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Wondfo Propoxyphene Urine Test is an immunochromatographic assay for the qualitative determination of d-Propoxyphene in human urine at a cutoff concentration of 300 ng/mL. The test is available in a dip card format and a test cup format. It is intended for prescription use and over the counter use. The test provides only preliminary test results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. The test will yield preliminary positive results when prescription drug d-Propoxyphene is ingested, even at or above therapentic doses. There is no uniformly recognized cutoff concentration for d-Propoxyphene. It is not intended to distinguish between prescription use or abuse of this drug. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

The Wondfo Propoxyphene Urine Test uses immunochromatographic assays for d-Propoxyphene. The test is a lateral flow system for the qualitative detection of d-Propoxyphene in human urine. The test is 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 breakdown of the acceptance criteria and study information for the Wondfo Propoxyphene Urine Test devices, as extracted from the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document primarily focuses on a "Lay-user study" for establishing performance in the context of an OTC claim addition. The acceptance criteria for this study are implied by the desired percentage of correct results for various d-Propoxyphene concentrations relative to the 300 ng/mL cutoff. While explicit numerical acceptance criteria (e.g., "must achieve X% accuracy") are not stated, the study demonstrates desired performance.

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

• Sample Size for Test Set:
  • Lay-user study: 280 lay persons in total, with 140 testing the cup format and 140 testing the dip card format. Each lay person tested one blind-labeled sample.
  • For each concentration level represented in the table above, there were 20 samples for the cup format and 20 samples for the dip card format.
• Data Provenance: The document does not explicitly state the country of origin for the data or if it was retrospective or prospective. Given that the submitter is Guangzhou Wondfo Biotech Co., Ltd. from China, and the study was performed "at three intended user sites," it's likely the samples and study were conducted in China, and it appears to be a prospective study designed for this submission.

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

• Number of Experts: Not applicable in the context of expert review for ground truth in this lay-user study.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The "ground truth" was established independently by GC/MS and then compared directly to the lay user's interpretation.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not explicitly mentioned or performed in the provided text. The study described is a lay-user study comparing the device's output (as interpreted by lay users) against a gold standard (GC/MS).

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

• Standalone Performance: The Wondfo Propoxyphene Urine Test is an immunochromatographic assay, which is a rapid diagnostic test interpreted by a human. Therefore, the concept of a "standalone algorithm" doesn't directly apply in the same way it would for a digital imaging AI device. The lay user study is a test of human-in-the-loop performance, where the human interprets the result of the assay. The results for the cup and dip card formats are reflective of the final human-interpreted output.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth for the test samples was established by Gas Chromatography/Mass Spectrometry (GC/MS). The document states: "The concentrations of the samples were confirmed by GC/MS."

8. The Sample Size for the Training Set

• Sample Size for Training Set: The document does not describe a distinct "training set" in the context of machine learning. The device is an immunochromatographic assay, not an AI/ML algorithm that requires training data. Its "training" would involve internal development and optimization by the manufacturer using various chemical and biological samples, but this is not detailed in the provided regulatory document.

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

• Ground Truth for Training Set: Not applicable as there is no described AI/ML training set. The assay's performance relies on the specific antibodies and reagents designed to detect propoxyphene, and its development would involve internal validation by the manufacturer using known standards and clinical samples, confirmed typically by methods like GC/MS.

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Healgen Propoxyphene Test is an immunochromatographic assay for the qualitative determination of Propoxyphene in human urine at a Cut-Off concentration of 300 ng/mL. The test is available in a Strip format, a Dip Card format and a Cup format.

The test may yield preliminary positive results even when the prescription drug Propoxyphene is ingested, at prescribed doses; it is not intended to distinguish between prescription use or abuse of this drug. There is no uniformly recognized cutoff concentration level for Propoxyphene in urine. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the prefered 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. It is intended for prescription and for over-the-counter use.

Healgen Nortriptyline Test is an immunochromatographic assay for the qualitative determination of Nortriptyline in human urine at a Cut-Off concentration of 1000 ng/mL. The test is available in a Strip format, a Dip Card format and a Cup format.

The test may yield preliminary positive results even when the prescription is ingested, at prescribed doses, it is not intended to distinguish between prescription use or abuse of this drug. There is no uniformly recognized cutoff concentration level for Nortriptyline in urine. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the prefered 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. It is intended for prescription and for over-the-counter use.

