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The CHECKCUP™ Multi-Drug Test is a one-step immunoassay for the qualitative detection of multiple drugs and drug metabolites in human urine at the following cutoff concentrations:

The CHECKCUP™ Multi-Drug Test consists of two test formats: flat cup and round cup. The configurations of the CHECKCUP™ Multi-Drug Test consist of any combination of the drugs listed above. The CHECKCUP™ is used to obtain a visual, qualitative result and is intended for professional use only.

This assay provides only a preliminary result. Clinical consideration and professional judgment must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/Mass Spectrometry (GC/MS) and Liquid Chromatography/Mass Spectrometry (LC/MS) are the preferred confirmation methods.

The Ameditech CHECKCUP™ Multi-Drug Test is a lateral flow immunoassay intended for professional (prescription) use only. The device is used for the qualitative determination of parent compound and/or major metabolites of drugs in human urine specimens, and results are read visually. The device will be made available in two formats that use identical test strips: Round Cup and Flat Cup. The modified device contains up to seventeen (17) assays that include fourteen (14) different drugs at various cutoff concentrations. The assays detect different illicit drugs and medications that are commonly abused. Once the urine sample is administered, negative results can be read as soon as 1 minute and positive results should be read between 5 to 10 minutes. The presence of the line on the test region indicates a negative result for the drug and the absence of a line on the test region indicates a positive result for the drug. A visible line is also present at the control region of the test strip. This line should always appear, regardless of the presence of drugs or metabolites in the urine sample. This means that a negative urine sample will produce both a test line and control line, and a positive urine sample will generate only a control line. The presence of control line serves as a built-in control, which demonstrates that the test is performed properly.

Here's an analysis of the provided text regarding the Ameditech CHECKCUP™ Multi-Drug Test, focusing on acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in terms of sensitivity, specificity, or accuracy percentages for the CHECKCUP™ Multi-Drug Test. Instead, it relies on demonstrating equivalence to predicate devices. The implicit acceptance criterion is that the modified device performs "as well or better than the predicate device" across various analytical performance characteristics.

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

The document explicitly states that no clinical studies were conducted for this special 510(k) submission (Section E). The performance characteristics were validated in the predicate submissions (K053175 and K113046) and are considered applicable to the modified device.

The study described is a "simplified performance studies" and "analytical performance verification and validation testing." Details on sample sizes for these analytical studies are not provided in the given text.

The data provenance is implied to be from Ameditech, Inc. (the submitter) and likely from internal laboratory testing, given the analytical nature of the studies discussed. There is no mention of country of origin of the data or whether it was retrospective or prospective, though analytical testing is typically prospective in nature.

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

This information is not applicable as no clinical studies were performed. The "ground truth" for the analytical studies would have been established by laboratory methods, not by expert consensus on patient cases.

4. Adjudication Method for the Test Set

This information is not applicable as no clinical studies were performed.

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 applicable. The device is a qualitative lateral flow immunoassay intended for visual reading by a professional, not an AI system. No MRMC study was conducted.

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

The device is a lateral flow immunoassay that requires visual interpretation by a human professional. Therefore, the concept of "standalone (algorithm only)" performance is not applicable in the context of AI. The performance validated here is inherent to the chemical reactions and visual indicators on the test strip, which are read by a human.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

For the analytical performance studies (sensitivity, specificity, precision, interfering substances), the ground truth would have been established by reference laboratory methods (e.g., Gas Chromatography/Mass Spectrometry (GC/MS) and Liquid Chromatography/Mass Spectrometry (LC/MS) are mentioned as preferred confirmation methods for positive results, implying these or similar techniques would be used for analytical validation). The document explicitly states, "In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/Mass Spectrometry (GC/MS) and Liquid Chromatography/Mass Spectrometry (LC/MS) are the preferred confirmation methods."

