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The Amedica Drug Screen Test THC/COC/OPI/AMP/MET/PCP/MDMA/BAR/BZO/MTD/TCA/OXY is an in vitro diagnostic test for the rapid detection of the following drugs in human urine: THC, COC, OPI, AMP, MET, PCP, MDMA, BAR, BZO, MTD, TCA, OXY. This test is intended for use by over-the-counter (OTC) consumers as the first step in a two step process to provide consumers, including but not limited to concerned parents, with information concerning the presence or absence of the above stated drugs or their metabolites in a urine sample.

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The provided document is a 510(k) clearance letter from the FDA for a drug test cup (Amedica Drug Test Cup). It outlines the device's indications for use and lists the drugs it can detect along with their respective cut-off levels. However, this document does not contain the detailed study information, acceptance criteria, or performance data that would allow for a comprehensive answer to your request.

The letter states that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices. This implies that the device likely met certain performance standards in efficacy and safety to achieve this equivalence, but the specifics of those studies and their results are not present in this document.

Therefore, I cannot provide the requested information, which includes:

1. A table of acceptance criteria and the reported device performance: This document only lists the cutoff levels for each drug but does not specify performance metrics like sensitivity, specificity, accuracy, or acceptance criteria for these metrics.
2. Sample sizes, data provenance, number of experts for ground truth, adjudication method, MRMC study details, standalone performance, type of ground truth used, training set details: None of this information is available in the provided FDA clearance letter. This type of detail would typically be found in the 510(k) submission itself or in a separate study report, not in the clearance letter.

The letter focuses on the regulatory determination of substantial equivalence and outlines the general controls and regulations applicable to the device.

In summary, the provided document does not contain the specific study details needed to answer your request about acceptance criteria and device performance.

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The Amedica Home Drug Test Cup is an in vitro diagnostic test for the rapid detection of the following drugs in human urine.
Marijuana, Cocaine, Amphetamine, Methamphetamine, Opiates, Opiates300, Pencyclidine, Barbiturates, Benzodiazepines, Methadone, Oxycodone, MDMA, Tricyclic Antidepressants.
This test is intended for over-the-counter (OTC) consumer use as the first step in a two step process to provide consumers, including but not limited to concerned parents, with information concerning the presence or absence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing the second step in the process, is provided in the package labeling.

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The provided text is a 510(k) summary for the "Amedica Home Drug Test Cup," a device intended for over-the-counter (OTC) consumer use for detecting various drugs in human urine.

Acceptance Criteria and Device Performance:

The document does not explicitly state "acceptance criteria" in a table format with performance metrics. However, the core of the submission is to demonstrate substantial equivalence to legally marketed predicate devices, which implies that the performance of the Amedica Home Drug Test Cup is comparable to these predicates for the stated indications.

The key performance aspect mentioned is the detection of specific drugs at defined cutoff levels. The device is intended to provide a preliminary positive or negative result based on these cutoffs.

Note: The document only lists the cutoffs and states the device's purpose is to detect these drugs at these cutoffs. It does not provide specific sensitivity, specificity, or accuracy data for the Amedica Home Drug Test Cup. The substantial equivalence claim implies that its performance is equivalent to legally marketed predicate devices, meaning it meets the generally accepted performance standards for point-of-care drug tests.

Study Information:

The provided text does not contain any details about a specific study (like a clinical trial or performance evaluation study) that proves the device meets acceptance criteria. A 510(k) submission primarily relies on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting full clinical trial data as would be required for a PMA (Premarket Approval) application.

Therefore, the following information points cannot be directly extracted from the provided text:

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not mentioned.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not mentioned. The "ground truth" for these types of tests is typically established through a more specific alternate chemical method (like GC/MS or HPLC), not expert consensus in the diagnostic imaging sense.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not mentioned.
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 relevant or mentioned, as this is a device for drug detection and not an AI-assisted diagnostic imaging tool.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device itself is standalone in terms of generating a preliminary result. There's no "algorithm only" performance separate from the physical test cup.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The document specifies that for preliminary positive results, a "more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography / Mass Spectrometry (GC/MS) or High Performance Liquid Chromatography (HPLC) is the preferred confirmatory method." This indicates that GC/MS or HPLC are the established ground truth methods.
7. The sample size for the training set: Not mentioned. This type of device relies on chemical reactions, not machine learning or AI with training sets.
8. How the ground truth for the training set was established: Not applicable, as there's no training set in the AI/ML sense.

