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The Visualine® Methadone DipStrip Test is used for qualitative testing for the presence of Methadone in human urine samples at or above 300 ng/ml. This test provides only a preliminary screening result; a more specific alternative method should be used to confirm the test result. This test is intended for use by medical professionals.

The Visualine® Methadone DipStripTest is based on the principle of antigen-antibody complexation and is used for the analysis of Methadone and it's metabolites in urine samples. The assay utilizes a competitive immunochromatographic technique involving a sample of test urine delivered in a sample well on the device that holds the porous membrane. When the drug is present in the urine test sample, the drug or drug metabolite competes for the limited antibody sites on the colored microspheres. When an adequate amount of drug is present, it will fill the limited antibody binding sites. This will prevent attachment of the colored microspheres to the probe site on the membrane. Therefore, a positive urine sample will inhibit the formation of precipitin at the probe site. A reference or control line with a secondary antibody reaction is added to the membrane strip to indicate viability of the test. This control line should always be present. A negative urine sample will produce two colored lines and a positive urine sample will show only one, the control line.

The Visualine® Methadone DipStripTest is an in-vitro immunoassay test by visual color comparison for the detection of Methadone and its metabolites in human urine samples, intended for professional use only.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set:
  • For Correlation Studies: 132 urine samples (56 positive, 76 negative based on Hitachi EmitII® Methadone Assay).
  • For Analytical Sensitivity (360 ng/ml Methadone): The exact number of samples tested at 360 ng/ml isn't explicitly stated as a distinct sample size for that specific concentration, but the >99% performance suggests a sufficient number were used. It's likely a subset or part of a larger panel of samples tested to establish sensitivity.
• Data Provenance: The samples were "provided by The Lab, Inc." and the correlation studies were "conducted at Sun Biomedical Laboratories". The origin of the samples (e.g., country, specific types of patients) is not specified. It is a retrospective analysis as it used existing samples.

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

The ground truth for the test set was not established by human experts in a traditional sense. Instead, the Hitachi EmitII® Methadone Assay with a cutoff at or above 300 ng/ml Methadone was used as the reference method (the "gold standard" or ground truth comparator). Therefore, no human experts with specific qualifications were involved in establishing the ground truth for these correlation studies.

4. Adjudication Method for the Test Set

Since the Hitachi EmitII® Methadone Assay served as the reference method, there was no human adjudication process involved for the test results of the Visualine® Methadone DipStrip Test. The results of the DipStrip Test were simply compared directly against the results of the Hitachi assay.

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

No, an MRMC comparative effectiveness study was not explicitly mentioned or performed as part of this submission. The study focuses purely on the standalone performance of the Visualine® Methadone DipStrip Test against a predicate device. This is a comparison of two analytical test systems, not a reader-based study.

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

Yes, the studies presented are standalone performance studies of the Visualine® Methadone DipStrip Test. The performance characteristics (sensitivity, specificity, efficiency, precision, stability) are intrinsic to the device itself when interpreted visually. While human interpretation of the visual color lines is part of the test's operation, the "standalone" context here refers to evaluating the device's accuracy compared to a reference method, rather than evaluating human readers using the device and comparing them to human readers without the device.

7. The Type of Ground Truth Used

The primary ground truth used was the results from the Hitachi EmitII® Methadone Assay, which is a homogenous enzyme immunoassay. This served as the reference method for determining the true positive or true negative status of the urine samples for methadone.

8. The Sample Size for the Training Set

The document does not explicitly mention a distinct "training set" or its sample size. Immunoassay devices typically do not undergo a training phase in the same way machine learning algorithms do. Development of such devices involves extensive R&D and optimization (which could be considered analogous to "training"), but specific sample sizes for this internal development are not usually disclosed in 510(k) summaries, nor is there a formal "training set" in the context of clinical validation as with AI models. The samples mentioned (132 for correlation) are for performance validation.

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

As no explicit training set is described in the provided document, the method for establishing its ground truth is also not applicable or not specified. The focus of the 510(k) summary is on demonstrating performance against predicate devices using a validation set.

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The Visualine®Cup VI for Drugs of Abuse Test is used for qualitative testing for the presence of Cocaine and it's metabolites at or above 300 ng/ml, Cannabinoids and it's metabolites at or above 50 ng/ml, Morphine and it's metabolites at or above 300 ng/ml, Methamphetamine at or above 1,000 ng/ml, Amphetamine at or above 1,000 ng/ml, Phencyclidine at or above 25 ng/ml, and Benzodiazepines and it's metabolites at or above 300 ng/ml in human urine samples. This test provides only a preliminary screening result; a more specific alternative method should be used to confirm the test result.