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of machine learning or AI. The device is a chemical immunoassay kit. Therefore, this concept is not applicable in the traditional sense. The development of the test strips and their performance characteristics would have been optimized through iterative laboratory testing and formulation, but not a "training set" as understood in AI/ML.

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

As no "training set" in the AI/ML sense is mentioned or implied, this question is not applicable. The underlying principles of an immunoassay rely on antibody-antigen reactions, and the "ground truth" for developing such a device would be based on known concentrations of substances and established analytical reference methods.

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The ImmuTest Multi-Drug Screen is a one-step immunoassay for the qualitative detection of multiple drugs and drug metabolites in human urine at the following cutoff concentrations:

The ImmuTest Multi-Drug Screen consists of three test formats: card, cassette and cup. The configurations of the ImmuTest Multi-Drug Screen consist of any combination of the drugs listed above. The ImmuTest Multi-Drug Screen is used to obtain a visual, qualitative result and is intended for professional use only.

This assay provides only a preliminary result. Clinical consideration and professional judgment must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/Mass Spectrometry (GC/MS) and Liquid Chromatography/Mass Spectrometry (LC/MS) are the preferred confirmation methods.

The Ameditech ImmuTest Multi-Drug Screen is a lateral flow immunoassay intended for professional (prescription) use only. The device is used for the qualitative determination of parent compound and/or major metabolites of drugs in human urine specimens, and results are read visually. The device will be made available in three formats that use identical test strips: Dipcard, Cassette, and Cup. The modified device contains up to seventeen (17) assays that can include up to thirteen (13) different drugs at various cutoff concentrations. The assays detect different illicit drugs and medications that are commonly abused. Once the urine sample is administered, negative results can be read as soon as 1 minute and positive results should be read between 5 to 10 minutes. The presence of the line on the test region indicates a negative result for the drug and the absence of a line on the test region indicates a positive result for the drug. A visible line is also present at the control region of the test strip. This line should always appear, regardless of the presence of drugs or metabolites in the urine sample. This means that a negative urine sample will produce both a test line and control line, and a positive urine sample will generate only a control line. The presence of control line serves as a built-in control, which demonstrates that the test is performed properly.

Here's an analysis of the acceptance criteria and the study information for the Ameditech ImmuTest Multi-Drug Screen, based on the provided text:

Acceptance Criteria and Device Performance

The provided document describes a Special 510(k) submission, meaning the device is substantially equivalent to a previously cleared predicate device. Therefore, the "acceptance criteria" are implicitly met by demonstrating equivalent performance to the predicate. The "reported device performance" is essentially the established performance of the predicate devices.

Table 1: Acceptance Criteria (Referencing Predicate Performance) and Reported Device Performance

Study Details

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

   • The document states that no clinical studies were conducted for this special 510(k) submission because the modified and predicate devices use identical test strips. Therefore, there is no new test set with specific sample sizes for this submission. The performance characteristics validated in the predicate submissions are considered applicable. The original provenance of data for predicate devices is not specified in this document.

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 applicable as no new clinical or performance studies were conducted for this submission. The ground truth (drug presence/absence and concentration) for the predicate device studies would have been established through methods like GC/MS or LC/MS, but the specific number and qualifications of experts involved in those prior studies are not detailed here.

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

   • Not applicable as no new clinical or performance studies were conducted for this submission.

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 device is a manual, visually-read immunoassay for drug detection and does not involve AI or human-in-the-loop performance in the context of diagnostic imaging or similar applications where MRMC studies are common.

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

   • Not applicable. This device is a visually-read immunoassay and does not have a "standalone algorithm" in the typical sense of AI/image analysis. Its performance is inherent to the chemical reaction on the test strip and the visual interpretation.

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

   • For the predicate devices (and hence assumed for this modified device), the ground truth for drug presence and concentration in urine samples would have been established through more specific alternate chemical methods, primarily Gas Chromatography/Mass Spectrometry (GC/MS) and Liquid Chromatography/Mass Spectrometry (LC/MS). These are stated as the preferred confirmation methods for preliminary positive results.