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The AmediCheck Drug Screen Test THC/COC/OPVAMP/MET/PCP/BAR/BZQ/MDMA/OXY/MTD/ PPX/TCA is an in vitro diagnostic test for the rapid detection of THC, benzoylecgonine, morphine, amphetamine, methamphetamine, phencyclidine, barbiturates, benzodiazepines, MDMA, oxycodone, methadone, propoxyphene and tricyclic antidepressants in human urine at the following cutoff concentration:

THC 11-nor-Δ9-Tetrahydrocannabinol-9-carboxylic 50 ng,ml
COC Benzoylecgonine 300 ng,ml
OPI Morphine 2000 ng,ml
OPI Morphine 300 ng,ml
AMP Amphetamine 1000 ng,ml
MET Methamphetamine 1000 ng,ml
PCP Phencyclidine 25 ng,ml
MDMA 3,4 methylenedioxymethamphetamine 500 ng/ml
BAR Secobarbital 300 ng/ml
BZO Oxazepam 300 ng/ml
MTD Methadone 300 ng/ml
TCA Nortriptyline 1000 ng/ml
PPX Propoxyphene 300 ng/ml
OXY Oxycodone 300 ng/ml

This test kit is used to obtain a visual, qualitative result and is intended for professional use. It is not intended for over the counter sale.

This assay provides only a preliminary result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometers (GCMS) 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.

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The provided text describes the AmediCheck Drug Screen Test, an in vitro diagnostic test for the rapid detection of various drugs in human urine. It also includes information regarding its FDA 510(k) clearance (K080872). However, the document does not contain specific information about the acceptance criteria and the study that proves the device meets those criteria in the format requested (e.g., sample sizes for test and training sets, expert qualifications, adjudication methods, details of comparative effectiveness studies, or standalone performance data).

The document is a clearance letter from the FDA stating that the device is substantially equivalent to legally marketed predicate devices. It outlines the drugs detected, their cut-off concentrations, and the intended use (professional, not over-the-counter, provides preliminary results, GC/MS for confirmation).

Therefore, I cannot populate most of the requested fields based on the provided text.

Here's what can be extracted and a clear indication of what is not present:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not explicitly stated in terms of performance metrics (e.g., sensitivity, specificity, accuracy thresholds). The document only lists the cutoff concentrations for each drug.

  Drug	Substance Detected	Cutoff Concentration
  THC	11-nor-Δ9-Tetrahydrocannabinol-9-carboxylic	50 ng/ml
  COC	Benzoylecgonine	300 ng/ml
  OPI	Morphine	2000 ng/ml
  OPI	Morphine	300 ng/ml
  AMP	Amphetamine	1000 ng/ml
  MET	Methamphetamine	1000 ng/ml
  PCP	Phencyclidine	25 ng/ml
  MDMA	3,4 methylenedioxymethamphetamine	500 ng/ml
  BAR	Secobarbital	300 ng/ml
  BZO	Oxazepam	300 ng/ml
  MTD	Methadone	300 ng/ml
  TCA	Nortriptyline	1000 ng/ml
  PPX	Propoxyphene	300 ng/ml
  OXY	Oxycodone	300 ng/ml

• Reported Device Performance: Not reported in the document (e.g., sensitivity, specificity, accuracy). The FDA letter indicates substantial equivalence, implying that its performance is comparable to its predicates, but specific data is not provided here.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not provided. This document is an FDA clearance letter, not the detailed study report itself.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable/Not provided. For drug screens, ground truth is typically established by definitive chemical methods (like GC/MS), not by expert consensus on visual interpretation for the test set itself. The document mentions "professional use" and that "Clinical consideration and professional judgment should be applied," but this refers to the interpretation of results, not the establishment of ground truth for device validation.