Healgen EDDP (Methadone Metabolite) Test is an immunochromatographic assay for the qualitative determination of EDDP (2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine) in human urine at a Cut-Off concentration of 300 ng/mL. The test is available in a Strip format, a Cassette format, a Dip Card format and a Cup format.

The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. It is intended for prescription and for over-the-counter use.

Healgen Propoxyphene Test, Healgen Nortriptyline Test and Healgen EDDP (Methadone Metabolite) Test are immunochromatographic assays for Propoxyphene, Nortriptyline and EDDP. Each assay test is a lateral flow system for the qualitative detection of Propoxyphene, Nortriptyline and EDDP (target analyte) in human urine. The products are in vitro diagnostic devices, which come in the form of: Strips, Cassettes, DipCards, or Cups. Each product contains a Test Device (in one of the four formats), and a package insert. Each test device is sealed with a desiccant in an aluminum pouch.

The provided document describes the performance characteristics of the Healgen Propoxyphene Test, Healgen Nortriptyline Test, and Healgen EDDP (Methadone Metabolite) Test, which are immunochromatographic assays for the qualitative determination of these substances in human urine. The acceptance criteria and the studies performed to demonstrate the device meets these criteria are detailed.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" as a separate, quantified threshold for each performance characteristic. Instead, it presents the results of various analytical and comparison studies, implying that the observed performance meets the manufacturer's internal standards for claiming substantial equivalence to a predicate device. For the purpose of this response, I will interpret the reported performance in the precision and cut-off studies as the de facto acceptance criteria demonstrated by the manufacturer.

The key acceptance criterion for qualitative drug tests is typically the ability to correctly classify samples as positive or negative relative to a defined cut-off concentration. For samples precisely at or near the cut-off, some variability is expected.

Implicit Acceptance Criteria and Reported Performance (Based on "Precision" and "Cut-off" Studies):

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Wondfo Cannabinoids Urine Test and Wondfo Propoxyphene Urine Test are intended for the qualitative determination of 11-nor-A9-THC-9-COOH and d-propoxyphene (target analyte) at the specific cut-off concentration in human urine. For in vitro diagnostic use only. Wondfo Propoxyphene Urine Test is only intended for prescription use. Wondfo Cannabinoids Urine Test is intended for over-the-counter and prescription use.

Wondfo Propoxyphene Urine Test is an immunochromatographic assay for the qualitative determination of d-Propoxyphene in human urine at a cutoff concentration of 300 ng/mL. The test is available in a dip card format and a cup format. This product is only intended for prescription use.

Wondfo Cannabinoids Urine Test is an immunochromatographic assay for the qualitative determination of 11-nor-A9-THC-9-COOH (major metabolite of Cannabinoids) in human urine at a cutoff concentration of 50 ng/mL. The test is available in a dip card format and a cup format. It is intended for prescription use and over the counter use.

Immunochromatograph assay for Cannabinoids and Propoxyphene Urine Test using a lateral flow, one step system for the qualitative detection of 11-nor-Δ9-THC-9-COOH and d-propoxyphene (target analyte) in human urine. Each assay uses a monoclonal antibody-dye conjugate from mouse against drug with gold chloride and fixed drug-protein conjugate and anti-mouse IqG polyclonal antibody in membrane.

This document describes the Wondfo Cannabinoids Urine Test and the Wondfo Propoxyphene Urine Test, both qualitative immunochromatographic assays for detecting specific drug metabolites in human urine.

Here's an analysis of the provided information regarding acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state quantitative "acceptance criteria" or a "reported device performance" table in the typical sense (e.g., sensitivity, specificity thresholds with corresponding results). Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through similar technological characteristics and intended use. The performance is assessed by comparison to the predicate devices.

However, based on the context of drug screening devices and the comparison tables, we can deduce the key performance characteristics that are considered equivalent.

Note: The FDA's substantial equivalence determination implies that the performance of the Wondfo devices is comparable to that of the predicate devices for their stated indications. Specific quantitative performance data (e.g., precision, accuracy percentages) is not included in this summary but would typically be part of a full 510(k) submission.

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

The provided document does not specify the sample size used for any test set or the data provenance (e.g., country of origin, retrospective/prospective). This information is typically detailed in the performance study reports submitted as part of the 510(k), but it is not summarized here.

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

The document does not provide information on the number of experts used or their qualifications for establishing ground truth. For drug testing devices, ground truth is typically established using a reference method like Gas Chromatography-Mass Spectrometry (GC/MS).

