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The Psychemedics Microplate EIA for Amphetamine is an enzyme immunoassay (EIA) for the preliminary qualitative detection of amphetamine in human head and body hair using an amphetamine calibrator at 3 ng /10 mg hair cutoff for the purpose of identifying amphetamine use. This is an in vitro diagnostic device intended exclusively for Psychemedics use only. Psychemedics has not performed an evaluation of reproducibility at different laboratories.

The Psychemedics Microplate EIA amphetamine assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas or Liquid Chromatography/Mass Spectrometry (GC/MS or LC/MS/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

The test consists of two parts; a pre-analytical hair treatment procedure (to convert the solid matrix of hair to a measurable liquid matrix) and the screening assay, the Psychemedics Microplate EIA for Amphetamine. The screening portion of the test system consists of ( 1 ) microplate wells coated with multiple antigens including methamphetamine conjugated to bovine serum albumin (BSA), monoclonal mouse anti-amphetamine, rabbit anti-mouse secondary antibody conjugated to HRP (horseradish peroxidase), substrate [3, 3', 5, 5' tetramethylbenzidine (TMB)], HCl to acidify (and stop the reaction), and wash buffer for washing the plates. Absorbance in the wells is read with a microplate reader.

Here's a breakdown of the acceptance criteria and the study details for the Psychemedics Microplate EIA for Amphetamine in Hair, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" with numerical targets in a structured table for diagnostic accuracy (e.g., sensitivity, specificity). Instead, the performance is demonstrated through various studies. The primary comparison is against LC/MS/MS as the confirmatory method. The closest we get to performance criteria are successful precision, cross-reactivity, interference, and environmental contamination studies, as well as substantial equivalence to the predicate device.

Implicit Acceptance Criteria and Reported Device Performance:

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

• Test Set Sample Size:

  • Comparison Testing (EIA vs. LC/MS/MS): 180 samples (comprising both head and body hair).
  • Precision Studies:
    • Intra-Assay: 15 replicates per level (Negative, Cutoff +/- concentrations), totaling 120 samples (8 levels * 15 replicates).
    • Inter-Assay: 75 replicates per level, totaling 600 samples (8 levels * 75 replicates).
  • Cosmetic Treatment Studies: 20 negative samples + 12 positive samples per treatment type (bleach, permanent wave, dye, relaxer, shampoo) for "before and after" comparison. This implies at least 32 distinct samples, each tested multiple times.
  • Environmental Contamination Studies:
    • Aqueous Wash: 11 samples (water-soaked) + 11 samples (saline-soaked)
    • Ethanol Wash: 10 samples (water-soaked) + 13 samples (saline-soaked)
  • Storage & Shipping Stability: 21 amphetamine-positive samples for each study (storage and shipping).
  • Cross-reactivity: MDA, d-amphetamine, PMA, Chloramphetamine, Phentermine, l-amphetamine, MDMA, PMMA, Phenylpropanolamine, Pseudoephedrine, IR, 2S Ephedrine, S,S Pseudoephedrine, Phenylethylamine, MDEA, L-methamphetamine, Ranitidine, Fenfluramine, Mephentermine, Phenmetrazine, Phendimetrazine, Metanephrin (total of 21 named), plus 140 other compounds. Each would have been tested.
  • Interference: 119 compounds.

• Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given it's a 510(k) submission to the FDA, it is expected to be from studies conducted under appropriate quality systems, likely in the US, but this is not confirmed. It appears to be prospective data collection for the performance studies described.

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

The ground truth for the comparison testing (diagnostic accuracy) and other analytical performance studies was established using LC/MS/MS (Liquid Chromatography/Mass Spectrometry/Mass Spectrometry) or GC/MS (Gas Chromatography/Mass Spectrometry) as the "preferred confirmatory method."

These methods are highly sensitive and specific analytical techniques widely considered the gold standard for drug detection and quantification. Therefore, the "experts" in establishing this ground truth are the analytical instrumentation and the laboratory personnel qualified to operate and interpret results from LC/MS/MS/GC/MS systems. No human expert consensus was used to establish the ground truth in the clinical sense, but rather the objective biochemical analysis provided by these confirmatory methods.

4. Adjudication Method for the Test Set

No human adjudication method (like 2+1 or 3+1) was explicitly mentioned. The "ground truth" was established purely by the results of the LC/MS/MS or GC/MS confirmatory methods. Discordant results were analyzed and presented. For instance, the table of discordant results shows EIA positive results where LC/MS/MS found 0 amphetamine but identified other substances like phentermine or methamphetamine, suggesting potential cross-reactivity for the EIA.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This would typically apply to scenarios where human readers interpret medical images or complex data, and the AI's role is to assist human interpretation. This device is an in vitro diagnostic (IVD) assay designed for laboratory use, yielding a preliminary qualitative result, not for direct human interpretation in the same way an imaging AI might be. Therefore, the concept of "human readers improving with AI vs. without AI assistance" does not directly apply here. The device provides a preliminary analytical result that then requires chemical confirmation (LC/MS/MS).

