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The QMS® Everolimus Assay is intended for the quantitative determination of Everolimus in human whole blood on automated clinical chemistry analyzers. The results obtained are used as an aid in the management of kidney and liver transplant patients receiving Everolimus therapy. This in vitro diagnostic device is intended for clinical laboratory use only.

The QMS® Everolimus Assay consists of separately packaged reagents (R1, R2, and Precipitation Reagent) with the following contents and configurations.
R1 Antibody Reagent: <1.0% Anti-Everolimus polyclonal antibody (rabbit) in a buffer as stabilizer and <0.09% sodium azide as preservative. 1 x 22 mL
R2 Microparticle Reagent: <0.6% Everolimus-coated microparticles in buffer containing <0.05% sodium azide as preservative. 1 x 8 mL
Precipitation Reagent: Precipitating reagent, and <0.09% sodium azide as preservative. 1 x 8 mL
The reagents are supplied ready-to-use in liquid form in plastic HDPE bottles, for storage at 2 to 8°C. The reagent set is sufficient for 100 tests.

Here's an analysis of the acceptance criteria and study findings for the Thermo Scientific QMS® Everolimus Assay, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: The document does not explicitly state the total number of samples used for the "Method Comparison" study or for other performance tests like precision and linearity. It mentions "Everolimus samples were tested for precision" and "Samples were tested in the QMS® Everolimus Assay and compared to LC/MS."
• Data Provenance: The document does not provide details on the country of origin of the data or whether the data was retrospective or prospective.

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

This section is not applicable as the device is an in-vitro diagnostic assay for quantitative determination of a drug in human whole blood. The "ground truth" for method comparison and analytical performance is established by comparison to a reference method (LC/MS) or by known concentrations of the analyte in manufactured samples (e.g., calibrators, controls). It does not involve human expert interpretation of images or clinical data.

4. Adjudication method for the test set

This is not applicable for this type of in-vitro diagnostic device. Analytical studies like method comparison and precision do not typically involve adjudication by experts.

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

This is not applicable. This device is an automated in-vitro diagnostic (IVD) assay, not an AI-powered diagnostic tool requiring human interpretation or an MRMC study.

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

This is essentially how the device operates. The QMS® Everolimus Assay is an automated clinical chemistry assay that provides quantitative results. Its performance (analytical sensitivity, precision, method comparison) is evaluated in a standalone manner, meaning the assay itself generates the readings, which are then used by clinicians for patient management. There isn't a "human-in-the-loop" for the direct measurement process itself, although clinicians interpret the results.

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

The ground truth for the analytical performance studies appears to be:

• LC/MS (Liquid Chromatography/Mass Spectrometry): For the "Method Comparison" study, LC/MS served as the reference method for determining Everolimus concentrations.
• Known Concentrations: For studies like Analytical Sensitivity (LDD), Functional Sensitivity (LOQ), Precision, and Dilution Recovery, the ground truth would be based on precisely prepared samples with known concentrations of Everolimus (e.g., calibrators, controls, spiked samples).

8. The sample size for the training set

This information is not provided in the summary. For an IVD assay like this, there isn't a traditional "training set" in the sense of machine learning algorithms. Instead, assay development involves extensive testing and optimization using various formulations and spiked samples to establish performance characteristics, rather than a distinct training/test split of clinical data.

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

As noted above, a distinct "training set" with ground truth in the machine learning sense is not explicitly described or typically applicable for IVD assay development. The "ground truth" during development and optimization would involve using:

• Reference standards: Pure Everolimus used to create calibrators and controls with known concentrations.
• LC/MS analysis: As a highly accurate reference method to verify concentrations in samples during development.
• Spiked samples: Whole blood samples spiked with known amounts of Everolimus to assess recovery and other analytical parameters.

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The QMS® Tacrolimus Immunoassay is intended for the quantitative determination of tacrolimus in human whole blood on automated clinical chemistry analyzers. The results obtained are used as an aid in the management of kidney, liver, and heart transplant patients receiving tacrolimus therapy. This in vitro diagnostic device is intended for clinical laboratory use only.

The QMS® Tacrolimus Calibrator set is intended for use in calibration of the QMS® Tacrolimus Immunoassay.

The QMS® Tacrolimus Immunoassay consists of separately packaged reagents (Reagent 1, Reagent 2 and Extraction Reagent) and calibrators (Calibrator A, B, C, D, E, and F).

Reagent 1 (Antibody Reagent): <1.0% Anti-Tacrolimus monoclonal antibody (rabbit) in a buffer as stabilizer and <0.09% sodium azide as preservative. Configuration: 1 x 18 mL.
Reagent 2 (Microparticle Reagent): <0.3% Tacrolimus-coated microparticles in buffer containing <0.09% sodium azide as preservative. Configuration: 1 x 12 mL.
Extraction Reagent: 300 mM Zinc Sulfate and <0.09% sodium azide as preservative. Configuration: 1 x 50 mL.

QMS® Tacrolimus Reagents are provided ready-to-use in liquid form and are to be stored at 2 to 8°C until the expiration date on the label.

Calibrator Level, Target Concentration (ng/mL), Configuration:
Calibrator A, 0.0, 1 x 4 mL
Calibrator B, 2.0, 1 x 2 mL
Calibrator C, 5.0, 1 x 2 mL
Calibrator D, 10.0, 1 x 2 mL
Calibrator E, 20.0, 1 x 2 mL
Calibrator F, 30.0, 1 x 2 mL

The QMS® Tacrolimus Calibrator kit is provided separately and packaged in amber glass bottles in a rectangular cardboard box with a 6-bottle divider. The calibrators are provided in liquid form and are to be stored at -20℃ ± 5℃ until the expiration date on the label. They are ready-to-use upon thawing.