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the test set. This would typically be relevant for studies involving human interpretation or subjective assessments, which isn't directly applicable to the core function of these immunoassay devices. If a study involved comparing the device's output to a confirmatory method, the "adjudication" would be based on the result of the confirmatory method.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed, nor is it applicable to these devices. These are standalone diagnostic test devices (immunoassays) that produce a qualitative result (positive/negative) based on a chemical reaction, not on human interpretation of complex images or data where "human readers improve with AI vs. without AI assistance" would be relevant.

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

Yes, the studies supporting these devices are inherently standalone performance studies. The devices themselves are designed to operate without human intervention in result generation; the reading of the test strip/cup is a direct visual interpretation of the chemical reaction. The comparison to predicate devices, and underlying performance studies (though not detailed here), would be based on the device's ability to accurately detect the target analytes.

7. Type of Ground Truth Used

Based on common practices for drug testing devices, the type of ground truth used would almost certainly be a confirmatory analytical method, specifically Gas Chromatography-Mass Spectrometry (GC/MS). Both indications for use statements explicitly mention GC/MS as the preferred confirmatory method for obtaining a confirmed analytical result.

8. Sample Size for the Training Set

The document does not specify the sample size for any training set. These devices are immunoassays that rely on established chemical principles; they typically do not involve machine learning algorithms that require "training sets" in the same way modern AI/ML devices do. Performance data would be collected from clinical samples to validate the device.

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

As these devices do not utilize a "training set" in the context of machine learning, this question is not applicable. The underlying validation of the immunoassay chemistry would be established through analytical studies using controlled samples with known concentrations of the target analytes, and then validated with clinical samples where truth is established by a confirmatory method like GC/MS.

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The UCP Rapid TM Drug Screening Tricyclic Antidepressant Test and UCP Rapid™ Drug Screening Propoxyphene Test are rapid, qualitative, competitive binding immunoassays for the detection of Tricyclic Antidepressants, Propoxyphene and their metabolites in human urine at the following cutoff levels:

The tests provide only preliminary data, which should be confirmed by other methods such as gas chromatography/mass spectrometry (GC/MS). The test configuration comes with either single drug test or in combination with multiple other drug tests. Clinical considerations and professional judgment should be applied to any drug of abuse test results, particularly when preliminary positive results are indicated. The tests are not intended to be used in monitoring drug levels.

UCP Rapid 100 Drug Screening Tricyclic Antidepressant, Propoxyphene Tests are competitive binding, lateral flow immunochromatographic assays for qualitatively the detection of Tricyclic Antidepressant, Propoxyphene and their metabolites at the cut-off levels as indicated. The tests can be performed without the use of an instrument.

Acceptance Criteria and Study for UCP Rapid™ Drug Screening TCA, PPX Tests

This response describes the acceptance criteria and the study conducted to demonstrate the device meets these criteria, based on the provided 510(k) submission.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for each drug screening test were set against established predicate devices and confirmed by gold standard methods. The reported performance refers to the accuracy demonstrated in the clinical comparison study.

Note: The document explicitly states the "performance of ≥ 98% for all drugs when performance was compared to a legally marketed device and HPLC or GC/MS."

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

• Sample Size for Test Set: 128 clinical urine specimens per drug.
  • This included approximately 10% of specimens with the target drug at concentrations between -50% of the cut-off and the cut-off.
  • Another 10% of specimens contained the target drug at concentrations between the cut-off and +50% of the cut-off.
  • Total 64 positive clinical urine specimens and 64 negative clinical urine specimens were tested against each drug.
• Data Provenance: The document does not explicitly state the country of origin. It describes them as "clinical urine specimens." The study is described as a "clinical comparison study," implying prospective collection for the study purpose or retrospective use of clinically collected samples. Without more detail, it's hard to definitively state prospective or retrospective, but the phrasing suggests a dedicated collection or selection process for the study.

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

The establishment of ground truth for the test set did not involve human experts in the traditional sense (e.g., radiologists interpreting images). Instead, the ground truth was established by laboratory analytical methods.