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

Yes, a standalone (algorithm only) performance study was done. The entire performance summary, including precision, comparison to LC/MS/MS, cross-reactivity, interference, cosmetic treatments, environmental contamination, and stability, assesses the performance of the "Psychemedics Microplate EIA for Amphetamine" assay itself, working in a laboratory setting. The results (Positive/Negative) are generated by the assay system, read by a microplate reader, without human interpretive input that would alter the primary output of the device as an "algorithm." The results are then further interpreted as "preliminary" and require confirmatory methods.

7. The Type of Ground Truth Used

The type of ground truth used was objective chemical confirmatory methods, specifically Gas or Liquid Chromatography/Double Mass Spectrometry (GC/MS or LC/MS/MS). These methods are considered the definitive analytical standard for identifying and quantifying drug substances.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" sample size or a training process in the context of machine learning or AI. This is an immunoassay (EIA) device, which is a biochemical test, not typically an AI/machine learning algorithm that requires a training set in the conventional sense. The "training" of such assay systems primarily involves establishing reagents, calibrators, controls, and protocols based on known chemical properties and optimization, rather than ingesting a large dataset of results for algorithmic learning.

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

Since this is an immunoassay and not an AI/ML algorithm, the concept of establishing ground truth for a "training set" as understood in AI development does not apply directly. The development of an immunoassay involves:

• Selection and optimization of antibodies (e.g., monoclonal mouse anti-amphetamine)
• Optimization of reagent concentrations (e.g., BSA conjugates, HRP, substrate)
• Establishing cutoff values (e.g., 3 ng/10 mg hair) through extensive analytical testing and comparison to reference methods (like LC/MS/MS) using known positive and negative samples, as well as samples with varying concentrations.
• Validation of the entire assay system to ensure it performs as intended across various parameters (precision, specificity, etc.), which is what the provided "Summary of Performance Testing" details.

Therefore, the "ground truth" during the development and validation of this EIA assay would have been established using analytically confirmed amphetamine concentrations in hair samples, verified by methods such as LC/MS/MS, to define the assay's performance characteristics and cutoff.

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The Psychemedics Microplate EIA for Oxycodone is an enzyme immunoassay (EIA) for the preliminary qualitative detection of the opiate oxycodone in human head and body hair using an oxycodone calibrator at 2 ng /10 mg hair cutoff for the purpose of identifying oxycodone use. This is an in vitro diagnostic device intended exclusively for Psychemedics use only and is not intended for sale to anyone.

The Psychemedics Microplate EIA oxycodone assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas or Liquid Chromatography/Mass Spectrometry (GC/MS or LC/MS or LC/MS/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

The test consists of two parts; a pre-analytical hair treatment procedure (to convert the solid matrix of hair to a measurable liquid matrix) and the screening assay, the Psychemedics Microplate EIA for Oxycodone. The drug is recovered from the hair using a patented method (U.S. Patent #8,084,215).The screening portion of the test system consists of (1) microplate wells coated with multiple drugs including oxycodone conjugated to bovine serum albumin (BSA) (patent pending), polyclonal rabbit anti-oxycodone, goat anti-rabbit secondary antibody conjugated to HRP (horseradish peroxidase), substrate [3, 3', 5, 5' tetramethylbenzidine (TMB)], HCl to acidify (which stops the reaction), and wash buffer for washing the plates. Absorbance in the wells is read with a microplate reader.

Acceptance Criteria and Device Performance for Psychemedics Microplate EIA for Oxycodone in Hair

The Psychemedics Microplate EIA for Oxycodone in Hair is an enzyme immunoassay for the preliminary qualitative detection of oxycodone in human head and body hair. The device's performance was evaluated through precision studies and agreement testing against LC/MS/MS confirmation.

1. Table of Acceptance Criteria and Reported Device Performance

The direct acceptance criteria for the device are not explicitly stated as numerical targets in the provided document. However, the performance is reported in terms of precision (intra-assay and inter-assay agreement at various concentrations relative to the cutoff) and agreement with the confirmatory method (LC/MS/MS). The implied acceptance criteria are high agreement percentages for both positive and negative samples around the cutoff.

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

• Test Set Sample Size for Agreement Testing: 161 samples.
• Data Provenance: The document does not explicitly state the country of origin. However, given the submission is to the U.S. FDA, it is likely the data was collected in the U.S. The study involved subjects aged 19-67 years, 92 males and 69 females, various hair colors (82 black, 74 brown, 5 grey), and diverse ethnicities (79 Caucasian, 24 African-American, 34 Hispanic, 24 Asian). It included 134 head hair samples and 27 body hair samples. The study appears to be prospective in nature, as samples were tested in parallel by the EIA and LC/MS/MS, and specific demographic and sample characteristics were recorded for this study. The precision studies involved spiking negative hair samples.

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

• Number of Experts: Not applicable in the traditional sense for an analytical device.
• Qualifications of Experts: The ground truth for the device's performance was established using LC/MS/MS (Liquid Chromatography/Mass Spectrometry/Mass Spectrometry), which is described as the "preferred confirmatory method" for drug testing. This is an objective, instrumental analytical technique, not reliant on human expert interpretation of images or clinical findings. The validation of the LC/MS/MS method itself would have been performed by qualified analytical chemists or toxicologists in a laboratory setting.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The comparison was made between the preliminary results of the EIA and the objective, quantitative results of LC/MS/MS. There was no human adjudication process described between different readers or interpretations for the test set.