Here's an analysis of the acceptance criteria and study information for the QMS® Tacrolimus Immunoassay, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document implies acceptance criteria based on standard laboratory practices for in vitro diagnostics. Specific numerical thresholds for "high correlation" or "acceptable level" for parameters like comparison studies and specificity are not explicitly stated as acceptance criteria but are inferred from the reported results being presented as evidence of performance.

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

The document does not explicitly state the specific number of samples used for the "test set" for each performance study. It mentions "samples were tested" implying internal validation.

• Functional Sensitivity (LOQ): Not specified.
• Precision: Not specified.
• Dilution Recovery: Not specified.
• Spike Recovery: Not specified.
• Method Comparison: Not specified. It indicates "samples were tested" and compared to LC-MS/MS and the predicate device.
• Specificity: Not specified. Indicated "studies were conducted for available major metabolites... medications routinely co-administered... and other over-the-counter drugs."
• Interfering Substances: Not specified. Indicated "endogenous substances... were tested."
• Reagent Stability: Not specified.
• Calibrator Stability: Not specified.

Data Provenance: The studies appear to be internal validation studies conducted by Thermo Fisher Scientific. The document does not specify country of origin for the data, nor does it explicitly state whether the data was retrospective or prospective, though it's typically prospective for performance validation.

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

This information is not applicable to this type of device (immunoassay). The "ground truth" for an immunoassay is established by reference methods or known concentrations, not by expert interpretation of images or other subjective data. For example:

• Method Comparison: The "ground truth" is provided by the LC-MS/MS method (a gold standard analytical technique for tacrolimus quantification). The predicate device also serves as a comparison.
• Dilution Recovery and Spike Recovery: The "ground truth" is the known concentration of tacrolimus added to the samples.
• Specificity: The "ground truth" for cross-reactivity is the known chemical structure and concentration of the potential interfering substances.

4. Adjudication Method for the Test Set

This is not applicable to this type of device. Adjudication methods (like 2+1, 3+1) are typically used in studies where multiple human readers independently assess data (e.g., medical images) and a consensus is needed to establish ground truth or resolve discrepancies. For this immunoassay, results
are quantitative measurements, not subjective interpretations.

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

No, an MRMC comparative effectiveness study was not done. This type of study assesses how human readers' performance changes with an AI aid. The QMS® Tacrolimus Immunoassay is an in vitro diagnostic device that quantifies a substance in whole blood through an automated process, not an AI system that assists human interpretation of complex medical cases.

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

Yes, the performance studies detailed in the summary (Functional Sensitivity, Precision, Dilution Recovery, Spike Recovery, Method Comparison, Specificity, Interfering Substances, and Stability) represent the standalone performance of the QMS® Tacrolimus Immunoassay. This device operates as an automated system to quantify tacrolimus, without direct human intervention in the interpretative process during testing. The results are generated by the algorithm/device itself.

7. The Type of Ground Truth Used

The ground truth used for validating the QMS® Tacrolimus Immunoassay stems from:

• Reference Method: For method comparison, the LC-MS/MS (Liquid Chromatography-Mass Spectrometry/Mass Spectrometry) method served as the primary reference standard. This is considered a highly sensitive and specific analytical technique for drug quantification.
• Known Concentrations: For studies like Functional Sensitivity, Dilution Recovery, Spike Recovery, Specificity, and Interfering Substances, the ground truth was based on samples with known, precisely prepared concentrations of tacrolimus, its metabolites, co-administered drugs, or endogenous interfering substances.
• Predicate Device Comparison: The previously cleared Abbott ARCHITECT® Tacrolimus Assay served as a comparative reference method for demonstrating substantial equivalence.

8. The Sample Size for the Training Set

The document does not specify a training set sample size. For an immunoassay, the concept of a "training set" in the context of machine learning (where algorithms learn from data) is not directly applicable in the same way. The immunoassays are developed and optimized through iterative processes using various reagents, controls, and calibration materials, rather than "training" an algorithm on a distinct dataset.

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

As noted above, a traditional "training set" with ground truth in the sense of machine learning is not described or applicable here. The development and optimization of an immunoassay rely on established chemical and biological principles, precise formulation of reagents, and validation against reference methods and known standards to ensure accuracy and reliability. The ground truth for such development is built upon fundamental analytical chemistry and knowledge of the analyte (tacrolimus).

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The Abbott Phenobarbital assay is for in vitro diagnostic use for the quantitative measurement of phenobarbital in human serum or plasma on the ARCHITECT cSystems. The measurements obtained are used in the diagnosis and treatment of phenobarbital overdose and in monitoring levels of phenobarbital to help ensure appropriate therapy.

The Phenobarbital Assay kit is supplied ready-to-use in liquid form, for storage at 2 to 8°C. Each Phenobarbital Assay kit is packaged in a rectangular cardboard box divided into three sections. One section will contain three bottles of Antibody Reagent (R1), one section will contain three bottles of Microparticle Reagent (R2), and the last section will contain the package insert. Each kit is sufficient for 300 tests.