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

• Not applicable/Not provided. Adjudication methods are typically relevant for studies where multiple human readers interpret data, and their disagreements need resolution. This is less common for a chemical assay like a drug screen where definitive lab methods provide the ground truth for performance validation.

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

• Not applicable. This device is an in vitro diagnostic drug screen, not an AI-powered diagnostic imaging tool that requires human reader interpretation that could be augmented by AI.

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

• Not applicable. This is a rapid diagnostic test providing a visual, qualitative result. While the test itself operates "stand-alone" in terms of producing a result, its performance is evaluated against definitive chemical methods, not typically as an algorithm requiring separate 'standalone' vs. 'human-in-the-loop' analysis in the context of AI.

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

• The document implies that Gas chromatography/mass spectrometers (GC/MS) is the preferred confirmatory method for preliminary positive results. This strongly suggests that GC/MS would have been used as the ground truth for validating the device's performance.

8. The sample size for the training set

• Not provided. The document does not refer to a "training set" as this is not an AI/machine learning device. For assay development, there would be development samples, but those details are not in this FDA clearance.

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

• Not applicable/Not provided. As stated above, this is not an AI/machine learning device with a "training set" in that context.

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The Amedica Drug Screen Test Cup II THC, COC, OPI, AMP, MET, PCP, MDMA, BAR, BZO, MTD, TCA, PPX, OXY is an in vitro diagnostic test for the rapid detection of THC, benzoylecgonine, morphine, amphetamine, methamphetamine, phencyclidine, MDMA, barbiturates, benzodiazepines, methadone, tricyclic antidepressants, propoxyphene and oxycodone in human urine at the following cutoff concentration:

THC 11-nor-Δ9-Tetrahydrocannabinol-9-carboxylic 50 ng,ml
COC Benzoylecgonine 300 ng,ml
OPI Morphine 2000 ng,ml
OPI Morphine 300 ng,ml
AMP Amphetamine 1000 ng,ml
MET Methamphetamine 1000 ng,ml
PCP Phencyclidine 25 ng,ml
MDMA 3,4 methylenedioxymethamphetamine 500 ng/ml
BAR Secobarbital 300 ng/ml
BZO Oxazepam 300 ng/ml
MTD Methadone 300 ng/ml
TCA Nortriptyline 1000 ng/ml
PPX Propoxyphene 300 ng/ml
OXY Oxycodone 300 ng/ml

This test kit is used to obtain a visual, qualitative result and is intended for professional use. It is not intended for over the counter sale.

This assay provides only a preliminary result. A more specific alternative 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.

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The provided text is a 510(k) clearance letter from the FDA for a drug screen test cup. It does not contain the detailed study information or acceptance criteria to fully answer the request. The document describes the device's intended use and the substances it tests for with their respective cutoff concentrations, but it does not include data on the device's performance (e.g., sensitivity, specificity), the study design, sample sizes, expert qualifications, or ground truth establishment.

Therefore, I cannot populate the table or provide the requested details about the study that proves the device meets acceptance criteria. The information provided in the document is limited to regulatory clearance and device specifications.

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The Amedica Drug Screen THC, COC, OPI, AMP, MET, PCP, MDMA, BAR, BZO, MTD, TCA, PPX, OXY Test Cup is an in vitro diagnostic test for the rapid detection of THC, benzoylecgonine, morphine, amphetamine, methamphetamine, phencyclidine, barbiturates, benzodiazepines, methadone, tricyclic antidepressants, MDMA. propoxyphene and oxycodone in human urine at the following cutoff concentration:

THC: 11-nor-Δ⁹-Tetrahydrocannabinol-9-carboxylic, 50 ng/ml
COC: Benzoylecgonine, 300 ng/ml
OPI: Morphine, 2000 ng/ml
OPI: Morphine, 300 ng/ml
AMP: Amphetamine, 1000 ng/ml
MET: Methamphetamine, 1000 ng/ml
PCP: Phencyclidine, 25 ng/ml
MDMA: 3,4 methylenedioxymethamphetamine, 500 ng/ml
BAR: Secobarbital, 300 ng/ml
BZO: Oxazepam, 300 ng/ml
MTD: Methadone, 300 ng/ml
TCA: Nortriptyline, 1000 ng/ml
PPX: Propoxyphene, 300 ng/ml
OXY: Oxycodone, 300 ng/ml