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

• No Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done. This device is an analytical laboratory assay, not an imaging device or one requiring human interpretation for its primary output. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this type of device.

6. If a Standalone Study Was Done

• Yes, a standalone performance study was done for the Psychemedics Microplate EIA for Oxycodone. The "Agreement Testing" section directly details the performance of the EIA device alone (without human interpretation beyond reading the microplate reader output) against the LC/MS/MS ground truth. The agreement data clearly shows the algorithm's performance in categorizing samples as positive or negative based on the prescribed cutoff.

7. The Type of Ground Truth Used

• The primary ground truth used was LC/MS/MS (Liquid Chromatography/Mass Spectrometry/Mass Spectrometry) confirmation. This is an objective, quantitative analytical method considered the gold standard for confirming the presence and concentration of drugs in biological samples.

8. The Sample Size for the Training Set

• The document does not provide information on a specific training set size. The device is an immunoassay kit, and such kits are typically developed and optimized through iterative chemical and biological experimentation, rather than being "trained" in the machine learning sense on a large dataset. The studies described (precision, agreement, cross-reactivity, interference) are validation studies for the finalized assay.

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

• Since there is no explicit mention of a training set in the context of machine learning, this question is not directly applicable. For the development and optimization of the immunoassay, the "ground truth" for calibrator and control solutions would be established by preparing them from certified standards and validating their concentrations using reference analytical methods, likely including LC/MS/MS.

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The Psychemedics Microplate EIA for Cocaine is an enzyme immunoassay (EIA) for the preliminary qualitative detection of cocaine in human head and body hair samples using a cocaine calibrator at 5 ng /10 mg hair cutoff for the purpose of identifying cocaine use. This product is intended exclusively for in-house professional use only and not for sale to anyone.

The Psychemedics EIA Cocaine Assay provides only a preliminary analytical test result. To obtain a quantitative analytical result or to confirm positive results, a more specific alternate chemical method (e.g. GC/MS) must be used. Clinical consideration and professional judgment should be applied to the interpretation of any drug-of-abuse test result.

The test consists of two parts; a pre-analytical hair treatment procedure (to convert the solid matrix of hair to a measurable liquid matrix) and the screening assay, the Psychemedics Microplate EIA for Cocaine. The drug is recovered from the hair using a patented method (U.S. Patent #8,084,215). The screening portion of the test system consists of (1) microplate wells coated with multiple drugs including benzoylecgonine conjugated to bovine serum albumin (BSA) (patent pending), monoclonal mouse anti-cocaine, goat anti-mouse secondary antibody conjugated to HRP (horseradish peroxidase), substrate [3, 3', 5, 5' tetramethylbenzidine (TMB)], HCl to acidify the final reaction, and wash buffer for washing the plates. Absorbance in the wells is read with a microplate reader.

Acceptance Criteria and Study for Psychemedics Microplate EIA for Cocaine in Hair

The Psychemedics Microplate EIA for Cocaine in Hair is an enzyme immunoassay (EIA) for the preliminary qualitative detection of cocaine and its metabolites in human head and body hair. The device's performance was evaluated against a predicate device (Psychemedics Cocaine Assay, K010868) and confirmed by LC/MS/MS (liquid chromatography/mass spectrometry/mass spectrometry).

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state pre-defined acceptance criteria for the accuracy of the new device relative to the predicate or LC/MS/MS. However, the study aims to demonstrate "substantial equivalence" to the predicate and "substantially equivalent" results to LC/MS/MS. Based on the presented data, the implicit acceptance criteria appear to be:

• High agreement with the predicate device.
• High agreement with LC/MS/MS for confirmed samples.
• No significant impact of cosmetic treatments on negative or positive samples.
• Effective wash procedure to mitigate external contamination.
• Stability of calibrator and control solutions.
• Cross-reactivity within acceptable limits for related compounds, and minimal to no cross-reactivity or interference from other common compounds.
• Equivalent recovery to the predicate device.

Here's a summary of the reported device performance against these implicit criteria:

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

• Test Set Sample Size:

  • Agreement Testing: 425 hair samples were used for comparison between the predicate device and the new EIA.
  • LC/MS/MS Confirmation: 256 of the 425 samples were further confirmed by LC/MS/MS.
  • Cosmetic Treatment Study: 20 negative hair samples per treatment type (5 types = 100 samples), and 12 positive hair samples per treatment type (5 types = 60 samples).
  • Contamination Study: 8 hair samples per contamination method (water and saline = 16 samples).

• Data Provenance: The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. Given the nature of a 510(k) submission for a diagnostic device, the studies are typically conducted in a controlled laboratory environment using collected human samples, implying real-world (prospective or retrospectively collected and stored) human hair samples. The samples included both head and body hair (15.8% were body hair samples).