The Abbott Phenobarbital Assay demonstrated substantial equivalence to the predicate device (Abbott Aerosett Phenobarbital Assay (K993031)) through a series of performance studies. The studies assessed various analytical characteristics of the device to ensure it meets its intended use for the quantitative measurement of phenobarbital in human serum or plasma.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Limit of Quantitation (LOQ): The text indicates the LOQ was measured "over an extended period" but does not specify the exact number of samples or runs.
• Precision: Not explicitly stated, but the study followed a CLSI protocol, which typically involves multiple samples tested over several runs and days.
• Spike Recovery: "Negative serum samples were spiked with phenobarbital at concentrations across the assay range." The exact number of samples is not stated.
• Method Comparison: 108 samples (n=108) were tested.
• Matrix Comparison: The following matrices were tested: serum in glass, serum in plastic, serum separator tube (SST) in plastic, plasma with sodium fluoride/potassium oxalate in plastic, plasma with sodium heparin in plastic and glass, plasma with lithium heparin in plastic with or without gel, plasma with K3 EDTA in glass and plastic, plasma with K2 EDTA in plastic, and sodium citrate in plastic and glass. The number of samples for each matrix is not specified.
• Specificity (Cross-Reactivity/Interference): Not explicitly stated, but implies multiple substances were tested across various concentrations.
• Linearity: "Samples were tested to demonstrate linearity throughout the assay range." The exact number of samples is not specified.
• Onboard Stability, Standard Curve Calibration Stability, Reagent Shelf Life Stability: These studies involve testing over time with an unspecified number of samples or replicates.

Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given the nature of in vitro diagnostic device testing for regulatory submission, it is typically prospective, controlled laboratory studies using prepared samples (spiked, diluted, or well-characterized patient samples).

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

This type of submission for an in vitro diagnostic assay does not typically involve expert clinical readers or radiologists. The "ground truth" for the test set is established by:

• Reference Methods: For method comparison, High-Performance Liquid Chromatography (HPLC) results are used as the reference method ("gold standard") for phenobarbital concentration. This approach does not involve human expert interpretation in the same way imaging studies might.
• Known Concentrations: For studies like linearity, spike recovery, LOQ, and precision, samples are prepared with known, precisely measured concentrations of phenobarbital.
• CLSI Protocols: The reference to CLSI protocols indicates established laboratory standards are followed for experimental design and data analysis, ensuring the rigor of the "ground truth" establishment through standardized procedures.

Therefore, there are no "experts" in the clinical interpretation sense involved in establishing the ground truth; rather, the ground truth is analytically derived.

4. Adjudication Method for the Test Set

Not applicable. As described above, the ground truth is established through analytical reference methods or known sample compositions, not through human adjudication of clinical findings.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is an in vitro diagnostic assay for quantitative measurement, not an AI-assisted diagnostic imaging or clinical decision support tool that involves human readers.

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

The entire performance evaluation is inherently a "standalone" or "algorithm-only" assessment in the context of an automated IVD assay. The Abbott Phenobarbital Assay, once calibrated, quantifies phenobarbital concentration based on its reaction kinetics. The performance studies detailed are evaluating this standalone analytical performance.

7. The Type of Ground Truth Used

The ground truth used in these studies is primarily:

• Reference Method Assays: For method comparison, HPLC (High-Performance Liquid Chromatography) served as the reference method for confirming phenobarbital concentrations.
• Known Concentrations: For precision, linearity, LOQ, and spike recovery, samples were prepared with known, established concentrations of phenobarbital.

8. The Sample Size for the Training Set

The document describes performance testing for a finished device. It does not provide information about a "training set" in the context of machine learning, as this is a chemical assay, not an AI/ML device. Therefore, the concept of a training set as understood in AI/ML is not applicable here. The assay is "trained" or optimized during its development phase through iterative experimentation, but the data for this is not detailed in a 510(k) summary (which focuses on verification and validation).

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

Not applicable, as there is no "training set" in the AI/ML sense. The "ground truth" for the development and optimization of the assay would have been established through precisely prepared samples with known phenobarbital concentrations and comparisons to established analytical methods during the research and development phases of the assay.

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Thermo Scientific MAS® Omni•IMMUNE is intended for use as an assayed control for monitoring assay conditions in many clinical laboratory determinations. Include OmnirIMMUNE with patient serum specimens when assaying for any of the listed constituents. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument

Thermo Scientific MAS® Omni•IMMUNE PRO is intended for use as an assayed control for monitoring assay conditions in many clinical laboratory determinations. Include Omni•IMMUNE PRO with patient serum specimens when assaying for any of the listed constituents. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument.

Omni•IMMUNE is a liquid stable control material prepared from human serum. Analyte levels are adjusted with various pure chemicals and preparations from human tissue or body fluids. Preservatives and stabilizers are added to maintain product integrity.

The control is offered in three levels with the following configuration:

MAS® Omni•IMMUNE
Catalog Number Description Size
OIM-101 Level 1 6 vials of Level 1, 5 mLs per vial
OIM-202 Level 2 6 vials of Level 2, 5 mLs per vial
OIM-303 Level 3 6 vials of Level 3, 5 mLs per vial
OIM-SP Sample-pack 1 vial of Level 1, 5 mLs per vial
1 vial of Level 2, 5 mLs per vial
1 vial of Level 3, 5 mLs per vial

MAS® Omni•IMMUNE PRO
Catalog Number Description Size
OPRO-1 Level 1 6 vials of Level 1, 5 mLs per vial
OPRO-2 Level 2 6 vials of Level 2, 5 mLs per vial
OPRO-3 Level 3 6 vials of Level 3, 5 mLs per vial
OPRO-SP Sample-pack 1 vial of Level 1, 5 mLs per vial
1 vial of Level 2, 5 mLs per vial
1 vial of Level 3, 5 mLs per vial

This document is a 510(k) summary for a Quality Control Material (assayed and unassayed), not an AI medical device. Therefore, many of the requested elements for describing an AI device's acceptance criteria and study are not applicable.