4. Adjudication Method for the Test Set

Not applicable. The ground truth was established by objective laboratory analytical methods (HPLC or GC/MS), not by expert consensus requiring adjudication.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is an in-vitro diagnostic test for qualitative detection of drugs in urine, not an imaging device requiring human reader interpretation or AI assistance for human readers.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone performance study was done. The "UCP Rapid™ Drug Screening Tricyclic Antidepressant Test" and "UCP Rapid™ Drug Screening Propoxyphene Test" are described as competitive binding, lateral flow immunochromatographic assays that "can be performed without the use of an instrument" and provide "visual, qualitative end results." The accuracy study directly assesses the performance of these devices in isolation against predicate devices and analytical gold standards.

7. Type of Ground Truth Used

The type of ground truth used was objective laboratory analytical methods:

• High-Performance Liquid Chromatography (HPLC)
• Gas Chromatography/Mass Spectrometry (GC/MS)

All test results from the UCP Rapid™ devices and the predicate devices were "confirmed with HPLC or GC/MS analysis."

8. Sample Size for the Training Set

The document does not specify a separate "training set" sample size. This type of device (lateral flow immunoassay) typically does not involve machine learning algorithms that require a distinct training phase with a labeled dataset in the same way modern AI algorithms do. The development and optimization of such assays rely on biochemical principles, antibody-antigen binding characteristics, and extensive experimental validation, rather than algorithmic training on a dataset. The performance data presented is for validation, not for training.

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

As there is no explicitly defined "training set" in the context of an AI/machine learning algorithm for this device, the concept of establishing ground truth for a training set does not apply directly. The development of the assay would have involved extensive R&D and optimization using various known concentrations of analytes, where the "ground truth" (i.e., the known concentration and presence/absence of the drug) would be intrinsically understood and controlled during the development process.

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Propoxyphene Plus is an in vitro diagnostic test for the qualitative and semi- quantitative detection of propoxyphene and its metabolites in human urine on automated clinical chemistry analyzers at a cutoff of 300 ng/ml. Semi- quantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program. Measurements obtained by this device are used in the diagnosis of propoxyphene use or abuse and do not measure a level of toxicity.

Propoxyphene Plus provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical 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 used.

The Roche ONLINE DAT Propoxyphene Plus assay is an in vitro diagnostic test for the qualitative and semi-quantitative detection of propoxyphene and its metabolites in human urine on automated clinical chemistry analyzers at a cutoff of 300 ng/ml. Semi-quantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program.

The ONLINE DAT Propoxyphene Plus assay is based on the kinetic interaction of microparticles in a solution (KIMS technology). Assay measurement is based on measurable changes in light transmission related to the interaction of microparticles in a solution and the sample drug of interest, if present. Propoxyphene drug derivative is conjugated to microparticles in solution, and propoxyphene polyclonal antibody (goat) is solubilized in buffer. In the absence of sample drug, free antibody binds to drug- microparticle conjugates causing the formation of particle aggregates. As the aggregation reaction proceeds in the absence of sample drug, the absorbance increases.

When a urine sample contains the drug in question, this drug competes with the particle-bound drug derivative for free antibody. Antibody bound to sample drug is no longer available to promote particle aggregation, and subsequent particle lattice formation is inhibited. The presence of sample drug diminishes the increasing absorbance in proportion to the concentration of drug in the sample. Sample drug content is determined relative to the value obtained for a known cutoff concentration of drug.

The provided document is a 510(k) summary for the Roche ONLINE DAT Propoxyphene Plus assay, not a study report. Therefore, it does not contain detailed information about specific studies, acceptance criteria, or performance data in the format typically found in a study.

However, based on the information provided, I can infer some aspects and highlight what is missing.

Here's an attempt to answer your questions by extracting what's available and noting what's explicitly absent:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in a quantitative table or provide detailed performance metrics like sensitivity, specificity, accuracy, or correlation coefficients. It primarily focuses on demonstrating substantial equivalence to a predicate device.

What is mentioned:
The assay is for the qualitative and semi-quantitative detection of propoxyphene and its metabolites in human urine on automated clinical chemistry analyzers at a cutoff of 300 ng/ml. This cutoff would be a key parameter for any performance evaluation.

2. Sample size used for the test set and the data provenance

• Sample size: Not specified in the 510(k) summary.
• Data provenance: Not specified. It's likely involved a combination of spiked samples and potentially clinical urine specimens, but the origin (e.g., country, retrospective/prospective) is not disclosed.

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

• This information is not provided. The ground truth for drug assays typically involves analytical methods (like GC/MS) rather than expert interpretation of results, so "experts" in the sense of clinicians reading images would not be applicable.

4. Adjudication method for the test set

• Not applicable as the ground truth for drug assays relies on objective analytical methods.