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

• The ground truth for the agreement and confirmation studies was established by LC/MS/MS, which is a highly specific and quantitative analytical chemical method, considered the "gold standard" for drug confirmation in forensic toxicology.
• No human "experts" in the sense of clinicians or radiologists are mentioned as establishing the ground truth for the test set results. The ground truth refers to the analytical confirmation by LC/MS/MS, performed by trained laboratory personnel.

4. Adjudication Method for the Test Set

• For the agreement testing, discrepancies between the new EIA device and the predicate RIA device (<1% of samples) were adjudicated by LC/MS/MS. The document states, "The samples were negative by LC/MS/MS, demonstrating that the EIA negative results, although discordant with the predicate, are correct." This indicates that LC/MS/MS served as the ultimate adjudicator for discordant results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No. This product is an in-vitro diagnostic (IVD) assay, not an imaging device for human interpretation. Therefore, a multi-reader, multi-case comparative effectiveness study involving human readers is not applicable. The device's performance is determined by its analytical accuracy against a gold standard (LC/MS/MS), not by human interpretation improvement.

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

• Yes. The primary studies presented (Agreement Testing, LC/MS/MS Confirmation, Cosmetic Treatment, Contamination, Cross-reactivity, and Recovery) all demonstrate the standalone performance of the Psychemedics Microplate EIA for Cocaine in Hair. The output is a preliminary qualitative result (positive/negative based on cutoff), without direct "human-in-the-loop" interpretation for the initial screening result itself. The "human-in-the-loop" aspect comes in the professional judgment for clinical interpretation of any drug-of-abuse test result and the requirement for confirmation by a more specific method for positive preliminary results.

7. The Type of Ground Truth Used

• The primary ground truth used for validating the device's accuracy is LC/MS/MS (Liquid Chromatography/Mass Spectrometry/Mass Spectrometry). This is a highly sensitive and specific analytical method for identifying and quantitating substances.
• For the agreement study, the predicate device (Psychemedics Cocaine Assay, K010868) also served as an initial comparison point, though LC/MS/MS was used to resolve discrepancies.

8. The Sample Size for the Training Set

• The document does not explicitly state the sample size for a training set. For an IVD assay like this, development typically involves internal validation and optimization, but the 510(k) summary focuses on the performance studies used for regulatory submission. It is common for the public summary to detail testing data rather than development/training data for such devices.

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

• As the document does not explicitly mention a "training set" in the context of machine learning or AI models, it also does not describe how the ground truth for a training set was established. For an immunoassay, the "training" involves optimizing reagents, protocols, and cutoff values, likely guided by samples with known cocaine concentrations confirmed by methods like GC/MS or LC/MS/MS during the assay development phase.

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The Psychemedics Microplate EIA for Opiates is an enzyme immunoassay (EIA) for the preliminary qualitative detection of opiates in human head and body hair using a morphine calibrator at 2 ng /10 mg hair cutoff for the purpose of identifying opiate use. This is an in vitro diagnostic device intended exclusively for Psychemedics use only and is not intended for sale to anyone.

The Psychemedics Microplate EIA opiate assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas or Liquid Chromatography/Mass Spectrometry (GC/MS or LC/MS/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

The test consists of two parts; a pre-analytical hair treatment procedure (to convert the solid matrix of hair to a measurable liquid matrix) and the screening assay, the Psychemedics Microplate EIA for Opiates. The drug is recovered from the hair using a patented method (U.S. Patent #8,084.215).The screening portion of the test system consists of (1) microplate wells coated with multiple drugs including morphine conjugated to bovine serum albumin (BSA) (patent pending), polyclonal sheep anti-morphine, rabbit anti-goat secondary antibody conjugated to HRP (horseradish peroxidase), substrate [3, 3', 5, 5' tetramethylbenzidine (TMB)}, HCl to acidify the final reaction, and wash buffer for washing the plates. Absorbance in the wells is read with a microplate reader.

The provided text describes the performance testing of the Psychemedics Microplate EIA for Opiates in Hair. However, it does not explicitly state "acceptance criteria" as a separate, pre-defined set of metrics. Instead, the study aims to demonstrate substantial equivalence to a predicate device (Psychemedics RIA Assay for Opiates) and correlation with a confirmatory method (LC/MS/MS).

The "acceptance criteria" can be inferred from the reported performance results, particularly the low discordance with the predicate device and the high agreement with LC/MS/MS, especially for confirmed positive and negative samples.

Here's an analysis of the requested information based on the provided text:

Acceptance Criteria and Reported Device Performance

Inferred Acceptance Criteria:

1. Low discordance with predicate device (RIA Assay for Opiates): The device should show strong agreement with the established predicate method.
2. High agreement with LC/MS/MS confirmation: For definitive positive and negative cases, the EIA result should align with the LC/MS/MS results.
3. Robustness to cosmetic treatments: Cosmetic treatments should not significantly alter the test results for both negative and positive samples.
4. Effective contamination control: The wash procedure should effectively remove external contamination, preventing false positives.
5. Limited cross-reactivity and no interference: The assay should be specific to opiates and not significantly affected by common interfering substances.