7. The sample size for the training set

   • Not applicable. This device is a chemical immunoassay, not a machine learning model that requires a training set.

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

   • Not applicable for the reason stated above.

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The Ameditech ImmuTest Multi-Drug Screen BUP/PPX/COC150 is an In Vitro screen test device for the qualitative detection of multi-drugs in human urine. The cutoff concentrations for this panel test are as follows.

This test uses multiple test strips in card format (test strips are placed in a card strip holder), cassette format (test strips are placed in a cassette strip holder), and cup format (test strips are placed in a lid strip holder).

This test is used to obtain a visual, qualitative result and is intended for professional use.

This assay provides only a preliminary result. Clinical consideration and professional judgment must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/Mass Spectroscopy (GC/MS) is the preferred confirmation method.

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

The Ameditech ImmuTest Multi-Drug Screen BUP/PPX/COC150 is an In Vitro screen test device for the qualitative detection of multi-drugs in human urine. This test uses multiple test strips in card format (test strips are placed in a card strip holder), cassette format (test strips are placed in a cassette strip holder), and cup format (test strips are placed in a lid strip holder). This test is used to obtain a visual, qualitative result and is intended for professional use.

This document is a 510(k) clearance letter from the FDA for a multi-drug screen device. It acknowledges the device's substantial equivalence to legally marketed predicate devices. However, the provided text does not contain the acceptance criteria or a study detailing the device's performance against such criteria. It only describes the product, its intended use, and cutoff concentrations for the substances it detects.

Therefore, I cannot extract the information required in your request from the provided text.

To provide the requested details, I would need a different document that outlines a performance study, including:

• A table of acceptance criteria and reported device performance (sensitivity, specificity, accuracy, etc.)
• Details on sample size, data provenance, ground truth establishment, and expert qualifications.

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The Ameditech DrugSmartCup™ is an In Vitro screen test device for the qualitative detection of drugs in human urine. This test is used to obtain a visual, qualitative result and is intended for professional use. This assay provides only a preliminary result. Clinical consideration and professional judgment must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/Mass Spectroscopy (GC/MS) is the preferred confirmation method.

Not Found

Here's a breakdown of the acceptance criteria and study information for the Ameditech DrugSmartCup™ based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA letter does not explicitly state "acceptance criteria" in terms of performance metrics (e.g., sensitivity, specificity thresholds). However, it implies that the device's performance, as demonstrated in the submission, was deemed substantially equivalent to legally marketed predicate devices. The listed "Indications for Use" and the table of "Cutoff concentrations" define the intended analytical performance of the device.

Reported Device Performance: The document only states that the device was found "substantially equivalent" to legally marketed predicate devices for the specified indications. It does not provide specific performance metrics like sensitivity, specificity, or accuracy percentages from Ameditech's study. The cutoff concentrations in the table are the definition of the expected performance for a positive/negative result.

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

The provided FDA letter does not contain information regarding the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). This level of detail would typically be found in the 510(k) submission itself, not the FDA's decision letter.

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

The provided FDA letter does not contain information about the number of experts used or their qualifications for establishing ground truth for the test set.

4. Adjudication Method for the Test Set

The provided FDA letter does not specify any adjudication method used for the test set.

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

No, an MRMC comparative effectiveness study is not applicable to this type of in-vitro diagnostic device (a qualitative screen test for drugs in urine). MRMC studies are typically used for imaging diagnostics where human readers interpret results. This device produces a visual, qualitative result that is read directly, not interpreted by multiple human readers in a comparative setting against an AI.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, this device inherently functions as a standalone test. It's an "In Vitro screen test device for the qualitative detection of drugs in human urine" that provides a "visual, qualitative result." While human eyes read the result, there is no separate "algorithm" being evaluated against human-in-the-loop performance in the way an AI algorithm for medical imaging would be. The device itself is the "algorithm" in a chemical sense.