However, I can extract the relevant information from the provided text regarding the device's performance and the study demonstrating its equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device (quality control material), the "acceptance criteria" relate to demonstrating substantial equivalence to a predicate device, primarily through comparable design, intended use, and performance characteristics in the context of quality control. The "reported device performance" focuses on the stability and matrix properties of the control material, and its ability to function as intended across various analytes.

The following points are largely not applicable as the device is a quality control material, not an AI device. I will address them with "N/A" and briefly explain why if appropriate.

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

• N/A. This is a quality control material, not an AI algorithm processing diagnostic images or patient data. The "test set" would primarily involve internal laboratory validation of the control material's stability, homogeneity, and assigned values across various assay systems, rather than a dataset of patient samples in the traditional sense of an AI study. The data provenance would be internal laboratory testing data.

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

• N/A. Ground truth for a quality control material involves establishing precise target values and acceptable ranges for analytes. This is done through extensive analytical testing, calibration, and statistical analysis by qualified laboratory scientists and chemists, not "experts" in the clinical diagnostic sense of interpreting patient results.

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

• N/A. Adjudication methods like 2+1 or 3+1 are used in clinical studies where expert consensus is needed to establish a "true" diagnosis or finding for a given patient case, often in the context of medical imaging interpretation. This is not relevant for the technical validation of a laboratory quality control material.

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

• N/A. This device is a quality control material for laboratory assays, not an AI-powered diagnostic tool, and therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed.

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

• N/A. This device is a consumable laboratory reagent, not an algorithm. Its "performance" is inherent in its chemical composition and stability characteristics, which allow it to provide known concentrations of analytes for quality control purposes.

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

• For a quality control material, the "ground truth" (i.e., the assigned values and acceptable ranges for each analyte) are established through:
  • Reference Methods: Using highly accurate and precise reference methods to determine the true concentration of each analyte in the control material.
  • Inter-laboratory Consensus: Often involving assays on multiple high-performing instruments across different laboratories to ensure robustness and generalizability of the assigned values.
  • Traceability: Ensuring traceability to recognized international standards (where available) for the analytes.

8. The sample size for the training set

• N/A. This device is not an AI algorithm and does not have a "training set."

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

• N/A. As there is no training set for an AI algorithm, this question is not applicable.

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The CEDIA® Cocaine OFT Assay is intended for use in the qualitative determination of cocaine in human oral fluid at a cutoff concentration of 15 ng/mL in neat oral fluid. The specimen must be collected exclusively with the Oral-Eze™ Saliva Collection System. The assay is calibrated against benzoylecgonine and performed on the MGC240. This in vitro diagnostic device is intended for clinical laboratory use only.

The CEDIA Cocaine OFT Assay provides only a preliminary analytical test result. A more specific alternative method must be used to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC/MS) and Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drug of abuse test result particularly when preliminary positive results are used.

The CEDIA® Cocaine OFT Assay uses recombinant DNA technology (US Patent No. 4708929) to produce a unique homogeneous enzyme immunoassay system. The assay is based on the bacterial enzyme β-galactosidase, which has been genetically engineered into two inactive fragments i.e., enzyme acceptor (EA) and enzyme donor (ED). These fragments spontaneously reassociate to form fully active enzyme that, in the presence of cocaine or cocaine metabolites, will have reduced activity due to competition for binding sites.

The CEDIA® Cocaine OFT Assay is an in vitro diagnostic device intended for qualitative determination of cocaine in human oral fluid at a cutoff concentration of 15 ng/mL using the Oral-Eze™ Saliva Collection System on the MGC240. The assay provides a preliminary analytical test result, requiring a more specific alternative method like GC/MS or LC-MS/MS for confirmation.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria with numerical targets for sensitivity, specificity, or concordance. Instead, it presents the "Method Comparison" results as the primary performance metrics. The implicit acceptance criterion appears to be "high concordance" with the confirmatory method (GC/MS).

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

The document does not specify the exact sample size used for the method comparison study. It only mentions "All samples tested" for qualitative precision and cutoff characterization, which is not a specific number.

The data provenance is not explicitly stated regarding country of origin. The study appears to be a retrospective comparison, as it's comparing the device's results to a confirmatory method (GC/MS) implying the samples were processed and analyzed. There is no indication of a prospective study design.

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

The document does not specify the number of experts used or their qualifications for establishing the ground truth. The ground truth was established by Gas Chromatography/Mass Spectrometry (GC/MS), which is a laboratory analytical method, not human expert consensus.

4. Adjudication Method for the Test Set

Since the ground truth was established by a laboratory analytical method (GC/MS) rather than human interpretation, an adjudication method for human readers is not applicable and therefore not mentioned.

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

There is no indication that a multi-reader multi-case (MRMC) comparative effectiveness study was done. The study focuses on the standalone performance of the assay compared to a gold standard analytical method.

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

Yes, a standalone study was performed. The "Method Comparison" directly assesses the performance of the CEDIA® Cocaine OFT Assay itself (the "device") against the GC/MS reference method. The assay produces a preliminary analytical test result without direct human interpretation being part of its core performance measurement in this context. While clinical consideration and professional judgment are mentioned for the use of the preliminary positive results, the performance metrics (sensitivity, specificity, concordance) are purely for the device's analytical capability.