Reported Device Performance:

Study Details:

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

   • Agreement Testing: 383 head hair samples and 90 body hair samples (total 473 hair samples).
   • LC/MS/MS Confirmation: 253 of the above samples were confirmed by LC/MS/MS.
   • Cosmetic Treatments (Negative): 20 opiate-negative hair samples per treatment type (bleach, permanent wave, dye, relaxer, shampoo) for a total of 100 samples.
   • Cosmetic Treatments (Positive): 12 opiate-positive hair samples per treatment type (bleach, permanent wave, dye, relaxer, shampoo) for a total of 60 samples.
   • Contamination Study: 8 hair samples soaked in morphine/water, 8 hair samples soaked in morphine/saline.
   • Data Provenance: Not explicitly stated, but typically these samples would be collected in a controlled or clinical environment for regulatory submissions. Given the context of a US submission, it's highly likely to be originating from the US. The type seems to be retrospective as they are described as "samples" rather than "patients undergoing a diagnostic pathway".

2. 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 primarily established by LC/MS/MS (Liquid Chromatography/Mass Spectrometry/Mass Spectrometry), which is described as the "preferred confirmatory method." LC/MS/MS results are considered the gold standard for drug detection in hair, not expert consensus. Therefore, no human experts were explicitly used for establishing the primary ground truth.

3. Adjudication method for the test set:

   • Not applicable in the traditional sense, as the ground truth was established by LC/MS/MS, a quantitative analytical method, not human interpretation requiring adjudication. For discrepancies between the EIA and RIA, the LC/MS/MS method was used as the arbiter: "The samples were negative by LC/MS/MS, demonstrating that the EIA negative results, although discordant with the predicate, are correct."

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 done. This device is an in vitro diagnostic assay, not an AI-assisted diagnostic tool that involves human readers interpreting images or data for improvement. The study focuses on the analytical performance of the assay itself.

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

   • Yes, this study represents a standalone performance evaluation of the Psychemedics Microplate EIA for Opiates. The "algorithm" here refers to the EIA assay's chemical and optical detection mechanism. The performance is assessed purely on its analytical results against a gold standard (LC/MS/MS) and a predicate device (RIA), without human interpretation influencing the primary outcome or a human-in-the-loop component for improved performance. The device provides "preliminary analytical test results," which are then confirmed by other chemical methods.

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

   • The primary ground truth used was LC/MS/MS (Liquid Chromatography/Mass Spectrometry/Mass Spectrometry), which is a highly sensitive and specific chemical method considered the "gold standard" for confirming the presence and concentration of drugs in biological samples like hair.

7. The sample size for the training set:

   • The document does not provide information about a separate training set. The data presented appears to be from a validation or test set to demonstrate the device's performance. For in vitro diagnostic assays, the "training" (development and optimization) phase often involves internal experiments and is generally not documented in the same way as a machine learning model's training set in regulatory submissions.

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

   • As no training set is explicitly mentioned or described, this information is not available in the provided text.

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The Psychemedics Microplate EIA for Cannabinoids in Hair is an enzyme immunoassay (EIA) for the preliminary qualitative detection of cannabinoids in human head and body hair samples using a 11-nor-9-Carboxy- Δ'-THC calibrator at 10 pg/10 mg hair cutoff for the purpose of identifying marijuana use. This is an in vitro diagnostic device intended exclusively for Psychemedics use only and is not intended for sale to anyone.

The Psychemedics Chemiluminscent Microplate EIA for Cannabinoids assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry/Mass Spectrometry (GC/MS/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

The EIA screening test consists of two parts; a pre-analytical hair treatment procedure to recover the cannabinoids from the hair and the screening assay, the Psychemedics Chemiluminescent EIA for Cannabinoids in Hair. The device comprises a white microplate coated with the antigen (11-nor-9-carboxy-delta-8-tetrahydrocannabinol) conjugated to BSA, polyclonal rabbit anticannabinoid antibody, goat anti-rabbit secondary antibody conjugated to HRP (horseradish peroxidase), a chemiluminescent substrate, and platewashing buffer.

Here's a breakdown of the acceptance criteria and the study details for the Psychemedics Chemiluminescent Microplate EIA for Cannabinoids in Hair, based on the provided 510(k) summary:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by demonstrating substantial equivalence to the predicate device and showing agreement with the confirmatory method (GC/MS/MS). While explicit percentage targets for sensitivity and specificity are not directly stated as "acceptance criteria," the performance in the agreement testing (both with the predicate and GC/MS/MS) is presented to show the device meets the regulatory requirements for substantial equivalence.

Study Details

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

• Agreement Testing with Predicate Device:
  • Sample Size: 610 hair samples (18.9% body hair, remainder head hair).
  • Data Provenance: Not explicitly stated, but given it's Psychemedics' own product and existing predicate, it's likely internal laboratory data, possibly collected retrospectively from their testing services. No country of origin is specified.
• Agreement Testing with GC/MS/MS:
  • Sample Size: 318 of the 610 samples after preliminary testing were further confirmed by LC/MS/MS.
  • Data Provenance: Not explicitly stated.
• Cosmetic Treatment Studies:
  • Negative Samples: 20 cannabinoid-negative hair samples (10 per brand for each cosmetic type).
  • Positive Samples: 12 cannabinoid-positive hair samples (6 per brand for each cosmetic type).
  • Data Provenance: Not explicitly stated.
• Contamination Study:
  • Sample Size: 12 hair samples (various colors, including red).
  • Data Provenance: Lab-generated (experimentally contaminated with marijuana smoke).