7. The Type of Ground Truth Used

The ground truth for a drug screening device like this would typically be established by a more definitive analytical method. The document explicitly states: "In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/Mass Spectroscopy (GC/MS) is the preferred confirmation method." Therefore, GC/MS is the type of ground truth used to determine the actual presence and concentration of drugs to validate the device's accuracy.

8. The Sample Size for the Training Set

The provided FDA letter does not contain information regarding the sample size used for any training set. This device is not an AI/ML algorithm that is "trained" in the typical sense; it is a chemical immunoassay.

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

As this is a chemical immunoassay rather than a machine learning algorithm requiring a "training set" in the AI sense, this question is not directly applicable. However, if this refers to the development and calibration of the assay, the "ground truth" for calibrating the device would involve spiking urine samples with known concentrations of the target analytes and confirming those concentrations with a gold standard like GC/MS to ensure the device correctly identifies positive/negative relative to the established cutoffs.

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The Ameditech ImmuTest Multi-Drug Screen Panel III is an In Vitro screen test device for the qualitative detection of multi-drugs in human urine. This test is used to obtain a visual, qualitative result and is intended for professional use. This assay provides only a preliminary result. Clinical consideration and professional judgment must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/Mass Spectroscopy (GC/MS) is the preferred confirmation method.

The Ameditech ImmuTest Multi-Drug Screen Panel III is an In Vitro screen test device for the qualitative detection of multi-drugs in human urine. This test uses multiple test strips in card format (test strips are placed in a card strip holder), cassette format (test strips are placed in a cassette strip holder), and cup format (test strips are placed in a lid strip holder).

Here's a breakdown of the acceptance criteria and study information based on the provided document:

This document is a 510(k) clearance letter for a drug screening device, not a detailed study report. Therefore, much of the requested information (like specific sample sizes for test and training sets, expert qualifications, adjudication methods, or MRMC studies) is not present in this type of regulatory correspondence. The document focuses on the intended use and performance characteristics as claimed by the manufacturer and accepted by the FDA based on a comparison to predicate devices, rather than a detailed accounting of a specific clinical performance study.

However, I can extract the acceptance criteria as presented for each drug panel.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for each drug are defined by the "Cutoff (ng/ml)" concentration. The device is expected to qualitatively detect the presence of the specified drug at or above these cutoff concentrations. The document does not provide a table of reported device performance in terms of sensitivity, specificity, accuracy, or concordance with a gold standard from a specific study within this letter. Instead, it states the intended use is for qualitative detection relative to these cutoffs.

Specific Study Information (Based on available document content):

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

   • Sample Size: Not specified in this document.
   • Data Provenance: Not specified in this document. Typically, for in vitro diagnostic devices, studies involve spiked urine samples and/or clinical urine samples. The document does not state country of origin or if prospective/retrospective.

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

   • Not applicable/Not specified. For in vitro diagnostic assays, ground truth is typically established by definitive analytical methods (like GC/MS) rather than expert consensus on visual interpretation.

3. Adjudication method for the test set:

   • Not applicable/Not specified. This refers to consensus among human readers for image interpretation, which is not relevant for this type of qualitative chemical test.

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 not an AI-assisted diagnostic device, nor does it involve human readers interpreting complex images. It is a rapid qualitative immunoassay.

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

   • Partially applicable. The device is a standalone qualitative test. The "output" is a visual indication (e.g., lines on a strip). However, the document states, "This assay provides only a preliminary result. Clinical consideration and professional judgment must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result." This indicates that while the device itself performs the detection without human intervention, its results require expert clinical interpretation and confirmation by a more specific method.

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

   • The document implies that the ultimate ground truth for confirmation is a "more specific alternate chemical method," with "Gas Chromatography/Mass Spectroscopy (GC/MS) [being] the preferred confirmation method."

