (test sets) was established as described in section 7.

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