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

• Agreement with Predicate Device: The "ground truth" for this comparison was the result from the predicate device (Psychemedics Marijuana Screening and Confirmatory Test System, using RIA and GC/MS/MS). This implies the ground truth was established by the predicate device's methodology, which includes laboratory analysis. No individual human experts are described as establishing this particular ground truth, but rather the established method.
• Agreement with Confirmatory Method (GC/MS/MS): The ground truth for this segment of the study was established by LC/MS/MS (Liquid Chromatography/Mass Spectrometry/Mass Spectrometry) which is stated elsewhere to be GC/MS/MS (Gas Chromatography/Mass Spectrometry/Mass Spectrometry), the "preferred confirmatory method" for drugs of abuse testing. This is a highly accurate analytical chemical method. No human experts are described as manually interpreting or establishing this ground truth, as it's an objective chemical measurement.
• Cosmetic Treatment and Contamination Studies: The ground truth for these was either inferred from known negative/positive status of samples (for cosmetic treatments) or the known contamination event and the subsequent GC/MS/MS analysis (for the contamination study). Again, no specific human experts are detailed for establishing this ground truth, it's based on analytical results.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method involving human experts for resolving disagreements. The comparisons rely on:

• Direct comparison of the investigational device's EIA results against the predicate device's RIA results for agreement.
• Direct comparison of the investigational device's EIA results against the objective chemical analysis results from LC/MS/MS (or GC/MS/MS) as the definitive ground truth for drug presence.

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

No. This is an in vitro diagnostic device (EIA assay) for preliminary qualitative detection, not an imaging device or one that relies on human interpretation for its primary output. Therefore, an MRMC study is not applicable or described.

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

Yes, the performance data presented (precision, agreement with predicate, agreement with GC/MS/MS, cosmetic treatment, contamination, cross-reactivity, interference, stability, recovery) are all reflective of the standalone performance of the Psychemedics Chemiluminescent Microplate EIA for Cannabinoids in Hair. The device itself performs the assay, and the results are read by a microplate reader. While a human initiates the test and interprets the final result in the context of a cutoff, the performance metrics reported are for the assay system's analytical capabilities without human interpretative intervention in the measurement itself. The device provides "only a preliminary analytical test result," emphasizing its standalone nature as a screening tool.

7. The Type of Ground Truth Used

The primary ground truth used is objective chemical analysis:

• For agreement studies, GC/MS/MS (Gas Chromatography/Mass Spectrometry/Mass Spectrometry) or LC/MS/MS (Liquid Chromatography/Mass Spectrometry/Mass Spectrometry) is explicitly stated as the preferred confirmatory method and was used to confirm 318 samples.
• The predicate device itself also uses mass spectrometry for confirmation as part of its "bipartite device." This implies an analytical, rather than expert consensus or pathology-based, ground truth.

8. The Sample Size for the Training Set

The document does not provide information about a "training set" for the device. As an immunoassay (EIA), this device likely uses a predetermined set of reagents and a fixed protocol, rather than a machine learning algorithm that requires a traditional training set. The development of the assay itself would have involved extensive R&D, but the data presented here are for validation and performance testing of the finalized assay.

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

Since no explicit training set for an algorithm is mentioned, this question is not directly applicable. The assay's development and optimization would have relied on known positive and negative samples, with their true status confirmed by robust analytical methods like GC/MS/MS.

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The Psychemedics Microplate EIA for Methamphetamine is an enzyme immunoassay (EIA) for the preliminary qualitative detection of methamphetamine in human head and body hair samples using a methamphetamine calibrator at 5 ng /10 mg hair cutoff for the purpose of identifying methamphetamine use. This product is intended exclusively for inhouse professional use only and is not for sale to anyone.

The Psychemedics Microplate EIA for Methamphetamine in Hair provides only a preliminary analytical test result. To confirm a presumptive screen positive result, a more specific alternate chemical method such as LC/MS/MS (liquid chromatography/mass spectrometry/mass spectrometry) must be used. Clinical consideration and professional judgment must be applied to the interpretation of any drug-of-abuse test result.

The test consists of two parts: a pre-analytical hair treatment procedure (to convert the solid matrix of hair to a measurable liquid matrix) and the screening assay, the Psychemedics Microplate EIA for Methamphetamine. The drug is recovered from the hair using a patented method (U.S. Patent #8,084,215).The screening portion of the test system consists of (1) microplate wells coated with multiple drugs including methamphetamine conjugated to bovine serum albumin (BSA) (patent pending), polyclonal sheep anti-methamphetamine, rabbit anti-goat secondary antibody conjugated to HRP (horseradish peroxidase), substrate [3, 3', 5, 5' tetramethylbenzidine (TMB)], HCI to acidify the final reaction, and wash buffer for washing the plates. Absorbance in the wells is read with a microplate reader.