7. The sample size for the training set:

   • Not specified in this document. Immunoassays are often "trained" or optimized during development using various concentrations of analytes and interferents, but this is a manufacturing/development process, not typically reported with a "training set" size in the same way as an AI algorithm.

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

   • Not specified in this document. As with the test set, it would typically involve spiking known concentrations of drugs into urine samples or using characterized clinical samples, with definitive analytical methods (like GC/MS) used to establish the true concentration/presence.

Summary of Device and Approval Context:

This FDA 510(k) clearance letter indicates that the Ameditech ImmuTest Multi-Drug Screen Panel III is a qualitative in-vitro diagnostic device for detecting multiple drugs in human urine. Its "acceptance criteria" are the specified cutoff concentrations for each drug metabolite. The FDA determined that this device is "substantially equivalent" to legally marketed predicate devices, meaning that its performance, safety, and effectiveness are considered comparable. The letter does not provide a detailed clinical study report but rather acts as regulatory approval based on the manufacturer's submission demonstrating substantial equivalence. The "study" mentioned generally refers to the performance data submitted by the manufacturer to demonstrate this substantial equivalence to predicate devices, which would have included data to support the stated cutoffs and qualitative detection capabilities.

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The Ameditech ImmuTest Multi-Drug Screen Panel II is an In Vitro screen test device for the qualitative detection of multi-drugs in human urine. The cutoff concentrations for this panel test are as follows.

| Test | Calibrator | Cutoff
(ng/ml) |
|--------------------------------------------|----------------------------------|-------------------|
| Barbiturates (BAR) | Secobarbital | 300 |
| Benzodiazepines (BZO) | Oxazepam | 300 |
| 3,4methylenedioxymethamphetamine
(MDMA) | 3,4methylenedioxymethamphetamine | 500 |
| Methamphetamine (MET1000) | d-Methamphetamine | 1000 |
| Methadone (MTD) | Methadone | 300 |
| Opiates (OPI300) | Morphine | 300 |
| Oxycodone (OXY) | Oxycodone | 100 |

This test has three types of test format: card format (test strips are placed in a card strip holder), cassette format (test strips are placed in a cassette strip holder), and cup format (test strips are placed in a lid strip holder).

This test is used to obtain a visual, qualitative result and is intended for professional use.

This assay provides only a preliminary result. Clinical consideration and professional judgment must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/Mass Spectroscopy (GC/MS) is the preferred confirmation method.

The Ameditech ImmuTest Multi-Drug Screen Panel II is an In Vitro screen test device for the qualitative detection of multi-drugs in human urine. This test has three types of test format: card format (test strips are placed in a card strip holder), cassette format (test strips are placed in a cassette strip holder), and cup format (test strips are placed in a lid strip holder). This test is used to obtain a visual, qualitative result and is intended for professional use.

This document is a 510(k) clearance letter for an in vitro diagnostic device, the Ameditech ImmuTest Multi-Drug Screen Panel II. It does not contain the detailed study information typically found in a clinical trial report or a scientific paper. Therefore, I cannot provide a complete answer to your request based solely on the provided text.

However, I can extract the acceptance criteria and some limited information about the device performance and how the ground truth is established, based on what's available in the "Indications for Use" section.

Here's what I can infer and what is explicitly stated:

1. Table of Acceptance Criteria and Reported Device Performance

The "Indications for Use" section lists the cutoff concentrations for each drug panel. These are the established thresholds for a positive result in this qualitative screen test. While the document doesn't explicitly state "acceptance criteria" for the device's performance (e.g., sensitivity, specificity, accuracy), the cutoff concentrations themselves are a critical part of its intended performance. The document only specifies the design of the test (i.e., its cutoff values), not the performance against clinical samples.

The document states, "This assay provides only a preliminary result." This implies that the device's performance, while meeting regulatory requirements for a screening test, is not definitive and requires confirmation.