This test kit is used to obtain a visual, qualitative result and is intended for professional use. It is not intended for over the counter sale. This assay provides only a preliminary result. A more specific alternative chemical method is needed to obtain a confirmed result.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C)

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This FDA 510(k) clearance document for the Amedica Drug Screen Test Cup does not contain the detailed study information required to answer many of your questions. This document is a clearance letter, essentially stating that the device is substantially equivalent to legally marketed predicate devices, not a detailed technical report of the studies performed.

Therefore, I can only provide limited information based on the text provided.

Here's what I can extract and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present "acceptance criteria" in a typical table format that would include metrics like sensitivity, specificity, or accuracy. Instead, it defines the "indications for use" by listing the specific drugs detected and their respective cutoff concentrations. The "reported device performance" is not detailed in terms of performance metrics but rather by stating that the device detects these substances at the given cutoffs. An explicit comparison of performance against pre-defined acceptance criteria is not present in this document.

Note: The document only states that the device detects these substances at the specified cutoff concentrations. It does not provide metrics like sensitivity or specificity, nor does it explicitly list quantitative acceptance criteria in terms of performance. The "acceptance criteria" here are implied by the cutoff concentrations for detection.

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

Not specified in the document. This document is a regulatory clearance letter, not a full study report. Information on sample size for testing or data provenance (e.g., country of origin, retrospective/prospective) is not included.

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

Not applicable/Not specified. For a rapid drug screen test, the "ground truth" is typically established by laboratory confirmation methods (e.g., GC/MS), not by human expert consensus or interpretation of images/signals. The document does not describe the methodologies or personnel involved in establishing such ground truth.

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

Not applicable/Not specified. Adjudication methods like "2+1" or "3+1" are typically used in studies involving human interpretation of complex data (e.g., medical images). For a diagnostic device that provides a qualitative result based on a chemical reaction, such adjudication is not relevant. The document does not mention any adjudication method for its performance evaluation.

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

Not applicable. This device is a rapid in vitro diagnostic test cup, not an AI-powered system or a device that requires human "readers" in the context of image analysis or complex interpretation where an MRMC study would be relevant. There is no mention of AI assistance or human-in-the-loop performance improvement.

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

Yes, implicitly. This is a standalone diagnostic test cup. Its performance is evaluated purely based on its ability to detect the specified substances at the given cutoffs without any human interpretation enhancement (like an algorithm would provide in image analysis). The device provides a "visual, qualitative result" intended for professional use, but this referes to reading the test lines, not complex diagnostic interpretation.

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

Implicitly, laboratory confirmation methods (e.g., a reference standard like GC/MS). For in vitro diagnostic drug tests, the ground truth for presence/absence of a drug and its concentration is typically established using highly accurate analytical chemistry methods performed in a laboratory, such as Gas Chromatography-Mass Spectrometry (GC/MS) or Liquid Chromatography-Mass Spectrometry (LC/MS). The document describes the test cup providing a "preliminary result" and states that "A more specific alternative chemical method is needed to obtain a confirmed result," which reinforces that laboratory-based analytical methods would be the ground truth.

8. The sample size for the training set

Not applicable/Not specified. This is a chemical immunoassay test, not a machine learning or AI-based device that would require a "training set" in the computational sense. The document does not describe any training set data.

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

Not applicable. As stated above, this device does not utilize a training set in the AI/machine learning sense.

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The Amedica Drug Screen THC/COC, OPI300, PPX, OXY, BAR/BZO Test is an in vitro diagnostic test for the rapid detection of THC, benzoylecgonine, morphine, oxycodone, secobarbital and oxazepam in human urine at the following cut-off concentration

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The provided 510(k) clearance letter and its associated documents (pages 1-3) offer limited information regarding the specific acceptance criteria and detailed study data typically found in a comprehensive medical device submission. This submission appears to be for an in-vitro diagnostic (IVD) drug screen test, which often relies on analytical performance rather than clinical efficacy studies with human readers.