The provided document describes the Psychemedics Microplate EIA for Methamphetamine in Hair, an enzyme immunoassay (EIA) for the preliminary qualitative detection of methamphetamine in human hair samples. The study aims to demonstrate substantial equivalence to a predicate device (Psychemedics Methamphetamine and MDMA Assay, K011185) and alignment with LC/MS/MS results.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in a formal table format. However, it presents performance data that implies the criteria for the device to be considered substantially equivalent and perform adequately. Based on the provided "Agreement Testing" section, we can infer the following:

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

• Agreement Testing (vs. Predicate): 536 hair samples.
  • 16% (approximately 86 samples) were body hair samples; the remainder were head hair.
  • Data provenance is not explicitly stated (e.g., country of origin, retrospective/prospective). However, it's implied to be real-world human hair samples.
• Agreement Testing (vs. LC/MS/MS): 213 of the 536 samples.
• Precision Studies:
  • Intra-Assay: 15 replicates per level (negative: 4 levels, positive: 4 levels). Total 120 tests.
  • Inter-Assay: 75 replicates per level (negative: 4 levels, positive: 4 levels). Total 600 tests.
• Cosmetic Treatment Study:
  • 20 methamphetamine-negative samples per cosmetic treatment type (5 types = 100 samples).
  • 12 methamphetamine-positive samples per cosmetic treatment type (5 types = 60 samples).
• Contamination Study: The number of hair samples used for the contamination study is not explicitly stated, but it describes soaking hair in methamphetamine solutions and then washing them.
• Cross-reactivity and Interference Studies:
  • Cross-reactivity: 5 compounds that cross-reacted, plus 67 other compounds showing no cross-reactivity (total 72 compounds).
  • Interference: 128 compounds tested.

The data provenance (country of origin, retrospective/prospective) is not explicitly stated in the provided text for any of the studies.

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

• The ground truth in this submission is established through:

  • Predicate Device (RIA): The Psychemedics Methamphetamine and MDMA Assay, K011185. This is another diagnostic test, itself validated.
  • LC/MS/MS (Liquid Chromatography/Mass Spectrometry/Mass Spectrometry): This is described as a "more specific alternate chemical method" and is used for confirmation. This technique is typically considered the gold standard for drug quantification.
  • Clinical consideration and professional judgment: The document notes that these "must be applied to the interpretation of any drug-of-abuse test result."

• No "experts" in the traditional sense of human readers/interpreters (e.g., radiologists) were used to establish ground truth. The ground truth is based on the analytical results of the predicate device and, more definitively, the LC/MS/MS method. The qualifications of individuals performing these LC/MS/MS confirmations are not detailed, but it's a standard laboratory practice requiring trained analytical chemists.

4. Adjudication Method for the Test Set

Since the ground truth is established by objective analytical methods (predicate device, and primarily LC/MS/MS), there is no adjudication method by multiple human experts (e.g., 2+1, 3+1). The LC/MS/MS results serve as the definitive ground truth for the subsets of samples that underwent that testing.

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

There was no MRMC comparative effectiveness study performed. This device is an immunoassay, and its output is an analytical result (positive/negative based on a cutoff, or quantitative for confirmation) rather than an image or complex data requiring interpretation by multiple human readers. Therefore, the concept of "human readers improving with AI vs. without AI assistance" does not apply here.

6. Standalone (Algorithm Only) Performance

Yes, the studies reported are for the standalone performance of the Psychemedics Microplate EIA for Methamphetamine in Hair. The performance metrics (precision, agreement with predicate/LC/MS/MS, cosmetic treatment, contamination, cross-reactivity, interference, recovery, stability) all describe the direct output of the assay itself, without human-in-the-loop assistance in the interpretation of the primary result (detection of methamphetamine).

7. Type of Ground Truth Used

The primary ground truth used is LC/MS/MS (Liquid Chromatography/Mass Spectrometry/Mass Spectrometry), which is a gold-standard analytical confirmation method for drug testing. The predicate device (RIA) also served as a comparative ground truth to demonstrate substantial equivalence, but LC/MS/MS was utilized to confirm the accuracy of discordant results.

8. Sample Size for the Training Set

The document does not provide information on the sample size used for a training set. This is an immunoassay, which typically involves pre-developed reagents and protocols rather than a machine learning algorithm requiring a "training set" for model development. The precision and agreement studies are performance validation tests, not training data.

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

As there is no mention of a "training set" in the context of a machine learning algorithm, this question is not applicable based on the provided text. The device is a chemical assay, not an AI/ML diagnostic.

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The Psychemedics Microplate EIA for Phencyclidine is an enzyme immunoassay (EIA) for the preliminary qualitative detection of phencyclidine in human head and body hair samples using a phencyclidine calibrator at 3 ng /10 mg hair cutoff for the purpose of identifying phencyclidine use. This is an in vitro diagnostic device intended exclusively for Psychemedics use only and is not intended for sale to anyone. The Psychemedics EIA Phencyclidine Assay provides only a preliminary analytical test result. To obtain a quantitative analytical result or to confirm positive results, a more specific alternate chemical method (e.g. GC/MS) must be used. Clinical consideration and professional judgment should be applied to the interpretation of any drug-of-abuse test result.

