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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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The Fastect® II PPX Drug Screen Dipstick Test is a lateral flow immunoassay for the rapid detection of propoxyphene in human urine at or above 300 ng/mL.

The Fastect® II Drug Screen Dipstick and QuickTox® Drug Screen Dipcard are lateral flow immunoassay for the rapid detection of multiple drugs and drug metabolites in human urine at or above the following cutoff concentration:

THC 11-nor-Δ9-Tetrahydrocannabinol-9-carboxylic acid 50 ng/ml
COC Benzoylecgonine 300 ng/ml
OPI Morphine 300 ng/ml
MET Methamphetamine 500 ng/ml
AMP Amphetamine 1000 ng/ml
PCP Phencyclidine 25 ng/ml
BZO Oxazepam 300 ng/ml
BAR Secobarbital 300 ng/ml
MTD Methadone 300 ng/ml
TCA Nortriptyline 1000 ng/ml
MDMA 3,4-methylenedioxymethamphetamine 500 ng/ml
OXY Oxycodone 100 ng/ml
BUP Buprenorphine 10 ng/ml
PPX Propoxyphene 300 ng/ml

These tests provide visual qualitative results and are intended for in vitro diagnostic use only. It is for prescription point-of-care use only and not intended for over-the-counter sale to non-professionals.

These tests provide only a preliminary test result. For a quantitative result or to confirm preliminary positive results obtained by the QuickTox® Drug Screen Dipcard, Fasted® II Drug Screen Dipstick or Fasted® II PPX Drug Screen Dipstick tests, a more specific alternative method such as Gas Chromatography/Mass Spectrometry (GC/MS) must be used. Clinical consideration and professional judgment should be applied to any drug of abuse test results, particularly when a preliminary positive result is indicated.

The Fastect® II Drug Screen Dipstick with Propoxyphene and QuickTox® Drug Screen Dipcard with Propoxyphene contain multiple drugs and drug metabolites in addition to Propoxyphene. Propoxyphene is added as a new analyte. The Fastect® II PPX Drug Screen Dipstick only contains the propoxyphene analyte. All dipstick and dipcard devices are based on the principle of highly specific immunochemical reactions between antigens and antibodies and all devices utilize a competitive immunoassay procedure in which an immobilized drug conjugate competes with the drug present in urine for limited antibody binding sites.

The Fastect® II PPX Drug Screen Dipstick, Fastect® II Drug Screen Dipstick and QuickTox® Drug Screen Dipcard devices are standardized to detect Propoxyphene in human urine at a cutoff concentration of 300 ng/ml. These tests can be performed without the use of any additional instruments.

A control band with a different antigen/antibody reaction is added to the immunochromatographic membrane strip and should always appear regardless of the presence of drug or metabolite. The appearance of the control band during testing indicates that the test has completed and the test is valid.

The provided document describes the Fastect® II PPX Drug Screen Dipstick, Fastect® II Drug Screen Dipstick, and QuickTox® Drug Screen Dipcard devices, which are lateral flow immunoassays for the qualitative detection of Propoxyphene (PPX) and other drugs in human urine at specified cutoff concentrations.

1. Table of Acceptance Criteria and Reported Device Performance (Focus on Propoxyphene as it's the new analyte):

The document does not explicitly state "acceptance criteria" through numerical thresholds for sensitivity, specificity, or accuracy in a traditional sense. Instead, the acceptance criterion for regulatory approval appears to be demonstrating substantial equivalency to a predicate device (ACON® multi-CLINTM Drug Screen Test Device K041685) for the detection of Propoxyphene at a 300 ng/ml cutoff. The "Performance Specifications" section outlines the types of analytical studies conducted to establish this equivalency.

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

The document lists the types of performance characteristic studies performed (Stability, Optimal Read Time, Precision, Method Comparison, Specificity and Interference, Effect of pH and Specific Gravity) but does not provide details on the sample sizes used for these test sets.