Based on the available text, here's what can be inferred and what information is missing:

1. A table of acceptance criteria and the reported device performance

The document specifies "cut-off concentrations" for each drug, which serve as a critical component of the acceptance criteria for a qualitative drug test. The device's performance would be measured against these cut-offs, typically in terms of accuracy (e.g., sensitivity and specificity) at or around these concentrations. However, the reported device performance values (e.g., sensitivity, specificity, accuracy) are not included in the provided text.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. For an IVD, a test set would typically involve a specific number of both negative and positive urine samples (spiked or clinical) tested against the device. The data provenance would detail if the samples were collected retrospectively or prospectively, and their origin.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided and is generally not applicable in the same way it would be for an imaging AI device. For an IVD like a drug screen, the "ground truth" for the test set is established through a definitive analytical method, not human expert consensus.

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

This information is not provided. Adjudication methods are typically used when there is disagreement among human readers or when a definitive ground truth is difficult to establish through a single method. For a drug test, the ground truth is established by a confirmatory analytical method, so an adjudication method among experts is not relevant.

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 information is not provided and is not applicable for this type of IVD device. MRMC studies are relevant for imaging or diagnostic devices where human interpretation is a key component and AI provides assistance. This device is a standalone qualitative drug screen. While "trained users" are mentioned, the device itself is not an AI or an assistance tool for human interpretation.

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

Yes, this device is a standalone qualitative drug screen. The "algorithm" here refers to the biochemical reactions and visual readout mechanism of the test itself, not a digital algorithm in the context of AI. The performance evaluation would have been done to assess the accuracy of the test in detecting the target analytes at or above the specified cut-off concentrations, without human intervention in the result determination beyond visual interpretation of the test line. The document does state: "This assay provides only a preliminary result... To obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas chromatography/mass spectroscopy (GC/MS) is the recommended confirmatory method." This clearly indicates the device's standalone role in providing an initial, qualitative result.

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

The type of ground truth for an IVD drug screen is typically established by:

• Confirmatory Analytical Methods: Specifically, the document mentions Gas Chromatography/Mass Spectroscopy (GC/MS) as the recommended confirmatory method for obtaining a confirmed analytical result. This is the gold standard for drug detection and quantification in urine.
• Known Concentration Samples: Testing would also involve "spiked" urine samples where known concentrations of the drugs are added, allowing for precise determination of the device's accuracy at different concentrations, especially around the cut-off.

8. The sample size for the training set

This information is not provided. For an IVD of this nature, there isn't a "training set" in the machine learning sense. Instead, the device's design and manufacturing process would be refined based on extensive R&D and internal testing to optimize its performance characteristics (e.g., sensitivity, specificity, stability, reproducibility) before validation studies.

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

As there isn't a "training set" in the AI sense, this question is not applicable. The underlying chemical principles and immunoassay design are "trained" through biochemical research and optimization, with performance verified against known concentrations of analytes and confirmed by methods like GC/MS during development.

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The Amedica Drug Screen MDMA-BAR-BZO-MTD-TCA Test is an in vitro diagnostic test for the rapid detection of 3,4 methylenedioxymethamphetamine, secobarbital, oxazepam, methadone and nortriptyline in human urine at the following cut-off concentration.

This test kit is used to obtain a visual, qualitative result and is intended for professional use. It is not intended for over the counter sale.

Membrane based one-step, lateral flow, competitive immunoassay use colloidal gold for visual detection of 3,4 methylenedioxymethamphetamine, secobarbital, oxazepam, methadone and nortriptyline.

Here's an analysis of the provided text regarding the Amedica Drug Screen MDMA-BAR-BZO-MTD-TCA Test, focusing on acceptance criteria and the supporting study:

Acceptance Criteria and Device Performance

Note: The document only provides a single summary performance metric ("> 94% agreement") for the entire panel of drugs when compared to GC/MS. It does not break down the performance for each individual drug.

