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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)

Not Found

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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