The Visualine® CupVI for Drugs of Abuse Test is based on the principle of antigen-antibody complexation and is used for the analysis of Cocaine, Cannabinoids, Morphine, Methamphetamine or Amphetamines, Phencyclidine, and Benzodiazepines and their corresponding metabolites in human urine samples. The assay utilizes a competitive immunochromatographic technique involving a sample of test urine delivered through a wicking action as the test panel (holding the porous membrane) is dipped into the urine sample. The drug in the sample competes for the limited antibody sites on the colored microspheres. When an adequate amount of drug is present, it will fill the limited antibody binding sites. This will prevent attachment of the colored microspheres to the probe site on the membrane. Therefore, a positive urine sample will inhibit the formation of precipitin at the probe site.

A reference or control line with a secondary antibody reaction is added to the membrane strip to check for proper sample migration on the membrane. This control line should always be present. A negative urine sample will produce two colored lines and a positive urine sample will show only one, the control line.

Here's a breakdown of the acceptance criteria and study information for the Visualine® Cup VI for Drugs of Abuse Test, based on the provided text:

Acceptance Criteria and Device Performance

Precision Acceptance Criteria:

• Within run and run to run: >99%
• Within day and day to day: >99%
• Within lot and lot to lot: >99%

Stability Acceptance Criteria:

• A urine specimen containing 0 ng/ml of the analyte of interest will render two distinct magenta lines (one test line and one control line).
• Samples containing +25% of cutoff analyte levels will show positive results >99% of the time, therefore yielding only the control line.

Study Information

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

   • Sample Size: 424 specimens for each drug category.
   • Data Provenance: Presumptive positive samples were provided by Redwood Toxicology Laboratory (Santa Rosa, California). Negative samples consisted of UTAK Laboratories Drug Free Urine pool #5488 and in-house negative urines. The study was conducted at Redwood Toxicology Laboratory and Sun Biomedical Laboratories. This indicates a mix of external and internal data, likely retrospective as existing samples were used.

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

   • The document does not specify the number or qualifications of experts used to establish ground truth. It states that presumptive positive samples were "assayed on the Hitachi at Redwood." This implies a laboratory instrument provided the reference standard, rather than human experts interpreting the results for ground truth.

3. Adjudication method for the test set:

   • Not applicable. The ground truth was established by laboratory instrument (Hitachi), not through human interpretation requiring adjudication.

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

   • No MRMC comparative effectiveness study was done. This device is an in-vitro diagnostic test for direct visual interpretation (presence/absence of lines) and does not involve AI or human reader interpretation in the context of diagnostic imaging or similar fields where MRMC studies are typical. The comparison was between the new device and existing reference devices.

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

   • The performance data presented is for the standalone performance of the Visualine® Cup VI test. It's a qualitative immunoassay that produces a visual result directly. There isn't an "algorithm" in the typical AI sense; the test itself is the "device" being evaluated for its direct output. The user simply interprets the visual lines.

6. The type of ground truth used:

   • Laboratory Instrument Reference Standard: The ground truth for positive samples was established by assaying them on a Hitachi instrument. For negative samples, known drug-free urine pools (UTAK Laboratories Drug Free Urine pool #5488) and in-house negative urines were used. This is a laboratory-based, objective reference standard.

7. The sample size for the training set:

   • The document does not explicitly mention a "training set" in the context of machine learning or AI. This device is a biochemical immunoassay, not an algorithmic device that requires a distinct training phase with a dataset. The development and optimization of the immunoassay itself would have involved internal validation and formulation studies, but these are not described as a "training set" in the common sense.

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

   • As there's no explicit "training set" described for an AI/ML model, this question is not applicable. The development of the immunoassay (e.g., antibody selection, membrane formulation) would have been based on established chemical and biological principles and internal validation, rather than a "ground truth" derived from a specific dataset in the way an AI model is trained.

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The Visualine®II (SunLine®) Barbiturates Test is used for qualitative testing for the presence of Secobarbital in urine samples at or above 300 ng/ml. This test provides only a preliminary screening result; a more specific alternative method should be used to confirm the test result. This test is intended for use by medical professionals.

Not Found

The provided text is a 510(k) premarket notification approval letter for the Visualine® II (SunLine®) Barbiturates Test. It confirms that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain the detailed study information required to answer your specific questions about acceptance criteria and device performance studies.

The letter indicates the device's intended use: "qualitative testing for the presence of Secobarbital in urine samples at or above 300 ng/ml." It also states that the test provides a preliminary screening result and recommends a more specific alternative method for confirmation.

To address your questions directly, information regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and comparative effectiveness studies would typically be found in the 510(k) submission document itself or associated clinical study reports, which are not part of this approval letter.

Therefore, I cannot provide the requested table and study details based solely on the provided text. The document is an FDA approval letter, not the technical study data.