The test consists of two parts; a pre-analytical hair treatment procedure (to convert the solid matrix of hair to a measurable liquid matrix) and the screening assay, the Psychemedics Microplate EIA for Phencyclidine. The drug is recovered from the hair using a patented method (U.S. Patent #8.084.215).The screening portion of the test system consists of (1) microplate wells coated with multiple drugs including phencyclidine conjugated to bovine serum albumin (BSA) (patent pending), polyclonal rabbit anti-phencyclidine, goat anti-rabbit secondary antibody conjugated to HRP (horseradish peroxidase), substrate [3, 3', 5, 5' tetramethylbenzidine (TMB)], HCl to acidify the final reaction, and wash buffer for washing the plates. Absorbance in the wells is read with a microplate reader.

Here's a breakdown of the acceptance criteria and the study details for the Psychemedics Microplate EIA for Phencyclidine in Hair, based on the provided 510(k) summary:

Acceptance Criteria and Reported Device Performance

Study Details

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

   • Agreement Testing (compared to GC/MS):
     • Total samples: 229 samples (140 negative, 24 below cutoff, 15 between cutoff and +100% of cutoff, 46 >100% of cutoff).
     • Body hair samples: 15% of the total samples.
   • Agreement Testing (compared to Predicate Device):
     • Total samples: An additional 224 negative samples were compared to the predicate. (There appear to be missing values/errors in the provided table for positive comparisons).
   • Precision Studies:
     • Intra-Assay: 15 replicates per concentration level (total 8 levels tested).
     • Inter-Assay: 75 replicates per concentration level (total 8 levels tested).
   • Cosmetic Treatment Studies:
     • Negative samples: 100 samples (20 per treatment type: bleach, permanent wave, dye, relaxer, shampoo; 10 samples per brand for each treatment).
     • Positive samples: 60 samples (12 per treatment type: bleach, permanent wave, dye, relaxer, shampoo; 6 samples per brand for each treatment).
   • Contamination Study: 16 hair samples (8 soaked in water-PCP, 8 soaked in saline-PCP).
   • Cross-reactivity and Interference Studies: 66 compounds for cross-reactivity (2 showed cross-reactivity, 64 did not), and 128 compounds for interference.
   • Data Provenance: Not explicitly stated, but the submission is from a US company (Psychemedics Corporation, Culver City, CA). The context of a 510(k) submission generally implies prospective collection for performance evaluation or retrospective analysis of samples typical for the intended use.
   • Retrospective/Prospective: Not explicitly stated. The nature of the studies (e.g., controlled spiking for precision, controlled cosmetic treatments, contamination studies) suggests a mix of controlled experimental prospective studies and likely retrospective collection of clinical samples for agreement testing.

2. 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 (primarily for agreement studies) was established by GC/MS (Gas Chromatography/Mass Spectrometry), which is an analytical chemical method, not human expert consensus. GC/MS is considered the gold standard for confirming drug presence and concentration in forensic and clinical toxicology. Therefore, no human experts were used to establish this analytical ground truth.

3. Adjudication method for the test set:

   • Not applicable/mentioned for the analytical ground truth (GC/MS). For the comparison between the new device and the predicate, there's no mention of an adjudication process; it's a direct comparison of results.

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:

   • This is an in vitro diagnostic (IVD) device, specifically an immunoassay for drug detection. It does not involve human readers interpreting results in the way an imaging AI typically would. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable to this device.

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

   • Yes, the performance studies described (Agreement with GC/MS, Precision, Cosmetic Treatment Effects, Contamination Effects, Cross-reactivity) represent the standalone performance of the Psychemedics Microplate EIA for Phencyclidine. The device provides a preliminary analytical test result. While a human is involved in running the assay and interpreting the preliminary qualitative result, the performance data presented are inherent to the assay's chemical and enzymatic reactions (the "algorithm" in a broad sense for IVDs). However, it's crucial to note the stated intended use that positive results must be confirmed by GC/MS, implying a human-in-the-loop for definitive diagnosis, but the reported performance metrics are for the assay itself.

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

   • Analytical Ground Truth: GC/MS (Gas Chromatography/Mass Spectrometry) was used as the ground truth for confirming the presence and concentration of phencyclidine in hair samples. This is a highly accurate chemical method, considered the definitive standard for such measurements.

7. The sample size for the training set:

   • The document describes device performance studies for a submitted medical device (Psychemedics Microplate EIA). These types of submissions typically focus on validation studies (test sets) rather than detailing the full development and "training" of the assay, especially since it's a traditional immunoassay, not a machine learning algorithm in the modern sense. Therefore, no specific "training set" sample size is mentioned or applicable in the context of this traditional immunoassay device. The assay design and formulation would have been optimized during development, but this wouldn't be referred to as a "training set" in the way it is for AI.

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

   • As stated above, the concept of a "training set" and associated "ground truth" doesn't directly apply here as it would for an AI/ML-based device. The assay components and their interactions (e.g., antibodies, substrates, reagents) are designed based on known biochemical principles and then validated through performance testing against established analytical methods like GC/MS and predicate devices.

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