7. Type of Ground Truth Used

The type of ground truth used was Gas Chromatography/Mass Spectrometry (GC/MS). This is a highly accurate and preferred confirmatory analytical method for drug testing, essentially serving as an objective "gold standard" for the presence or absence of cocaine.

8. Sample Size for the Training Set

The document does not specify the sample size for any training set. As this is an immunoassay, the "training" analogous to machine learning would typically involve assay development and optimization using characterized samples, but this is not detailed.

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

The document provides no information on how the ground truth for any training set was established. The focus of the provided text is on the performance evaluation of the final commercialized assay.

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The CEDIA® Phencyclidine (PCP) OFT Assay is intended for use in the qualitative determination of phencyclidine in human oral fluid at a cutoff concentration of 3 ng/mL in neat oral fluid. The specimen must be collected exclusively with the Oral-Eze™ Saliva Collection System. The assay is calibrated against PCP and performed on the MGC 240. This in vitro diagnostic device is intended for clinical laboratory use only.

The CEDIA Phencyclidine (PCP) OFT Assay provides only a preliminary analytical test result. A more specific alternative method must be used to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC/MS) and Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drug of abuse test result particularly when preliminary positive results are used.

Microgenics CEDIA® PCP OFT Assay uses recombinant DNA technology to produce a unique homogeneous enzyme immunoassay system. The assay is based on the bacterial enzyme β-galactosidase, which has been genetically engineered into two inactive fragments. These fragments spontaneously re-associate to form fully active enzyme that, in the assay format, cleave a substrate, generating a color change that can be measured spectrophotometrically.

Here's an analysis of the provided text regarding the acceptance criteria and study for the CEDIA® Phencyclidine (PCP) OFT Assay:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state quantitative acceptance criteria (e.g., "sensitivity must be >95%"). Instead, it describes performance in qualitative terms. However, based on the stated "Method Comparison" results, we can infer the implicit acceptance criteria that the device should demonstrate high concordance, sensitivity, and specificity with a confirmed method.

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

The document does not explicitly state the sample size used for the test set in the "Method Comparison" study that determined 100% concordance, sensitivity, and specificity. It also does not specify the country of origin for the data or whether it was retrospective or prospective.

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

The document does not mention the use of human experts to establish ground truth for the test set. Instead, the ground truth was established by confirmatory analytical methods (GC/MS).

4. Adjudication Method for the Test Set:

Not applicable. The ground truth was established through analytical methods (GC/MS), not through expert review requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:

Not applicable. This device is an in vitro diagnostic assay, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study and analysis of human reader improvement with AI assistance are not relevant.

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

Yes, the studies presented are standalone performance evaluations of the assay itself. The "Method Comparison" directly compares the device's output to the gold standard (GC/MS) without human interpretation as an intermediate step.

7. The Type of Ground Truth Used:

The ground truth used for the "Method Comparison" study was Gas Chromatography/Mass Spectrometry (GC/MS). The document also mentions Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) as an alternative preferred confirmatory method.

8. The Sample Size for the Training Set:

The document does not explicitly state the sample size used for any training set. This is typical for an immunoassay, as it's not a machine learning model that undergoes explicit "training" on a dataset in the same way. The assay's performance is established through analytical validation studies on samples.

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

Not applicable in the context of "training set" for a machine learning model. For the assay's development and validation, the ground truth for samples used in analytical studies (e.g., precision, cutoff characterization, interference, specificity) would have been established through controlled spiking of known concentrations or independent confirmatory methods such as GC/MS for validation of spiked samples. The document implies that the assay was calibrated against PCP.

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The CEDIA® Multi-Drug OFT Calibrators are intended for use in the calibration of d-Amphetamine, Benzoylecgonine, Morphine and Phencyclidine (PCP) in human Oral Fluid when used with the CEDIA Amphetamine, Cocaine, Opiate, and Phencyclidine (PCP) OFT Assays on the MGC 240 analyzer. This in vitro diagnostic device is intended for clinical laboratory use only.

The CEDIA® Multi-Drug OFT Calibrators are liquid ready-to-use. They are prepared by spiking known quantities of Amphetamine, Benzoylecgonine, Morphine and PCP in to buffer matrix. The Cutoff Calibrator is used as a qualitative cutoff reference for distinguishing "positive" from "negative" samples. The concentration for each drug in the calibrators is listed in table below. Concentrations for each calibrator are confirmed by LC-MS/MS methodology.

The provided text describes a 510(k) submission for the CEDIA® Multi-Drug OFT Calibrators, focusing on its substantial equivalence to a predicate device. It does not contain information about specific acceptance criteria or a study proving the device meets those criteria in the context of device performance metrics like sensitivity, specificity, or accuracy.

The document primarily focuses on:

• Intended Use: Calibration of specific drugs (d-Amphetamine, Benzoylecgonine, Morphine, Phencyclidine (PCP)) in human Oral Fluid when used with CEDIA OFT Assays on the MGC 240 analyzer.
• Device Description: Liquid, ready-to-use calibrators prepared by spiking known quantities of drugs into a buffer matrix. Concentrations are confirmed by LC-MS/MS.
• Comparison to Predicate Device: Table outlining similarities and differences in intended use, analytes, matrix, form, calibrator levels, and storage temperature.
• Conclusion: Substantial equivalence due to performance testing verifying intended function and satisfaction of design specifications.