Missing Information: The provided text does not contain any data on the device's actual performance (e.g., sensitivity, specificity, accuracy) from a study against these cutoffs. Therefore, I cannot fill in a "Reported Device Performance" column with actual study results.

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

Missing Information: This document does not provide any details about the sample size used for performance testing (test set) or the data provenance (e.g., country of origin, retrospective/prospective). This information would typically be found in a separate study report or the 510(k) submission itself, not in the clearance letter.

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

Missing Information: This device is an in vitro diagnostic test for drug screening. The "ground truth" for such tests is typically established through a "more specific alternate chemical method," as stated in the document. Therefore, human experts (like radiologists) are not involved in establishing the ground truth for the test set in this context.

4. Adjudication method for the test set

Missing Information: Not applicable, as human experts are not involved in establishing the ground truth for this type of device. The adjudication method refers to how disagreements among human readers are resolved.

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 is an in vitro diagnostic device, not an AI-powered image analysis tool for human readers. Therefore, an MRMC study and effects of AI assistance for human readers are irrelevant to this device.

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

The device is described as "an In Vitro screen test device for the qualitative detection of multi-drugs in human urine." It provides "a visual, qualitative result" and is "intended for professional use." This strongly suggests it's a standalone test (algorithm only, in the sense of the chemical reactions on the strip providing the result) that is interpreted by a professional, rather than an AI that acts as an adjunct to a human.

The statement "This assay provides only a preliminary result. Clinical consideration and professional judgment must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result" highlights that while the device is standalone in generating a result, human judgment is critical for its clinical application.

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

The document explicitly states: "In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/Mass Spectroscopy (GC/MS) is the preferred confirmation method."

Therefore, the type of ground truth used for validating the performance of this preliminary screening device would be Gas Chromatography/Mass Spectroscopy (GC/MS) or another highly specific chemical analytical method. This is the gold standard for confirming the presence and concentration of drugs in biological samples.

8. The sample size for the training set

Missing Information: This document does not provide details about a "training set." For in vitro diagnostic devices, the development process might involve numerous experiments and optimization steps, but the concept of a "training set" as used in machine learning (which often implies a distinct, labeled dataset for algorithm development) isn't directly applicable or described here.

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

Missing Information: As mentioned above, the concept of a "training set" in the context of AI is not directly applicable here. If referring to the internal development process of the assay, the ground truth would similarly be established by highly accurate analytical methods like GC/MS to calibrate and validate the chemical reactions on the test panel.

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The Ameditech ImmuTest Drug Screen Panel is a one-step panel immunoassay for the qualitative detection of amphetamine, cocaine metabolite (benzovlecgonine), methamphetamine, opiates, phencyclidine, and THC in human urine. The cutoff concentrations for this panel test are amphetamine at 1000 ng/ml, cocaine metabolite at 300 ng/ml, methamphetamine at 500 ng/ml, opiates at 2000 ng/ml, phencyclidine at 25 ng/ml, and THC at 50 ng/ml. This test kit is used to obtain a visual, qualitative results and is intended for professional use.

Not Found

The provided FDA 510(k) summary (K040092) for the Ameditech ImmuTest Drug Screen Panel does not contain detailed information about the acceptance criteria and the study that proves the device meets them. This document is primarily the FDA's letter of substantial equivalence and the Indications For Use statement.

Therefore, many of the requested details cannot be extracted directly from the given text. However, based on the nature of a 510(k) submission for an in vitro diagnostic device, we can infer some general aspects and fill in what is available within the provided pages.

General Understanding of 510(k) Studies for IVDs:
For in vitro diagnostic devices like drug screens, performance studies typically involve testing known positive and negative samples, as well as samples with drug concentrations around the specified cutoff to determine sensitivity, specificity, and accuracy. The "acceptance criteria" would generally be predefined thresholds for these performance metrics. "Ground truth" for IVDs is usually established by a highly accurate reference method (e.g., GC/MS for drug screening).