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The Visualine® Barbiturates DipStrip Test is used for qualitative testing for the presence of Secobarbital in urine samples at or above 300 ng/ml. This test provides only a preliminary screening result; a more specific alternative method should be used to confirm the test result. This test is intended for use by medical professionals.

The Visualine® Barbiturates DipStripTest is based on the principle of antigen-antibody complexation and is used for the analysis of Barbiturates and it's metabolites in urine samples. The assay utilizes a competitive immunochromatographic technique involving a sample of test urine delivered in a sample well on the device that holds the porous membrane. When the drug is present in the urine test sample, the drug or drug metabolite competes for the limited antibody sites on the colored microspheres. When an adequate amount of drug is present, it will fill the limited antibody binding sites. This will prevent attachment of the colored microspheres to the probe site on the membrane. Therefore, a positive urine sample will inhibit the formation of precipitin at the probe site. A reference or control line with a secondary antibody reaction is added to the membrane strip to indicate viability of the test. This control line should always be present. A negative urine sample will produce two colored lines and a positive urine sample will show only one, the control line.

Here's a breakdown of the acceptance criteria and study details for the Visualine® Barbiturates DipStrip Test, based on the provided document:

Acceptance Criteria and Device Performance

Study Details

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

   • Sample Size: 201 urine samples (190 correctly identified + 11 misidentified = 201 total). Specifically, 101 samples were positive and 100 were negative according to the predicate device.
   • Data Provenance: The samples were "provided by The Lab, Inc." The country of origin is not explicitly stated, but the manufacturer (Sun Biomedical Laboratories, Inc.) is located in Blackwood, NJ, USA, and FDA approval is being sought, suggesting a US context for the study. The study appears to be retrospective, using a collected set of samples.

2. 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. The "ground truth" for correlation was established by comparison to results from the Hitachi Emit® Barbiturates Assay, which is a laboratory-based homogenous enzyme immunoassay. The document does not describe human expert involvement in establishing ground truth for the test set.

3. Adjudication method for the test set:

   • None specified. The comparison is directly against the results of the Hitachi Emit® Barbiturates Assay.

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

   • Not applicable. This device is an in-vitro diagnostic dipstrip test for visual color comparison, not an AI-assisted diagnostic tool for human readers. No MRMC study or AI assistance is mentioned.

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

   • Yes, effectively. The reported performance (sensitivity, specificity, efficiency) is for the Visualine® Barbiturates DipStrip Test itself, in comparison to the Hitachi Emit® Barbiturates Assay. Although the dipstrip test is read visually, the reported performance metrics reflect the device's ability to produce its result (presence/absence of a line) accurately relative to a reference method, without specifying human variability in reading. The intent of the device is for professional use, implying trained personnel will interpret the visual results.

6. The type of ground truth used:

   • Reference Method Comparison. The ground truth was established by the results obtained from the Hitachi Emit® Barbiturates Assay, which itself is a commercially available and presumably validated laboratory immunoassay.

7. The sample size for the training set:

   • The document does not provide information about a separate "training set" for the Visualine® Barbiturates DipStrip Test. This type of immunoassay typically undergoes development and optimization, rather than a machine learning-style training process with a distinct training set. The correlation studies mentioned are evaluation studies.

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

   • As there is no mention of a separate training set, this information is not applicable/not provided. The development of the immunochromatographic test would involve internal validation and optimization against known samples (spiked samples, characterized clinical samples), but these are not formally described as a "training set" with ground truth established in the same way a machine learning algorithm would.

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Simultaneous qualitative visual tests for five (5) drugs of abuse: Cocaine, Morphine, Cannabinoids, Methamphetamine and Phencyclidine and their metabolites in urine sample.

The Visualine® V Drugs of Abuse Dipstrip Panel test is based on the principle of antigen-antibody complexation and is used for the analysis of Cocaine, Cannabinoids, Morphine, Methamphetamine, and Phencyclidine and their corresponding metabolites in human urine samples. The assay utilizes a competitive immunochromatographic technique involving a sample of test urine delivered through a wicking action as the panel (holding the porous membrane) is dipped into the urine sample. The drug in the sample compeics for the limited antibody sites on the colored microspheres. When an adequate amount of drug is present, it will fill the limited antibody binding sites. This will prevent attachment of the colored microspheres to the probe site on the membrane. Therefore, a positive urine sample will inhibit the formation of precipitin at the probe site.

The information discusses the Visualine®V Drugs of Abuse Dipstrip Panel for qualitative determination of several drugs and their metabolites in human urine.

Here's an analysis of the provided text to fulfill your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" as a target value set before the study. Instead, it presents the results of a correlation study with a legally marketed predicate device (Hitachi 717) as evidence of performance. The performance metrics presented are Sensitivity, Specificity, and Efficiency.