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 an in vitro diagnostic assay, not an AI-assisted diagnostic tool that involves human readers interpreting images. Therefore, an MRMC study is not relevant.

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

• Yes, effectively. The device itself is a standalone analytical system. Its performance is evaluated based on its ability to correctly identify the presence or absence of propoxyphene in urine samples relative to a gold standard analytical method. There is no human "in the loop" for the primary function of the assay.

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

• Analytical Gold Standard: For drug assays like this, the ground truth is typically established by a highly specific and sensitive reference method, such as Gas Chromatography/Mass Spectrometry (GC/MS). The "Indications for Use" section explicitly states: "Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method."

8. The sample size for the training set

• Not specified. The development of an immunoassay like this would involve extensive research and development; however, the term "training set" in the context of machine learning is not directly applicable here. The assay is "trained" in the sense that its components (antibodies, microparticles) are optimized, but this isn't data-driven training in the modern AI sense.

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

• Not applicable in the context of "training set" as understood today for AI. The "ground truth" for optimizing the assay components during development would have been based on known concentrations of propoxyphene and its metabolites, verified by analytical methods like GC/MS.

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ACON PPX One Step Propoxyphene Test Strip or ACON PPX One Step Propoxyphenc Test Device is a lateral flow chromatographic immunoassay test for the qualitative detection of Dpropoxyphene in human urine at a cut-off concentration of 300 ng/mL. It is a prescription assay intended for use by healthcare professionals including those at the point of care sites.

This assay provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical 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 used.

The ACON PPX One Step Propoxyphene Test Strip and ACON PPX One Step Propoxyphene Test Device are competitive binding, lateral flow immunochromatographic assays for the qualitative screening of Propoxyphene in a urine sample. The test is based on the principle of antibody immunochemistry. It utilizes the mouse monoclonal antibody to selectively detect elevated levels of Propoxyphene and its metabolite in urine at a cutoff concentration of 300 ng/mL. These tests can be performed without the use of an instrument.

A drug-positive urine specimen will not generate a colored-line in the designated test region, while a negative urine specimen or a urine specimen containing Propoxyphene at the concentration below the cutoff level will generate a colored-line in the test region. To serve as a procedural control, a coloredline should always appear at the control region, indicating that proper volume of specimen has been added and membrane wicking has occurred.

Acceptance Criteria and Study for ACON PPX One Step Propoxyphene Test Strip/Device

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state pre-defined acceptance criteria with numerical targets. Instead, it demonstrates "substantial equivalency" to an FDA-cleared predicate device. The performance is reported in terms of agreement with both the predicate device and Gas Chromatography/Mass Spectrometry (GC/MS).

Note: The confidence intervals provided (e.g., 98% - 99%) are described as "97.5% confidence interval" in the document, which might be a typo for a standard 95% CI. However, without further clarification, it's presented as stated. The ">99%" indicates that the observed agreement was 100%.

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

• Sample Size: 314 clinical urine specimens.
  • Approximately 10% of these specimens contained Propoxyphene concentrations between -25% and +25% of the 300 ng/mL cutoff.
  • The agreement calculations (positive, negative, overall) were based on 157 positive and 157 negative results, summing to 314.
• Data Provenance: The document states "clinical urine specimens," implying human-derived samples. However, the country of origin and whether the data was retrospective or prospective are not specified.

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

This type of diagnostic device (immunochromatographic assay for drug detection) typically does not rely on human "experts" in the traditional sense (e.g., radiologists interpreting images) for establishing ground truth in clinical validation. Instead, the ground truth for chemical analytes is established by a reference method.

• The ground truth in this study was primarily established by Gas Chromatography/Mass Spectrometry (GC/MS) analysis, which is considered the "gold standard" for confirmatory drug testing.
• The study also compared the device performance against "a FDA-cleared Propoxyphene test," which can be considered a strong predicate for comparison.
• Therefore, there were no human experts involved in establishing the ground truth, but rather analytical instruments and methodologies.

4. Adjudication Method for the Test Set

Since the ground truth was established by an objective analytical method (GC/MS), an adjudication method (like 2+1, 3+1 consensus among human readers) is not applicable in this context. The GC/MS results are considered definitive.

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

No. A MRMC comparative effectiveness study, which typically evaluates the performance of human readers with and without AI assistance, was not performed. This is a standalone diagnostic device that does not involve human interpretation in the same way imaging AI models do.