Study Details

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

   • Sample Size: The document does not specify the exact sample size for the "blind-labeled specimens" used in the correlation study.
   • Data Provenance: The data provenance is not explicitly stated (e.g., country of origin). The specimens were "blind-labeled," implying they were collected prior to the study. This suggests a retrospective data collection approach for this part of the study. Separately, a "clinical site study" was performed at a "certified laboratory," suggesting a prospective clinical evaluation, but details are not provided.

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

   • The ground truth was established by GC/MS (Gas Chromatography/Mass Spectrometry), which is an analytical laboratory method, not human experts. Therefore, the concept of "number of experts" or their "qualifications" doesn't directly apply in the way it would for image interpretation or subjective medical assessments.

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

   • Not applicable. As the ground truth was established by GC/MS, there was no human adjudication process involved for resolving discrepancies between multiple expert readings.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly described.
   • The device is a qualitative immunoassay for drug detection, where the reading is visual and interpreted by a single professional. It's not an AI-assisted diagnostic tool that would typically involve human readers interpreting complex data.
   • Therefore, the concept of an "effect size of how much human readers improve with AI vs without AI assistance" does not apply here.

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

   • Yes, a standalone performance assessment was effectively done. The "correlation study using blind-labeled specimens that have been measured by GC/MS" and stating "> 94% agreement with GC/MS results" represents the standalone performance of the device's ability to detect the target substances. The "clinical site study" further validated its use by professionals, implying that the device's output (visual lines) is directly interpreted.

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

   • The primary ground truth used was GC/MS (Gas Chromatography/Mass Spectrometry), which is a gold standard analytical method for confirming drug presence and concentration in urine samples.

7. The sample size for the training set:

   • The document does not explicitly mention a "training set" or its size, as this device is a competitive immunoassay, not a machine learning algorithm that typically requires a distinct training phase. Its design and performance are based on chemical and immunological principles.

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

   • Not applicable, as no explicit training set for a machine learning algorithm was described. The performance of the immunoassay is inherent to its biochemical design.

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The Amedica Drug Screen Amphetamine Test is a immunochromatographic assay for the rapid detection of Amphetamine in human urine at a cutoff concentration of 1000 ng/ml. This assay has not been evaluated at point-of-care locations and is intended for use by healthcare professionals.

This assay provides only a preliminary result. A more specific alternative chemical method is needed to obtain a confirmed result.

The Amedica Drug Screen Amphetamine Test is an in vitro diagnostic test for the rapid detection of amphetamine in human urine at a cutoff of 1000 ng/ml. This test kit is used to obtain a visual, qualitative result and is intended for professional use. It is not intended for over the counter sale.

This assay provides only a preliminary result. A more specific alternative chemical method is needed to obtain a confirmed result.

Membrane based one-step, lateral flow, competitive immunoassay use colloidal gold for visual detection. The cutoff is 1000 ng/ml.

Acceptance Criteria and Study for Amedica Drug Screen Amphetamine Test

This document outlines the acceptance criteria for the Amedica Drug Screen Amphetamine Test and the study proving its performance.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The provided text does not explicitly state numerical acceptance criteria for agreement or qualitative detection. The "Performance" section describes the study results as demonstrating the device meets the intended purpose and is comparable to a predicate.

2. Sample Size and Data Provenance

• Test Set Sample Size: Not explicitly stated. The study used "blind-labeled clinical specimens" and was a "correlation study."
• Data Provenance:
  • Country of Origin: Not explicitly stated, but the manufacturer is based in Hayward, CA, and the FDA's address is in Rockville, MD, suggesting a US-centric study.
  • Retrospective or Prospective: Not explicitly stated. The use of "blind-labeled clinical specimens" could suggest either if they were collected for another purpose and then retrospectively analyzed, or if they were collected prospectively for this study. The term "correlation study" doesn't clarify this either.

3. Number and Qualifications of Experts for Ground Truth

• Number of Experts: Not applicable, as the primary ground truth for the correlation study was established by GC/MS, an analytical chemical method, not human interpretation.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The ground truth was established by GC/MS, which is an objective chemical analysis, not subject to human adjudication for its results.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is a rapid diagnostic test with a visual qualitative result, not an image-based or complex diagnostic system typically requiring MRMC studies. The "clinical site study" mentioned involved professionals using the device, but it was to demonstrate usability and qualitative detection, not to measure improvement with AI assistance or compare human readers.

