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The Chromsystems MassCheck Immunosuppressant Whole Blood Controls are in vitro diagnostic devices intended to verify performance of various laboratory assay systems that measure cyclosporine, tacrolimus, or sirolimus.

The Chromsystems MassCheck Immunosuppressant Controls are Ivophilized, multi-analyte human whole blood based products containing the analytes Ciclosporin A, Rapamycin (Sirolimus) and Tacrolimus. The Controls are available as four levels + blank. Prior to use the different lyophilized controls need to be reconstituted by adding the corresponding amount of water as indicated on the respective packing leaflet. Each donor was tested and found negative for Human immunodeficiency virus (HIV) 1 and 2, Hepatitis B virus (HBV), Hepatitis C virus (HCV) in European blood banks. The tests used were cleared for in vitro diagnostic use in the EU (in compliance with the European Directive 98/79/EC on in vitro Diagnostic Medical Devices as Annex II, List A products) and are also approved by the Paul-Ehrlich-Institute in Germany.

The document provided is a 510(k) summary for the Chromsystems MassCheck Immunosuppressants Whole Blood Controls. This type of device is a control material used to verify the performance of laboratory assay systems that measure concentrations of immunosuppressant drugs.

Based on the information provided in the document, here's a breakdown regarding acceptance criteria, study details, and related aspects:

1. Table of Acceptance Criteria and Reported Device Performance:

The 510(k) summary does not explicitly state specific acceptance criteria in terms of numerical thresholds (e.g., ±X% accuracy, Y% precision).
It also does not report specific performance data for the Chromsystems MassCheck Immunosuppressants Whole Blood Controls.

Instead, the submission primarily focuses on demonstrating substantial equivalence to predicate devices. The claim of substantial equivalence is based on the following similarities:

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

The document does not describe a specific "test set" in the context of a performance study with a defined sample size for the proposed device itself, nor does it specify data provenance (country of origin, retrospective/prospective).

The submission relies on a comparison to predicate devices, implying that the performance of the proposed device is expected to be similar to that of the already legally marketed predicates. The comparison focuses on the characteristics and intended use rather than new clinical performance data from a specific test set.

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

This information is not applicable or provided in the 510(k) summary. Given that the device is a control material and the submission aims for substantial equivalence based on product characteristics rather than a diagnostic performance claim, there is no mention of an expert panel establishing ground truth for a test set.

4. Adjudication Method for the Test Set:

This information is not applicable or provided for the same reasons as above. No adjudication method is described.

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 or described. This type of study is typically performed for diagnostic imaging or screening devices to assess human reader performance with and without AI assistance. The MassCheck Immunosuppressants Whole Blood Controls are laboratory control materials, not diagnostic AI systems for human interpretation.

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

No, a standalone (algorithm only) performance study was not described. The device is a physical control material, not an algorithm. Its "performance" is in its stability, accuracy of stated concentrations, and ability to challenge an assay system appropriately. These characteristics are typically validated through analytical studies, not an algorithm-only performance study.

7. The Type of Ground Truth Used:

For the purpose of this 510(k) (seeking substantial equivalence for a control material):

• The "ground truth" for the analytes (Ciclosporin A, Rapamycin (Sirolimus), and Tacrolimus) in the control material would be their known, precisely manufactured concentrations.
• The "ground truth" for the safety of the human whole blood matrix is based on testing for specific pathogens (HIV 1 and 2, HBV, HCV) using cleared in vitro diagnostic tests in EU blood banks.

However, the document does not elaborate on how the precise concentrations of the analytes within the controls were verified or how the controls were analytically characterized. The focus is on the device's intended use as a control, not on its own diagnostic accuracy against a gold standard in patient samples.

8. The Sample Size for the Training Set:

This information is not applicable or provided. The device is a manufactured control product, not an AI algorithm that requires a training set.

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

This information is not applicable or provided for the same reason as above.

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The Quantimetrix Corp. NiCosure Cotinine Urine Control is intended as a means of monitoring the performance of GC/MS and other drugs of Cotinine methods used for detecting the Cotinine levels in unknown urine specimens. Use of quality control materials is an integral part of diagnostic procedures. Daily monitoring of control values establishes intralaboratory parameters for accuracy and precision of the test method.