Therefore, based on the provided text, I cannot provide answers to the requested information (1-9) as they pertain to performance acceptance criteria and efficacy studies typically found in clinical validation reports for diagnostic devices.

The document states: "Substantial equivalence has been demonstrated through performance testing to verify that the device functions as intended and that design specifications have been satisfied." However, it does not provide any details about this "performance testing," including:

• Specific acceptance criteria: What quantitative thresholds were set for performance?
• Performance results: What were the reported metrics (e.g., accuracy, precision, bias)?
• Study design details: Sample size, data provenance, ground truth establishment, expert involvement, etc.

Without this information, it's impossible to fill in the requested table or answer the subsequent questions about the study. This document appears to be just the 510(k) summary and the FDA's clearance letter, not the detailed performance study report itself.

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The CEDIA® Methamphetamine OFT Assay is intended for use in the qualitative detection of methamphetamine at a cutoff concentration of 120.0 ng/mL in neat oral fluid. The specimen must be collected exclusively with the Oral-Eze™ Saliva Collection System. The assay is calibrated against d-methamphetamine and performed on the MGC 240. This in vitro diagnostic device is intended for clinical laboratory use only.

The CEDIA Methamphetamine OFT Calibrators are intended for use in the calibration of d-Methamphetamine when used with the CEDIA Methamphetamine OFT Assay for human oral fluid samples collected with the Oral-Eze™ Saliva Collection System. This in vitro diagnostic device is intended for clinical laboratory use only.

The CEDIA Methamphetamine OFT Assay provides only a preliminary analytical test result. A more specific alternative method must be used to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC/MS) and Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drug of abuse test result particularly when preliminary positive results are used.

The CEDIA® Methamphetamine OFT Assay uses recombinant DNA technology to produce a unique homogeneous enzyme immunoassay system. The assay is based on the bacterial enzyme ß-galactosidase, which has been genetically engineered into two inactive fragments i.e., enzyme acceptor (EA) and enzyme donor (ED). These fragments spontaneously reassociate to form fully active enzyme that, in the assay format, cleaves a substrate, generating a color change that can be measured spectrophotometrically.

In the assay, analyte in the sample competes with analyte conjugated to one inactive fragment of ß-galactosidase for antibody binding site. If analyte is present in the sample, it binds to antibody, leaving the inactive enzyme fragments free to form active enzyme. If analyte is not present in the sample, antibody binds to analyte conjugated on the inactive fragment, inhibiting the reassociation of inactive ß-galactosidase fragments, and no active enzyme is formed. The amount of active enzyme formed and resultant absorbance change are directly proportional to the amount of drug present in the sample.

The Oral-Eze™ Saliva Collection System consists of Oral-Eze™ saliva collector and collection tube with preservative buffer. Oral-Eze™ saliva collector consists of an absorbent pad attached to a plastic handle. The saliva collector is provided with a volume adequacy indicator. The plastic handle has a round window where blue color will appear when sufficient volume of oral fluid is collected. Samples are collected by placing the collector pad and plastic shield between lower cheek and gum with the plastic shield facing the cheek. Oral fluid collection is done when blue color appears in the window of the handle. The pad is ejected in to the collection tube by placing thumb on the ridges on the handle and pushing the thumb forward. The collection tube is capped and sent to the laboratory for processing and testing.

Here's an analysis of the acceptance criteria and study details for the CEDIA® Methamphetamine OFT Assay, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary doesn't explicitly state "acceptance criteria" in a quantitative format as might be found for imaging devices. Instead, it presents performance characteristics that implicitly serve as the basis for demonstrating substantial equivalence. The key performance metrics are related to accuracy (concordance, sensitivity, specificity) against a reference method (GC/MS).

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

• Sample Size for Test Set: The document does not explicitly state the total number of individual patient samples used in the "Method Comparison" study that determined concordance, sensitivity, and specificity. It only states "The overall concordance between the CEDIA® Methamphetamine OFT Assay and GC/MS is 98.8%." Without the raw numbers of true positives, true negatives, false positives, and false negatives, the exact sample size cannot be determined from this summary.
• Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. It implies the data was collected for the purpose of this submission (likely prospective data collection in a laboratory setting).

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

• This device is an in vitro diagnostic (IVD) assay, not an imaging AI device that relies on human interpretation for ground truth.
• The ground truth in this context is established by the Gas Chromatography/Mass Spectrometry (GC/MS) method. This is an objective, analytical gold standard for substance identification and quantification. Therefore, human experts are not directly involved in establishing the "ground truth" for individual test samples, though expert technicians operate and validate the GC/MS instruments.

4. Adjudication Method for the Test Set

• Not applicable. As noted above, the ground truth is established by an objective analytical method (GC/MS), not by human interpretation requiring adjudication.

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

• No, a "Multi-Reader Multi-Case (MRMC)" comparative effectiveness study was not done. This type of study design is typically used for medical imaging devices where human readers interpret images, and the AI's effect on their performance is being evaluated. This device is an automated IVD assay, not an AI for image interpretation.

6. Standalone Performance

• Yes, a standalone performance study was done. The "Method Comparison" section directly evaluates the CEDIA® Methamphetamine OFT Assay's performance (concordance, sensitivity, specificity) against the GC/MS reference method. This is a measure of the algorithm's (assay's) performance without human-in-the-loop interaction for interpretation, beyond standard laboratory procedures for running the assay.