6. Standalone Performance Study

Yes. The described accuracy study conducted against GC/MS analysis serves as a standalone performance evaluation of the ACON PPX One Step Propoxyphene Test Strip and Device. The results indicate the device's ability to qualitatively detect Propoxyphene in urine.

7. Type of Ground Truth Used

The primary ground truth used was Gas Chromatography/Mass Spectrometry (GC/MS) analysis. The study also utilized comparison to an "FDA-cleared Propoxyphene test" as part of its validation.

8. Sample Size for the Training Set

The document is a 510(k) summary for a rapid immunochromatographic assay. This type of device does not typically involve a "training set" in the context of machine learning or AI models. The device's mechanism is based on established immunochemistry principles and monoclonal antibodies. Therefore, a training set sample size is not applicable or reported for this device.

9. How Ground Truth for the Training Set Was Established

As mentioned above, this device does not utilize a training set in the AI/machine learning sense. Therefore, the method for establishing ground truth for a training set is not applicable. The underlying principles (antibody sensitivity/specificity) are developed and optimized during the research and development phase of the assay, not through a "training set" of clinical data.

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'Rapid One'-Propoxyphene Test is a one-step lateral flow immunoassay for the qualitative detection of 300 ng/ml of propoxyphene and norpropoxyphene in human urine.

'Rapid One'-Propoxyphene Test is intended for professional use. It is not intended for over-the-counter sales to nonprofessionals. The assay to perform, but should not be used without proper supervision. This immunoassay is a simplified, qualitative screening method that provides only a preliminary result for use in determining the need for additional or confirmatory testing, i.e. gas chromatography/mass spectrometry (GC/MS.)

'Rapid One'-Propoxyphene Test provides only a preliminary analytical result. A more specific alternate chemical method must be used in order to obtain a more confirmed result. GC/MS is the preferred confirmatory method. Clinical and professional judgment should be applied to any drug of abuse test result. Particularly when preliminary results are used.

The assay employed in the 'Rapid One'-Propoxyphene Test is based on the same principle of highly specific reactions between antigens and antibodies.

This assay is a one-step, competitive, immunoassay for the detection of propoxyphene and its metabolite norpropoxyphene in human urine. The test device consists of a membrane strip onto which a drug conjugate has been immobilized and a colloidal goldmulti-antibody complex is dried at one end of the membrane. In the absence of any drug in the urine sample, the colloidal gold-antibody complex moves with the urine by capillary action to contact the immobilized drug conjugates. Antibody-antigen reactions occur forming visible lines in the 'test' area.

When drug is present in the urine sample, the drug or metabolite will compete with its corresponding drug conjugate in the test area for the limited antibody sites on the colloidal gold-labeled antibody complex. If sufficient amount of drug is present, it will fill all of the available antibody binding sites, thus preventing attachment of the labeled antibody to the drug conjugate. An absence of a color band (line) in the 'test' area is indicative of a positive result.

A control band (line), comprised of a different antibody/antigen reaction, is present on the membrane strip. The control line is not influenced by the presence or absence of drug in the urine, and therefore, should be present on all reactions.

A negative urine will produce two colored bands, and a positive sample will produce only one band.

Here's an analysis of the provided text, focusing on the acceptance criteria and the study details:

Device Name: 'Rapid One'-Propoxyphene Test

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" in terms of specific performance targets (e.g., sensitivity, specificity, accuracy percentages) that the device must meet. Instead, it describes the expected performance and successful reproducibility.

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

• Sample Size for Test Set: The document states: "Each sample was tested four times, twice daily, for five days." It also mentions "control urines containing concentrations above and below the stated cut-off" and "Negative controls." However, the total number of distinct samples (e.g., individual patient urine samples) used for the reproducibility study is not specified.
• Data Provenance: The document does not explicitly state the country of origin. It can be inferred that the testing was performed in a controlled laboratory setting. The data is prospective as it involves the preparation and testing of control urines for the study.

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

• Number of Experts: Not applicable, as the ground truth was established by analytical methods, not expert interpretation.
• Qualifications of Experts: N/A.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The ground truth (drug concentration) was objectively verified by GC/MS (Gas Chromatography/Mass Spectrometry), which is a gold-standard analytical method for drug confirmation. There was no mention of human adjudication.