Not Found

This document is a 510(k) clearance letter from the FDA for a medical device called "Quantimetrix NiCosure Cotinine Urine Control." It does not contain information about acceptance criteria or a study proving device performance as requested in the prompt. This letter signifies that the FDA has determined the device is substantially equivalent to legally marketed predicate devices, which is a regulatory decision and not a performance study report.

Therefore, I cannot provide the requested information from the given text.

To answer your specific questions, I would need a document that describes the performance characteristics and validation study of the "Quantimetrix NiCosure Cotinine Urine Control," not just its regulatory clearance.

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The MAS Immunosuppressant Controls, consisting of levels 1 through 3, are in-vitro diagnostic medical devices intended for use as assayed quality control material to monitor the precision of laboratory testing procedures for cyclosporine, sirolimus, and tacrolimus.

MAS Immunosuppressant Controls is prepared from human whole blood, with pure chemicals and stabilizers. The control is provided in a liquid form containing Cyclosporine, Sirolimus, and Tacrolimus.

The provided document is a 510(k) premarket notification for a medical device called "MAS Immunosuppressant Controls." This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with detailed performance metrics and acceptance criteria in the way one might expect for a novel diagnostic algorithm or clinical treatment device.

Therefore, many of the requested categories for defining acceptance criteria and study details cannot be directly extracted from this document, as they are not typically part of a 510(k) for a quality control material. Specifically, this submission does not contain information on device performance in terms of sensitivity, specificity, accuracy, or a clinical study with human readers or pathology ground truth.

However, I can extract the information that is present and indicate where the requested information is not applicable or not provided in this specific type of submission.

Acceptance Criteria and Device Performance

This 510(k) submission for MAS Immunosuppressant Controls does not present specific quantitative acceptance criteria or detailed performance data in the typical sense of a diagnostic device (e.g., sensitivity, specificity, accuracy). Instead, substantial equivalence is claimed based on comparable intended use, physical properties, and a demonstration that the device is safe and effective for its stated purpose as a quality control material.

The implied acceptance criteria are that the control material performs similarly to the predicate device in its intended function: monitoring the precision of laboratory testing procedures for specific immunosuppressants. The study supporting this is a comparison to a predicate device, not an independent performance study against a clinical gold standard.

Study Details

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

   • Sample Size: Not explicitly stated in terms of patient samples or a traditional test set. The comparison is between the control materials themselves. The submission does not detail any "test set" of patient data.
   • Data Provenance: Not applicable. The study is a comparison of product characteristics and intended use, not based on clinical data or patient samples from a specific country or collected retrospectively/prospectively.

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

   • Not Applicable: There is no "ground truth" expert review in the context of this 510(k) submission for a quality control material. The ground truth for individual analyte concentrations in control materials is established through a precise manufacturing and assaying process, not expert consensus on patient data.

3. Adjudication Method for the Test Set:

   • Not Applicable: No adjudication method is mentioned as there is no test set in the conventional sense requiring expert review or adjudication.

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

   • Not Applicable: This is a 510(k) for a quality control material, not an AI-assisted diagnostic device. Therefore, no MRMC study, human readers, or AI assistance is involved.

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

   • Not Applicable: This is not an algorithmic device.

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

   • Not Applicable in the traditional sense: For quality control materials, the "ground truth" for the declared values of the controls is established through the precise manufacturing process and subsequent validated analytical testing of the controls themselves, often against reference methods or certified reference materials, to assign the assayed values. It is not derived from clinical outcomes, pathology, or expert consensus on patient data.

7. The sample size for the training set:

   • Not Applicable: This device does not involve a training set for an algorithm.

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

   • Not Applicable: No training set is involved.

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The DRI® Oxycodone Assay is intended for the qualitative and semi-quantitative detection of oxycodone in human urine. The assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas chromatography /mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical and professional judgment should be applied to any drug of abuse test result, particularly when preliminary results are used.

The DRI® Oxycodone Assay is intended to be used for the qualitative and semiquantitative determination of the presence of oxycodone in human urine at cutoffs of 100 and 300 ng/mL. The assay provides a simple and rapid analytical screening procedure to detect oxycodone in human urine.

The DRI® Oxycodone Calibrators are used to calibrate the DRI® Oxycodone Assay in human urine.