Reproducibility (Precision) studies also reported:

• Within run and run to run: > 99 %
• Within day and day to day: > 99 %
• Within lot and lot to lot: > 99 %

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

The test set consisted of:

• Presumptive positive samples: 50 for each drug (Cocaine, Cannabinoids, Morphine, Methamphetamine, Phencyclidine). These were initially tested on the Hitachi 717.
• Negative samples:
  • Cocaine: 247
  • Cannabinoids: 253
  • Morphine: 257
  • Methamphetamine: 255
  • Phencyclidine: 255
    These negative samples came from UTAK Laboratories Drug Free Urine pool, Lot# 2647, and in-house negative urines (tested with Sun Biomedical's Visualine® II product).

Data Provenance: The correlation studies were conducted at Redwood Toxicology Laboratory, Santa Rosa, California, and Sun Biomedical Laboratories. The samples used were a mix of presumptive positive samples provided by Redwood (implying patient samples) and defined negative urine pools. This suggests a retrospective collection of samples for the positive cases and a controlled source for the negative cases. The country of origin is implicitly the USA (California).

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

The document does not mention the number or qualifications of experts used to establish a ground truth.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method with multiple readers. The "ground truth" for the correlation study relies on the results from the Hitachi 717 instrument using Diagnostic Reagents, Inc. material, which is treated as the reference method.

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

This is not applicable. The device is a "Dipstrip Panel" presenting a visual color comparison. It is an in-vitro diagnostic device, not an AI-powered image analysis tool or decision support system that would involve human readers making interpretations of complex data with or without AI assistance. The performance is based on the device's ability to detect substances, not on human interpretation of its results changing with AI.

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

Yes, this was a standalone performance evaluation. The Visualine®V Dipstrip Panel is described as a "visual color precipitin formation" detection method. The study involved "blinded studies" where the Visualine®V panel results were compared to the reference Hitachi 717 results. This implies the dipstrip panel was read and its results were correlated directly with the established results without human intervention or interpretation that would alter the device's inherent performance.

7. The Type of Ground Truth Used

The ground truth used for the correlation study was based on the results from the Hitachi 717 instrument using Diagnostic Reagents, Inc. EIA (Enzyme Immunoassay) individual assays. This legally marketed predicate device served as the reference standard. For negative samples, established drug-free urine pools were used.

8. The Sample Size for the Training Set

The document does not specify a training set sample size. This is common for in-vitro diagnostic devices built on established chemical or immunological principles, where "training" in the machine learning sense is not applicable. The device's performance is determined by its design and chemical reactions, not by being "trained" on data.

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

As no training set is mentioned (see point 8), this question is not applicable. The device operates based on a competitive immunochromatographic technique.

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The Visualine® II Assay is used for qualitative testing for the presence of Phencyclidine in urine.

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I am sorry, but the provided text does not contain the detailed information necessary to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as requested. The document is a 510(k) clearance letter from the FDA for a device named "Visualine® II Phencyclidine (SunLine™ Phencyclidine)", indicating that it has been found substantially equivalent to a legally marketed predicate device.

Specifically, the document does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for the test set or data provenance details.
3. Number or qualifications of experts used for establishing ground truth.
4. Adjudication methods.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study, or effect size.
6. Details about a standalone algorithm performance study.
7. The type of ground truth used (e.g., pathology, outcomes data).
8. Sample size for the training set.
9. How the ground truth for the training set was established.

The letter primarily focuses on regulatory approval and classification, and refers to the "indications for use" without providing the underlying study data. The "Indications For Use" section states: "The Visualine® II Assay is used for qualitative testing for the presence of Phencyclidine in urine." This describes the device's function but not its performance metrics or the studies backing them.

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Qualitative visual test for the presence of Methadone and its metabolites in urine samples.

Visualine II (Also Known As SunLine) Methadone

I am sorry, but the provided text from the FDA 510(k) letter for the Visualine II (SunLine) Methadone device does not contain any information about acceptance criteria or a study proving that the device meets those criteria.

This document is a marketing clearance letter, which states that the FDA has reviewed the 510(k) submission and determined the device to be substantially equivalent to a legally marketed predicate device for the stated indications for use. It outlines regulatory classifications, general controls, and contact information for further inquiries.

To answer your request, I would need to analyze a different type of document, such as the actual 510(k) summary, a clinical study report, or a validation report, which would typically contain details about performance studies and acceptance criteria.

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Qualitative visual teit for the presence of Methliam phetamine and its metabolites in Uside sample

Not Found

This document is a 510(k) clearance letter from the FDA for a device called "Visualine® II Methamphetamine." It states that the device is substantially equivalent to a legally marketed predicate device.

Unfortunately, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications. This letter is a regulatory approval document, not a scientific study report.

Therefore, I cannot fulfill your request for the specific details outlined in your prompt based on the provided text. To answer your questions, I would need access to the actual 510(k) submission documentation, which would include the study data and performance claims.

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