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

• MRMC Study: No, a multi-reader multi-case comparative effectiveness study was not conducted or described. This type of study is typical for imaging devices where human interpretation is a primary component. The 'Rapid One'-Propoxyphene Test is an in vitro diagnostic immunoassay with a direct visual output, not requiring human interpretation of complex images or data in the same way.

6. Standalone (Algorithm Only) Performance

• Standalone Performance: Yes, the described performance relates to the device itself performing the test and producing results. The statement "The results confirmed the reproducibility of the ‘Rapid One’-Propoxyphene Test performance" explicitly refers to the device's ability to provide consistent outputs. This is a standalone performance assessment in that it's the test kit's output without human influence on the result generation, though human observation is needed to visually read the bands.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth for the test samples (drug concentrations) was established by GC/MS (Gas Chromatography/Mass Spectrometry). This is a highly accurate and confirmatory analytical method for drug detection and quantification. The document states: "All concentrations were verified by GC/MS."

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This device is an immunoassay kit, not a machine learning or AI-based algorithm that requires a separate "training set." The performance is inherent to the chemical and biological components of the test.

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

• How Ground Truth for Training Set Was Established: Not applicable, as there is no training set mentioned for this type of medical device.

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The Propoxyphene Enzyme Immunoassay is a homogeneous enzyme immunoassay with a 300 ng/mL cutoff. The assay is intended for use in the qualitative and semi-quantitative analyses of propoxyphene in human urine. The assay is designed for professional use with a number of automated clinical chemistry analyzers.

The Propoxyphene Enzyme Immunoassay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgement should be applied to any drug-ofabuse test result, particularly when preliminary positive results are used.

LZI's Propoxyphene Enzyme Immunoassay is a ready-to-use, liquid reagent, homogeneous enzyme immunoassay. The assay uses specific antibody that can detect propoxyphene in human urine with minimal cross-reactivity to various, common prescription drugs and abused drugs.

The assay is based on competition between propoxyphene labeled with glucose-6-phosphate dehydrogenase (G6PDH) enzyme, and free drug from the urine sample for a fixed amount of specific antibody. In the absence of free drug from the urine sample the specific antibody binds to the drug labeled with G6PDH enzyme causing a decrease in enzyme activity. The G6PDH enzyme activity is determined spectrophotometrically at 340 nm by measuring its ability to convert nicotinamide adenine dinucleotide (NAD) to NADH.

The provided text is a 510(k) summary for the Lin-Zhi International, Inc.'s Propoxyphene Enzyme Immunoassay. It describes the device, its intended use, and a comparison to a predicate device, along with performance characteristics. However, it does not provide detailed acceptance criteria in the typical format of a threshold that needs to be met (e.g., "sensitivity must be >90%"). Instead, it presents performance data for the new device alongside information from the predicate device (or states "No data available" for the predicate). The "acceptance criteria" are implied by the comparison to the predicate device and the conclusion that results were "acceptable."

Therefore, the table below reflects what can be extracted. Points 2 through 9 of your request cannot be fully answered from this document because it describes an in vitro diagnostic (IVD) assay, not a medical device that undergoes a typical "study" with a "test set" and "ground truth established by experts" in the way one might evaluate an AI/imaging device. The performance characteristics for IVD assays primarily focus on analytical performance like precision, sensitivity, accuracy against a reference method (like GC/MS), and specificity (cross-reactivity).

Acceptance Criteria and Device Performance

Study Details (as inferable from the document for this IVD device):

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

   • Accuracy (Qualitative): 57 positive samples were confirmed by GC/MS. The total number of samples compared against a commercial EIA was 126.
   • Provenance: Not explicitly stated, but typically clinical laboratory samples. No country of origin specified. Retrospective/Prospective not specified, but likely retrospective testing of banked samples or samples collected for validation.
   • Precision and Analytical Recovery: Not specified but typically involves multiple replicates of spiked samples and controls.

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

   • Not applicable in the typical sense for this IVD device. The "ground truth" for chemical analysis like this is established by a reference method.
   • Reference Method for Accuracy: Gas Chromatography/Mass Spectrometry (GC/MS) is cited as the preferred confirmatory method and was used for a portion of the accuracy study. GC/MS is an analytical chemistry technique, not an expert review.

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

   • Not applicable. The "ground truth" is determined by a definitive analytical method (GC/MS).

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • Not applicable. This is an in vitro diagnostic assay for drug detection, not an imaging or AI-driven diagnostic device that involves human readers/interpreters.