The data provenance (e.g., country of origin, retrospective or prospective) is not specified in this summary.

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

This information is not provided in the document. For drug screening tests like these, ground truth is typically established through a reference method (like GC/MS or LC/MS), not through a panel of experts interpreting results.

4. Adjudication Method for the Test Set:

This information is not applicable or provided. When a reference method like GC/MS is used to establish ground truth, there isn't typically an "adjudication method" involving multiple human readers interpreting the output of the reference method.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study evaluates the performance of human readers, sometimes with and without AI assistance. The described devices are in vitro diagnostic tests that provide a visual qualitative result, intended for direct use by a professional without a complex interpretation process that would typically involve multiple readers. The document highlights the need for confirmation by GC/MS or LC/MS for preliminary positive results, indicating that human interpretation of the dipstick is a preliminary step, not a diagnostic endpoint requiring complex reader studies.

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

Yes, the performance studies described are essentially standalone performance evaluations. The devices are immunochromatographic tests that yield a visual result (presence or absence of a line). The "performance characteristics studies" (Stability, Optimal Read Time, Precision, Method Comparison, Specificity and Interference, Effect of pH and Specific Gravity) evaluate the inherent analytical performance of the device itself, independent of human interpretation variability after the preliminary visual reading. The device's "algorithm" is the biochemical reaction and the visual readout mechanism.

7. The Type of Ground Truth Used:

The document states: "All preliminary positive test results obtained with these devices must be confirmed by another test method, preferably GC/MS or LC/MS confirmatory analysis." This strongly implies that Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Mass Spectrometry (LC/MS) would be the gold standard or "ground truth" used to validate the performance of these devices in a method comparison study. These are highly sensitive and specific analytical techniques for drug detection and quantification.

8. The Sample Size for the Training Set:

This information is not provided as these are not machine learning/AI devices in the traditional sense that require a "training set." The development of such immunoassay devices involves laboratory testing and optimization of reagents, antibodies, and manufacturing processes, rather than training on a dataset in the way an AI algorithm would be trained.

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

As these are not traditional AI devices with a "training set," this question is not directly applicable. The "ground truth" for optimizing the assay's performance during development would rely on known concentrations of propoxyphene and its metabolites, confirmed by highly accurate analytical methods like GC/MS or LC/MS.

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The EasyRA PPX reagent is intended for the qualitative and semi-quantitative measurement of Propoxyphene (PPX) in human urine, using MEDICA's EasyRA Chemistry Analyzer in clinical laboratories. The cut-off point of the assay is 300ng/ml, and provides only a preliminary analytical result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Mass Spectrometry (LC/MS) are the preferred confirmatory method. The semi-quantitative mode is intended to enable laboratories to determine the appropriate dilution of the specimen for confirmation by a reference method such as GC/MS or LC/MS and to allow laboratories to establish effective quality control procedures for the PPX assay.

Medica's Propoxyphene (PPX) Calibrators are intended for the calibration of the PPX Enzymatic Immunoassay to estimate propoxyphene in human urine, using Medica's PPX reagent on the EasyRA clinical chemistry analyzer.

Medica's Propoxyphene (PPX) QC Materials are intended for the validation of the PPX Enzymatic Immunoassay to estimate propoxyphene in human urine, using Medica's PPX reagent and PPX calibrator on the EasyRA clinical chemistry analyzer.

Not Found

This document is a 510(k) premarket notification decision letter from the FDA for in vitro diagnostic devices (IVDs) related to Propoxyphene (PPX) testing. It does not contain information about acceptance criteria or a study proving device performance as requested.

The document states that the FDA has reviewed the 510(k) and determined the device is substantially equivalent to legally marketed predicate devices. This means the device's performance is considered similar enough to existing devices, and a separate study demonstrating new acceptance criteria or performance against such criteria is not typically required in a 510(k) for substantial equivalence.

Therefore, I cannot provide the requested information from the given text because it is not present.