7. Type of Ground Truth Used

• The ground truth used is objective analytical data from Gas Chromatography/Mass Spectrometry (GC/MS). The summary also mentions Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) as another preferred confirmatory method. These methods are considered the gold standard for drug detection and quantification.

8. Sample Size for the Training Set

• The document does not explicitly state a "training set" size. For an IVD assay like this, the development process involves extensive analytical validation, including testing numerous samples to establish linearity, precision, interference, cross-reactivity, and cutoff optimization. However, it's not typically described in terms of a "training set" like a machine learning model. The various studies (Qualitative Precision, Qualitative Cutoff Characterization, Interference, Specificity and Cross-Reactivity, Method Comparison) collectively represent the data used to characterize and validate the assay's performance.

9. How Ground Truth for the Training Set Was Established

• For the development and optimization of such an assay, ground truth would be established through:

  • Known concentrations: Samples spiked with precise, known concentrations of methamphetamine and its metabolites.
  • GC/MS or LC-MS/MS confirmation: Samples from real-world scenarios would be confirmed by gold-standard analytical methods (GC/MS or LC-MS/MS) to establish their true status (positive/negative and concentration).
  • Reference materials: Use of certified reference materials and calibrators with established values.

  The summary does not detail the specific methodology for establishing ground truth during the assay's development (what would functionally be analogous to a "training set" in AI development), but it implies standard IVD development practices involving these types of validated samples.

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The CEDIA® Cannabinoids OFT Assay is intended for use in the qualitative determination of Cannabinoids in human oral fluid at a cutoff concentration of 3 ng/mL in neat oral fluid. The specimen must be collected exclusively with the Oral-Eze™ Saliva Collection System. The assay is calibrated against 1-Δ THC and performed on the MGC 240. This in vitro diagnostic device is intended for clinical laboratory use only.

The CEDIA THC OFT Calibrators are intended for use in the calibration of I-Δ THC when used with the CEDIA Cannabinoids OFT Assay. This in vitro diagnostic device is intended for clinical laboratory use only.

The CEDIA Cannabinoids OFT Assay provides only a preliminary analytical test result. A more specific alternative method must be used to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC/MS) and Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drug of abuse test result particularly when preliminary positive results are used.

Microgenics CEDIA® Cannabinoids OFT Assay uses recombinant DNA technology to produce a unique homogeneous enzyme immunoassay system. The assay is based on the bacterial enzyme ß-aalactosidase, which has been genetically engineered into two inactive fragments. These fragments spontaneously re-associate to form fully active enzyme that, in the assay format, cleave a substrate, generating a color change that can be measured spectrophotometrically.

In the assay, analyte in the sample competes with analyte conjugated to one inactive fragment (enzyme donor) of 0-galactosidase for antibody binding site. If analyte is present in the sample, it binds to antibody, leaving the inactive enzyme fragment free to form active enzyme. If the analyte is not present in the sample, antibody binds to analyte conjugated on the inactive fragment, inhibiting the re-association of inactive B-qalactosidase fragments. and no active enzyme is formed. The amount of active enzyme formed and resultant absorbance change are directly proportional to the amount of analyte present in the sample.

The Oral-Eze™ Saliva Collection System consists of Oral-Eze™ saliva collector and collection tube with preservative buffer. Oral-Eze™ saliva collector consists of an absorbent pad attached to a plastic handle. The saliva collector is provided with a volume adequacy indicator. The plastic handle has a round window where blue color will appear when sufficient volume of oral fluid is collected. Samples are collected by placing the collector pad and plastic shield between lower cheek and gum with the plastic shield facing the cheek. Oral fluid collection is done when blue color appears in the window of the handle. The pad is ejected in to the collection tube by placing thumb on the ridges on the handle and pushing the thumb forward. The collection tube is capped and sent to the laboratory for processing and testing.

Acceptance Criteria and Device Performance for CEDIA® Cannabinoids OFT Assay

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for Test Set

The document does not explicitly state the sample size used for the qualitative method comparison test set (comparison with GC/MS). It only reports percentages for concordance, sensitivity, and specificity.

The data provenance is not explicitly mentioned, but given the context of a 510(k) submission to the FDA, it is highly likely that the studies were conducted in a retrospective manner using collected human oral fluid samples. The country of origin of the data is not specified.

3. Number of Experts and Qualifications for Ground Truth (Test Set)

The document does not specify the number of experts or their qualifications used to establish the ground truth for the test set.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the test set. The ground truth appears to be established by Gas Chromatography/Mass Spectrometry (GC/MS), which is typically considered a definitive method, minimizing the need for expert adjudication in interpreting the GC/MS results themselves.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is an in vitro diagnostic assay, not an AI-powered image analysis tool or decision support system that would involve human readers. Therefore, the concept of human readers improving with or without AI assistance is not applicable here.

6. Standalone Performance Study

Yes, a standalone performance study was done. The entire summary of clinical testing (Qualitative Precision, Qualitative Cutoff Characterization, Interference, Specificity and Cross-Reactivity, and Qualitative Method Comparison) evaluates the performance of the CEDIA® Cannabinoids OFT Assay as a standalone algorithm (without human-in-the-loop performance). The comparison with GC/MS directly assesses its analytical accuracy.

7. Type of Ground Truth Used (Test Set)

The type of ground truth used for the significant performance metrics (concordance, sensitivity, and specificity) was Gas Chromatography/Mass Spectrometry (GC/MS). The document also mentions Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) as an alternative preferred confirmatory method, implying GC/MS is the primary reference.