Information Available from the Provided Text:

• Device Name: Ameditech ImmuTest Drug Screen Panel
• Intended Use: Qualitative detection of amphetamine, cocaine metabolite (benzoylecgonine), methamphetamine, opiates, phencyclidine, and THC in human urine.
• Cutoff Concentrations:
  • Amphetamine: 1000 ng/ml
  • Cocaine metabolite: 300 ng/ml
  • Methamphetamine: 500 ng/ml
  • Opiates: 2000 ng/ml
  • Phencyclidine: 25 ng/ml
  • THC: 50 ng/ml

Based on the provided text, here is an attempt to answer the questions, with significant limitations due to lack of the actual study report:

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

• Acceptance Criteria: Not explicitly stated in the provided documents. For a qualitative drug screen, typical acceptance criteria would involve a certain percentage of agreement (e.g., >95% or >98%) with a reference method for both positive and negative samples, and high accuracy around the cutoff concentrations.
• Reported Device Performance: Not explicitly stated in the provided documents. The letter only states that the device is "substantially equivalent" to legally marketed predicate devices, implying its performance met the requirements set by the FDA for such devices.

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

• Sample Size (Test Set): Not stated in the provided documents.
• Data Provenance: Not stated in the provided documents. Typically, for IVDs, this would involve clinical samples collected from hospitals, clinics, or drug testing facilities. Most likely, a prospective collection or a defined retrospective bank of samples would be used.

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

• Number of Experts: Not applicable in the typical sense for IVD drug screens.
• Qualifications of Experts: The ground truth for drug screen tests is typically established by an independent, highly accurate reference method, such as Gas Chromatography-Mass Spectrometry (GC/MS) or Liquid Chromatography-Mass Spectrometry (LC/MS), performed by qualified laboratory personnel (e.g., clinical chemists, toxicologists). It does not usually involve expert "readers" in the way imaging studies do.

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

• Adjudication Method: Not applicable for IVD drug screens in the context of expert review. The "adjudication" is essentially the comparison of the device's qualitative result (positive/negative) to the quantitative result of the reference method around the cutoff, confirmed by expert interpretation of the reference method data.

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: Not applicable. This device is a rapid, qualitative immunoassay for drug detection, and the evaluation does not involve human readers interpreting images or complex data, nor does it typically involve AI assistance in the interpretation of the physical test device. The device provides a visual result (e.g., lines appearing).

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

• Standalone Performance: For this type of device, the "standalone performance" is the performance of the immunoassay itself, without human interpretation error. Since it's a visual read, human-in-the-loop is inherent for interpreting the lines, but the primary performance evaluation focuses on the chemical accuracy of the assay. The data provided does not specify how read-out variability was assessed, if at all.

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

• Type of Ground Truth: Likely an objective, highly accurate reference method such as Gas Chromatography-Mass Spectrometry (GC/MS) or Liquid Chromatography-Mass Spectrometry (LC/MS). These methods provide quantitative results, allowing for precise determination if a sample is above or below the specified cutoff concentration.

8. The sample size for the training set

• Sample Size (Training Set): Not stated in the provided documents. For simple immunoassays, a "training set" in the machine learning sense is not typically used for algorithm development; rather, assay parameters are optimized during R&D using a set of characterized samples.

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

• Ground Truth (Training Set): Not detailed in the provided documents. If a "training set" was used for assay optimization, its ground truth would have been established by similar reference methods (e.g., GC/MS, LC/MS) as the test set, ensuring that the samples used for development accurately reflected known drug concentrations.

Summary of Limitations:
The provided document is a regulatory approval letter and an "Indications for Use" statement, not the detailed study report. Therefore, specific performance data, acceptance criteria, sample sizes, and detailed methodology of the validation study are not included in these pages. Such information would typically be found in the full 510(k) submission, which is not publicly available in this level of detail.