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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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The Propoxyphene assay is used for the qualitative analysis of propoxyphene in human urine with a cutoff of 300 ng/mL for used a clinical laboratories. Measurements obtained by this device are used in the diagnosis and treatment of propoxyphene use or overdose. The Propoxyphene assay is calibrated with propoxyphene and will detect propoxyphene and metabolites and analogs. The Propoxyphene assay provides only a preliminary analytical test result. A more specific alternate chemical method must be 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 results are used.

Propoxyphene is an in vitro diagnostic assay for the qualitative analysis of Propoxyphene in human urine. The assay is a homogeneous enzyme, immunoassay with a 300 ng/ml, cutoff. The assay is based on competition between drug in the specimen and drug labeled with the enzyme glucose-6-phosphate dehydrogenase (G6PDH) for antibody binding sites. Enzyme activity decreases upon binding to the antibody, so the drug concentration in the specimen can be measured in terms of enzyme activity. Active enzyme converts NAD to NADH, resulting in an absorbance change that can be measured spectrophotometrically.

The provided text describes the Propoxyphene assay, an in vitro diagnostic assay for the qualitative analysis of Propoxyphene in human urine. The study conducted aims to demonstrate its substantial equivalence to the Emit® II Propoxyphene assay (K923873).

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

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" for the Propoxyphene assay in a tabular format with numerical targets. Instead, it defines the performance characteristics and demonstrates substantial equivalence to a predicate device. The primary performance metric reported is concordance (agreement) with the predicate device.

Note on "Acceptance Criteria": For substantial equivalence claims, the acceptance criteria are often implicitly tied to demonstrating that the new device performs "as well as" or "similarly to" the predicate device for its intended use. Here, 99% agreement with the predicate device appears to be the key performance indicator used to support substantial equivalence.

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

• Sample Size for Test Set: Not explicitly stated as a single number for the comparative performance study. The text mentions "The clinical specimens tested ranged from 404 to 56,662 ng/mL," implying that multiple clinical specimens were used. However, the exact number tested for the 99% concordance is not provided.
• Data Provenance: Not specified (e.g., country of origin). The study used "clinical specimens." It is not stated whether the data was retrospective or prospective, but clinical specimens usually imply retrospective collection for such comparative studies.

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

• Number of Experts: Not applicable. For this type of in vitro diagnostic assay, the "ground truth" for the test set is established by a reference method, not by human experts.
• Qualifications of Experts: N/A.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The ground truth is established by a reference method (GC/MS for confirmatory analysis, and the predicate device for comparative performance), not by a consensus of experts. Discrepancies between the new device and the predicate device were resolved by GC/MS (e.g., the one discordant sample was confirmed by GC/MS).

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

• MRMC Study: No, this is an in vitro diagnostic device for analyte detection, not an imaging analysis or decision support system that involves human readers interpreting cases. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study is not relevant here.

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

• Standalone Performance: Yes, the device's performance characteristics (e.g., concordance, precision, cutoff, limit of detection) are reported for the instrument-based assay itself, operating without human interpretation of the primary result. The assay generates a qualitative result (positive/negative) based on spectrophotometric measurements. The phrase "qualitative analysis" refers to the output of the device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• Type of Ground Truth:
  • For the comparative study assessing agreement, the Emit® II Propoxyphene assay (predicate device) was used as a reference for initial comparison.
  • For resolving discrepancies and confirming concentrations, GC/MS (Gas Chromatography/Mass Spectrometry) was used, which is considered the "gold standard" confirmatory method for drug testing.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable/not provided. This document describes the performance of a developed assay for regulatory submission, not the development process involving a separate training set for a machine learning model. Immunoassays are not "trained" in the machine learning sense; rather, they are designed and optimized based on chemical and biological principles.

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

• Ground Truth for Training Set: Not applicable. As mentioned above, this is an immunoassay, not a machine learning model, so there isn't a "training set" with ground truth in the AI context. The assay's parameters would have been optimized through laboratory experimentation and validation, rather than learning from a labeled training dataset.

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