The DRI® Oxycodone Controls are used to qualify the DRI® Oxycodone Assay in human urine.

The DRI® Oxycodone Assay is supplied as liquid ready-to-use homogeneous enzyme immunoassay. The assay uses specific antibodies that can detect oxycodone and oxymonthone without significant cross-reactivity to other opiate compounds. The assay is based on computition between oxycodone labeled with glucose-6-phosphate dehydrogenase (G6PDH), and oxycodone present in the urine sample for a fixed amount of specific antibody binding and a necess. In the absence of free oxycodone in the sample, the specific antibody binds the drug labeled with G6PDH and causes a decrease in enzyme activity. This phenomenon creates a direct relationship between the drug concentration in urine and enzyme activity. The enzyme activity is deternined spectrophotometrically at 340 nm by measuring the conversion of nicotinamide adenine dinucleotide (NAD) to NADH.

The provided text describes the DRI® Oxycodone Assay, its intended use, and its comparison to a predicate device for substantial equivalence. However, it does not contain a formal study, acceptance criteria, or performance data in the structured format requested. The document is primarily a 510(k) summary, which outlines the device's characteristics and its proposed equivalence to a legally marketed predicate device, rather than a detailed report of internal validation studies with explicit acceptance criteria.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for test sets and training sets, data provenance, or details on ground truth establishment for these sets.
3. Information on experts, adjudication methods, or MRMC studies.

Here's what can be extracted based on the provided text, outlining why the requested information is absent:

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

• Acceptance Criteria: Not explicitly stated in the provided text. The document focuses on demonstrating "substantial equivalence" to a predicate device rather than defining specific performance thresholds for the new device and then proving it meets them.
• Reported Device Performance: Performance metrics such as sensitivity, specificity, accuracy, or other diagnostic performance indicators are not provided in this 510(k) summary. The comparison focuses on device characteristics (intended use, analyte, matrix, calibrator form/levels, storage, stability) to show similarity with the predicate.

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

• Sample Size for Test Set: Not specified.
• Data Provenance: Not specified.
• Retrospective or Prospective: Not specified.

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)

• Number of Experts: Not applicable as no specific test set or expert-established ground truth is described.
• Qualifications of Experts: Not applicable.

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

• Adjudication Method: Not applicable as no specific test set or ground truth adjudication process is described.

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

• MRMC Study: Not mentioned. This device is an immunoassay for drug detection, not an imaging device typically evaluated with MRMC studies or human reader performance.
• Effect Size: Not applicable.

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

• Standalone Performance: The device is described as a "homogeneous enzyme immunoassay" and its performance is evaluated in comparison to a predicate device and confirmed by Gas Chromatography/Mass Spectrometry (GC/MS). The document implies a "standalone" analytical performance being assessed, but specific metrics like accuracy against GC/MS are not quantified in this summary.

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

• Ground Truth: For establishing substantial equivalence and confirming performance, the document states, "...as confirmed by gas chromatography/mass spectrometry, an independent analytical method." Therefore, Gas Chromatography / Mass Spectrometry (GC/MS) is explicitly identified as the preferred confirmatory method and the basis for comparison.

8. The sample size for the training set

• Sample Size for Training Set: Not specified. This document relates to a 510(k) submission, not a study design detail for model training.

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

• Ground Truth for Training Set: As no training set is described, the method for establishing its ground truth is not provided.

In summary: The provided text is a 510(k) summary for a diagnostic device. Its purpose is to demonstrate substantial equivalence to a predicate device, as confirmed by an independent analytical method (GC/MS). It does not contain a detailed report of a study with explicit acceptance criteria, performance metrics, or specifics about test and training datasets typically found in a clinical or algorithm validation study report.

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The Microgenics Cyclosporine Controls, consisting of levels 1 through 5, are in-vitro diagnostic medical devices intended for use as assayed quality control material to monitor the precision of laboratory testing procedures for cyclosporine.

The Microgenics Cyclosporine Controls are prepared from whole human blood, with pure chemicals stabilizers added. The control kit includes five separate controls known as C1, C2, C3, C4 and C5 with target concentrations of approximately 70, 200, 350, 700 and 1600 ng cyclosporine/mL. The Microgenics Cyclosporine Controls are provided in lyophilized form for increased stability.