6. Standalone (Algorithm Only) Performance Study

• Standalone Performance Study: Yes, in essence, the "correlation study using blind-labeled clinical specimens that have been measured by GC/MS" represents a standalone performance evaluation of the device itself. The device is a "membrane based one-step, lateral flow, competitive immunoassay," which operates as a standalone diagnostic without human interpretation beyond reading the visual result. The >97% agreement refers to the device's inherent performance compared to a gold standard.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth for the primary correlation study was Gas Chromatography/Mass Spectrometry (GC/MS). The text states, "This study produced > 97% agreement with GC/MS results," indicating GC/MS served as the reference standard. This is an objective, highly accurate analytical method for drug detection and quantification in urine.

8. Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This device is a chemical immunoassay, not a machine learning or AI-based algorithm that requires a "training set" in the conventional sense. Its design and performance are based on chemical reactions and physical properties.

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

• Ground Truth for Training Set: Not applicable, as there is no "training set" for this type of device. The immunoassay's specificity and sensitivity are inherent to its chemical design.

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The Amedica Drug Screen Phencyclidine Test is an in vitro diagnostic test for the rapid detection of Phencyclidine in human urine at a cutoff of 25 ng/ml. This test kit is used to obtain a visual, qualitative result and is intended for professional use. It is not intended for over the counter sale.

This assay provides only a preliminary result. A more specific alternative chemical method is needed to obtain a confirmed result.

Membrane based one-step, lateral flow, competitive immunoassay use colloidal gold for visual detection. The test cutoff is 25 ng/ml.

Here's a breakdown of the acceptance criteria and study information for the Amedica Drug Screen Phencyclidine Test, based on the provided text:

Acceptance Criteria and Reported Device Performance

Note: The document states "This study produced > 93% agreement with GC/MS results," implying this met their acceptance for accuracy.

Study Details

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

• Sample Size (Test Set): Not explicitly stated. The document mentions "blind-labeled clinical specimens" for the correlation study and a "clinical site study" at two certified laboratories. It does not provide the exact number of specimens used in either study.
• Data Provenance: Not explicitly stated, but "clinical specimens" and "clinical site study" at certified laboratories imply real-world human urine samples. There is no mention of country of origin, but the manufacturer is based in California, USA, suggesting the studies likely occurred in the USA. The studies were retrospective as they involved "blind-labeled clinical specimens that have been measured by GC/MS," indicating the GC/MS results were pre-existing.

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

• The ground truth for the test set was established by GC/MS (Gas Chromatography/Mass Spectrometry), which is a highly accurate analytical method, not human experts in this context. Therefore, the number and qualifications of human experts for ground truth are not applicable here.

4. Adjudication method for the test set

• Not applicable. The ground truth was established by GC/MS, an objective chemical method, not through human adjudication.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or performed. This device is an immunoassay for drug detection, where the "reading" is a visual interpretation of a test line, not a complex image interpretation typically associated with AI in an MRMC study. The product's intended use is for "professionals" but does not describe any human-in-the-loop AI assistance.

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

• Yes, the performance evaluation primarily focuses on the standalone performance of the immunoassay itself. The "correlation study using blind-labeled clinical specimens that have been measured by GC/MS" directly assesses the device's accuracy without explicit mention of human interpretation variability. The "clinical site study" confirms its usability by professionals to obtain a visual result, but the core performance data comes from the comparison to GC/MS.

7. The type of ground truth used

• GC/MS (Gas Chromatography/Mass Spectrometry): This is a gold standard analytical method for identifying and quantifying substances in a sample, providing a highly reliable and objective ground truth.

8. The sample size for the training set

• Not applicable. This device is a diagnostic immunoassay, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. Its performance is based on the chemical reactions and design of the test strip.

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

• Not applicable, as there is no "training set" for this type of device.