8. Sample Size for Training Set

The document does not provide any information about a training set or its sample size. This is typical for traditional in vitro diagnostic assays which are often developed and validated using analytical studies rather than machine learning models that require distinct training and test sets.

9. How Ground Truth for Training Set Was Established

Since no training set is mentioned, information on how its ground truth was established is not provided.

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The CEDIA® Opiate OFT Assay is intended for use in the qualitative determination of opiate in human oral fluid at a cutoff concentration of 30 ng/mL in neat oral fluid. The specimen must be collected exclusively with the Oral-Eze™ Saliva Collection System. The assay is calibrated against morphine and performed on the MGC240. This in vitro diagnostic device is intended for clinical laboratory use only.

The CEDIA Opiate OFT Assay provides only a preliminary analytical test result. A more specific alternative method must be used to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC/MS) and Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drug of abuse test result particularly when preliminary positive results are used.

Microgenics CEDIA® Opiate OFT Assay uses recombinant DNA technology to produce a unique homogeneous enzyme immunoassay system. The assay is based on the bacterial enzyme ß-galactosidase, which has been genetically engineered into two inactive fragments. These fragments spontaneously re-associate to form fully active enzyme that, in the assay format, cleave a substrate, generating a color change that can be measured spectrophotometrically.

In the assay, analyte in the sample competes with analyte conjugated to one inactive fragment (enzyme donor) of β-galactosidase for antibody binding site. If analyte is present in the sample, it binds to antibody, leaving the inactive enzyme fragment free to form active enzyme. If the analyte is not present in the sample, antibody binds to analyte conjugated on the inactive fragment, inhibiting the re-association of inactive β-galactosidase fragments, and no active enzyme is formed. The amount of active enzyme formed and resultant absorbance change are directly proportional to the amount of analyte present in the sample.

The Oral-Eze™ Saliva Collection System consists of Oral-Eze™ saliva collector and collection tube with preservative buffer. Oral-Eze™ saliva collector consists of an absorbent pad attached to a plastic handle. The saliva collector is provided with a volume adequacy indicator. The plastic handle has a round window where blue color will appear when sufficient volume of oral fluid is collected. Samples are collected by placing the collector pad and plastic shield between lower cheek and gum with the plastic shield facing the cheek. Oral fluid collection is done when blue color appears in the window of the handle. The pad is ejected in to the collection tube by placing thumb on the ridges on the handle and pushing the thumb forward. The collection tube is capped and sent to the laboratory for processing and testing.

This document describes the acceptance criteria and the study performance for the CEDIA® Opiate OFT Assay, a device intended for the qualitative determination of opiates in human oral fluid.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document implies acceptance criteria based on the reported "accurate" recovery and "no significant" interference/cross-reactivity, along with high concordance/sensitivity/specificity values.

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

The document does not explicitly state the exact sample size for the "test set" used in the method comparison study. It only mentions "The overall concordance between the CEDIA® Opiate OFT Assay and GC/MS is 97.6%."

Data Provenance: The document does not specify the country of origin of the data. It is a retrospective study comparing the new assay's results against a confirmatory method (GC/MS).

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

This device is an in vitro diagnostic (IVD) assay, not an imaging or interpretation device that typically relies on human experts for ground truth establishment in the same way clinical diagnostic studies might.

For IVD assays like this, the "ground truth" for the test set is established by a confirmatory analytical method, in this case, Gas Chromatography/Mass Spectrometry (GC/MS). Therefore, the concept of "number of experts" and their "qualifications" for establishing ground truth as it would apply to interpretive tasks (e.g., radiologists reading images) is not directly applicable here. The experts involved would be the laboratory personnel performing and interpreting the GC/MS results, who are qualified to operate and interpret results from such sophisticated analytical equipment.

4. Adjudication Method for the Test Set

Not applicable. As described above, the ground truth is established by a confirmatory analytical method (GC/MS), not by human expert consensus or adjudication in the traditional sense. Discordant results between the CEDIA® Opiate OFT Assay and GC/MS would be resolved by the GC/MS result, which is considered the "gold standard" for confirmation.

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

No, an MRMC comparative effectiveness study was not done. This is an in vitro diagnostic assay, and its performance is evaluated based on its analytical characteristics and concordance with a reference method, not human reader performance.

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

Yes, a standalone performance evaluation was done. The study assesses the performance of the CEDIA® Opiate OFT Assay itself, comparing its results directly to the GC/MS confirmatory method without human interpretation as an intermediate step. The assay provides a "preliminary analytical test result" which then requires confirmation by GC/MS or LC-MS/MS.

7. The Type of Ground Truth Used

The type of ground truth used is confirmatory analytical testing, specifically Gas Chromatography/Mass Spectrometry (GC/MS). The document states: "A more specific alternative method must be used to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC/MS) and Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) are the preferred confirmatory methods."

8. The Sample Size for the Training Set

The document does not provide information about a "training set" or "training data" in the conventional sense used for machine learning algorithms. This is an immunoassay, and its development involves analytical validation, not a distinct training phase with a labeled dataset in the way AI/ML devices do. The performance characteristics are established through various analytical studies (precision, cutoff characterization, interference, specificity, method comparison).

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

Not applicable. As mentioned above, this is an immunoassay and does not have a "training set" in the context of machine learning. The assay mechanism is based on biochemical reactions and genetic engineering (recombinant DNA technology), not on learning from a dataset.

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