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The Ameditech ImmuTest™ hCG Pregnancy Test is an In Vitro diagnostic test for the qualitative detection of hCG in human urine to aid in the early detection of pregnancy. The sensitivity of the ImmuTest™ hCG Pregnancy Test is 25 mIU/ml hCG. This test kit is used to obtain a visual, qualitative result and is intended for professional and Over-the-Counter uses.

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1. Table of Acceptance Criteria and Reported Device Performance:

Note: The document only reported the sensitivity of the device but did not explicitly define an "acceptance criteria" against which this performance was measured within the provided text. It simply stated the device's sensitivity.

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

The provided document does not contain information regarding:

• The sample size used for the test set.
• The data provenance (e.g., country of origin of the data, retrospective or prospective).

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

The provided document does not contain information regarding:

• The number of experts used to establish the ground truth for the test set.
• The qualifications of those experts.

4. Adjudication Method for the Test Set:

The provided document does not contain information regarding the adjudication method used for the test set.

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

The provided document does not contain information indicating whether an MRMC comparative effectiveness study was done, nor any effect size of human reader improvement with or without AI assistance. This device is an in-vitro diagnostic test, not typically associated with AI assistance for human readers in the way an imaging AI might be.

6. Standalone (Algorithm Only) Performance Study:

The provided document describes the "Ameditech ImmuTest™ hCG Pregnancy Test" as a "visual, qualitative result" test. This strongly suggests it is a traditional in-vitro diagnostic assay read by a person, not an algorithm. Therefore, a standalone (algorithm only) performance study does not appear to be relevant or applicable to this device based on the information provided.

7. Type of Ground Truth Used:

The provided document does not explicitly state the type of ground truth used. For an hCG pregnancy test, the ground truth would typically be established by a reference method for hCG detection, or confirmed clinical pregnancy status.

8. Sample Size for the Training Set:

The provided document does not contain information regarding the sample size for the training set.

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

The provided document does not contain information on how the ground truth for the training set was established.

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The Ameditech ImmuTest™ Drug Screen OPIATES is an In Vitro screen test for the qualitative detection of opiate metabolites in human urine at cut-off concentration of 2000 ng/ml. This test kit is used to obtain a visual, qualitative result and is intended for professional use.

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The provided document is a 510(k) premarket notification letter from the FDA for a device called "Ameditech ImmuTest™ Drug Screen Opiates." This document does not contain the information requested regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment.

A 510(k) letter is an approval notification based on substantial equivalence to a legally marketed predicate device, not a detailing of the device's performance studies or clinical trial results. Therefore, I cannot extract the requested information from this document.

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The Ameditech ImmuTest™ Drug Screen PCP is an In Vitro screen test for the qualitative detection of Phencyclidine in human urine at cut-off concentration of 25 ng/ml. This test kit is used to obtain a visual, qualitative result and is intended for professional use.

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I am sorry, but the provided text does not contain the detailed information needed to describe the acceptance criteria and the study that proves the device meets them in the format requested. The document is an FDA 510(k) clearance letter for the Ameditech ImmuTest™ Drug Screen PCP, stating that the device is substantially equivalent to legally marketed predicate devices.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test or training sets.
• Data provenance.
• Number or qualifications of experts.
• Adjudication methods.
• Information on MRMC comparative effectiveness studies or standalone performance studies.
• Details on how ground truth was established for either test or training sets.

The relevant information in the provided document is limited to:

• Device Name: Ameditech ImmuTest™ Drug Screen PCP
• Regulatory Number: Unclassified
• Product Code: LCM
• Indications For Use: An In Vitro screen test for the qualitative detection of Phencyclidine in human urine at a cut-off concentration of 25 ng/ml. Intended for professional use to obtain a visual, qualitative result.

To provide the comprehensive answer you're looking for, I would need a different type of document, such as a summary of safety and effectiveness data (SSED), a clinical study report, or the full 510(k) submission, which would detail the performance data and testing methodologies.

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