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The Amedica Drug Screen Methamphetamine Test is a immunochromatographic assay for the rapid detection of methamphetamine in human urine at a cutoff concentration of 1000 ng/ml. This assay has not been evaluated at point-of-care locations and is intended for use by healthcare professionals. This assay provides only a preliminary result. A more specific alternative chemical method is needed to obtain a confirmed result.

Membrane based one-step, lateral flow, competitive immunoassay use colloidal gold for visual detection. The test cutoff is 1000 ng/ml.

Here's an analysis of the provided text regarding the Amedica Drug Screen Methamphetamine Test, structured to address your specific points:

Acceptance Criteria and Study Details for Amedica Drug Screen Methamphetamine Test

The information provided is from a 510(k) premarket notification for a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than establishing de novo performance criteria against a predefined set of acceptance values. Therefore, the "acceptance criteria" for this device are implicitly tied to demonstrating performance comparable to the predicate device and achieving a high level of agreement with a confirmatory method (GC/MS).

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: The text mentions a "correlation study using blind-labeled clinical specimens" and a "clinical site study." However, the specific number of samples (sample size) for these test sets is not explicitly stated in the provided document.
• Data Provenance:
  • Country of Origin: Not specified.
  • Retrospective or Prospective: Not specified. The use of "clinical specimens" implies a real-world context, but whether they were collected specifically for this study (prospective) or were pre-existing (retrospective) is not detailed.

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

• The document implies that the ground truth for the correlation study was established by Gas Chromatography/Mass Spectrometry (GC/MS) results. GC/MS is an analytical chemistry technique, not a human expert. Therefore, the concept of "number of experts" is not directly applicable in this context.
• For the "clinical site study," human professionals (implied to be healthcare professionals working in certified laboratories) used the device. However, their role was to use the device, not to establish a separate ground truth against which the device was compared. The ground truth for this validation would still likely refer back to objective analytical methods or the predicate device's performance.
• Qualifications of Experts: Not applicable, as GC/MS is an instrumental method. For the clinical site study, the "professionals" were working in "two certified laboratories," implying they were qualified given the laboratory accreditation.

4. Adjudication Method for the Test Set

• None specified. The "correlation study" used GC/MS as the reference standard, which is an objective analytical method. There's no mention of multiple human readers or an adjudication process for the GC/MS results themselves or for the visual test results from the Amedica device to establish a consensus ground truth. The agreement was likely a direct comparison of the device's qualitative result (positive/negative) against the quantitative GC/MS result relative to the 1000 ng/ml cutoff.

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

• No, an MRMC comparative effectiveness study was not explicitly mentioned or clearly conducted. The focus was on the device's performance against GC/MS and its substantial equivalence to a predicate device. While a "clinical site study" was performed, it describes the device being "use by professionals" rather than a formal MRMC study comparing human readers with and without AI assistance to measure an effect size.

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

• Yes, in essence, the "correlation study" is a standalone evaluation of the device's analytical performance. The "Amedica Drug Screen Methamphetamine Test" is a lateral flow immunoassay that provides a visual qualitative result. While a human physically interprets the lines on the strip, the device itself is a "standalone" diagnostic rather than an AI algorithm that augments human interpretation. The reported agreement of "> 94% agreement with GC/MS results" directly reflects this standalone performance.

7. Type of Ground Truth Used

• Expert Consensus: No.
• Pathology: No (this is for drug detection, not tissue pathology).
• Outcomes Data: No.
• Other: The primary ground truth for evaluating the device's accuracy was Gas Chromatography/Mass Spectrometry (GC/MS), which is a highly specific and sensitive analytical method considered the gold standard for drug confirmation.

8. Sample Size for the Training Set

• Not applicable / Not specified. This device is a competitive immunoassay, not an AI/machine learning algorithm that requires a "training set" in the conventional sense. The "training" in this context would refer to the development and optimization of the immunoassay reagents and manufacturing process, which doesn't typically involve a distinct data "training set" like AI models do.

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

• Not applicable. As mentioned above, there isn't a "training set" in the machine learning sense for this type of device. The immunoassay's specificity and sensitivity are inherent in its chemical design and production, not learned from a dataset.

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