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

   • This is a standalone assay (chemical test), not an algorithm. Its performance is determined by the chemical reactions and spectrophotometric measurements. There is no "human-in-the-loop" performance component beyond interpreting the assay's final quantitative or qualitative result, which is common for all lab tests. The device itself performs the analysis without human interpretation of raw data beyond reading the instrument output.

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

   • The primary ground truth for accuracy was established using a reference analytical method, specifically Gas Chromatography/Mass Spectrometry (GC/MS).

7. The sample size for the training set:

   • Not applicable. As a chemical immunoassay, there is no "training set" in the machine learning sense. The assay is developed based on chemical principles and optimized through reagent formulation and calibration.

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

   • Not applicable. No "training set" in the machine learning sense. The assay's performance characteristics are inherent to its chemical design. Calibration would have used known concentration standards.

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The Instant-View™ Propoxyphene (PPX) Urine Test is a rapid one-step immunoassay intended for use in the qualitative detection of propoxyphene in human urine at a cutoff concentration of 300 ng/ml. It is for health care professional use only.

This test provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical 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 used.

Not Found

The provided text is an FDA 510(k) clearance letter for the Instant-View™ Propoxyphene (PPX) Urine Test. It does not contain detailed information about the acceptance criteria or the specific study that proves the device meets those criteria. The letter primarily confirms that the device has been found substantially equivalent to a legally marketed predicate device.

Therefore, I cannot provide the requested information based on the given text. The document does not include:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test or training sets, nor data provenance.
• Details about experts, adjudication methods, or ground truth establishment.
• Information on MRMC studies or standalone algorithm performance.

The document states the "Indications For Use" and mentions a cutoff concentration of 300 ng/ml for qualitative detection of propoxyphene in human urine, but it does not elaborate on the specific performance metrics or studies used to validate this.

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VERDICT® II PROPOXYPHENE is a one-step immunochromatographic test for the rapid, qualitative detection of propoxyphene and its metabolite, norpropoxyphene, in human urine. The test detects the major urinary metabolite of propoxyphene (norpropoxyphene) at 300 ng/mL. It is not for over-the-counter sale. VERDICT®-II PROPOXYPHENE PROVIDES ONLY A PRELIMINARY ANALYTICAL TEST RESULT. A MORE SPECIFIC ALTERNATE CHEMICAL METHOD MUST BE USED IN ORDER TO OBTAIN A CONFIRMED ANALYTICAL 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 OBTAINED.

VERDICT®-II PROPOXYPHENE is a one-step immunochromatographic test.

1. Acceptance Criteria and Reported Device Performance

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

The provided document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the data).

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

The document does not provide information on the number of experts used to establish ground truth or their qualifications.

4. Adjudication Method for the Test Set

The adjudication method is not mentioned in the provided document.

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

No information regarding a multi-reader multi-case (MRMC) comparative effectiveness study, nor any effect size of human reader improvement with AI assistance, is provided in the document. This is an in vitro diagnostic device, and such studies are typically not performed for this type of product.

6. Standalone Performance (Algorithm Only)

The device, VERDICT®-II PROPOXYPHENE, is described as a "one-step immunochromatographic test." This indicates it's a physical test kit, not an algorithm, and therefore the concept of standalone (algorithm-only) performance does not apply. The document does state that the test provides "only a preliminary analytical test result" and that "a more specific alternate chemical method must be used in order to obtain a confirmed analytical result" (e.g., GC/MS). This implies the device's performance is as a screening tool, not a definitive standalone diagnostic.

7. Type of Ground Truth Used

The document explicitly states that the device provides "only a preliminary analytical test result" and that "a more specific alternate chemical method must be used in order to obtain a confirmed analytical result. GAS CHROMATOGRAPHY/ MASS SPECTROMETRY (GC/MS) IS THE PREFERRED CONFIRMATORY METHOD." This indicates that the ground truth for validating the device's performance would be established by a "gold standard" confirmatory method like GC/MS.

8. Sample Size for the Training Set

The document does not specify the sample size used for the training set.

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

The document focuses on the device's indications for use and substantial equivalence to a predicate device. It does not detail the specific methodology for establishing ground truth for any training set. However, given the nature of the device (a rapid screening test for drug detection) and the mention of GC/MS as a confirmatory method, it's highly probable that samples with known concentrations of propoxyphene and norpropoxyphene (likely confirmed by methods like GC/MS) would be used to develop and validate such a test.

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