The provided text is a 510(k) summary for the Microgenics Cyclosporine Controls, focusing on demonstrating substantial equivalence to predicate devices rather than detailed performance studies with acceptance criteria in the manner typical for AI/ML device evaluations.

Therefore, many of the requested sections below cannot be fulfilled directly from the provided document as it does not contain information on: a test set for performance evaluation against ground truth, expert involvement for ground truth establishment, adjudication methods, MRMC studies, standalone performance studies, training set details, or explicit acceptance criteria in a quantitative sense for device performance.

Instead, the document focuses on comparing the new device's characteristics and intended use to legally marketed predicate devices to establish substantial equivalence.

Here's an attempt to extract and infer information based on the provided text, while acknowledging the limitations:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria for device performance (e.g., specific accuracy, precision, or bias targets) that would typically be evaluated in a study for a novel diagnostic device. Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to existing predicate devices based on shared characteristics and intended use.

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

Not applicable. The document describes a comparison to predicate devices, not a study involving a "test set" of patient data for evaluating a diagnostic algorithm's performance. The "data" provided is a comparison of product characteristics.

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

Not applicable. This type of information is pertinent to AI/ML or image-based diagnostic devices where ground truth often requires expert labeling or interpretation. This document describes a quality control material.

4. Adjudication Method for the Test Set

Not applicable. There is no test set or adjudication process described.

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

Not applicable. This is not an AI/ML device and therefore, MRMC studies are not relevant to this submission.

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

Not applicable. This is not an algorithmic device.

7. The Type of Ground Truth Used

The "ground truth" in this context is the established characteristics and performance of the predicate devices themselves, deemed safe and effective. The new device demonstrates substantial equivalence by matching these characteristics.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device; there is no training set mentioned or implied.

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

Not applicable. There is no training set.

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The CEDIA® Cyclosporine Plus High Range Controls 4 and 5 are in-vitro diagnostic medical devices intended for use as an assayed quality control material to monitor the precision of laboratory testing procedures for cyclosporine.

Not Found

This looks like an FDA clearance letter for an in-vitro diagnostic device, specifically quality control materials. It does not contain the kind of detailed study information you're asking for regarding acceptance criteria, device performance, sample sizes, expert ground truth, or AI-related metrics.

The document primarily states that the device, CEDIA® Cyclosporine Plus High Range Controls 4 and 5, has been found substantially equivalent to legally marketed predicate devices. It confirms the device's classification and its intended use as an assayed quality control material to monitor the precision of laboratory testing procedures for cyclosporine.

Therefore, I cannot extract the information you've requested from this document. The typical FDA 510(k) summary (or the full submission if it were available) would contain the details of the studies performed to demonstrate substantial equivalence, including performance data.

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Reference Material for Delta-9-THC-COOH in Human Urine is a material intended for use in verifying the accuracy of GC/MS methods used for quantitation of this analyte in human urine.

Reference Material for Delta-9-THC-COOH in Human Urine

The provided text is a 510(k) clearance letter from the FDA for a Reference Material for Delta-9-THC-COOH in Human Urine. This type of device is a calibration or control material used to verify the accuracy of laboratory tests (specifically GC/MS methods) for detecting a marijuana metabolite.

The information you are asking for, such as acceptance criteria, study details, sample sizes, expert qualifications, and ground truth establishment, is not typically found in a 510(k) clearance letter.

A 510(k) clearance letter primarily states that the FDA has reviewed the device and determined it to be "substantially equivalent" to a legally marketed predicate device. This equivalence is based on the data and information provided by the manufacturer in their 510(k) submission, which would contain the study details. However, the clearance letter itself only summarizes the FDA's decision, not the full details of the supporting studies.

Therefore, I cannot provide the requested information from the given document.

To answer your questions, I would need access to the actual 510(k) submission which would include the performance data and study reports.

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The INNOFLUOR™ Topinamate Assay System is a fluorescence polarization immunoassay intended for the quantitative determination of total topiramate in serum or heparinized plaama for therapeutic drug monitoring. The assay system is for use on the Abbott TDxf or the TDxFLX® analyzer.

The INNOFLUOR™ Topiramate Assay System is a fluorescence polarization immunoassay intended for the quantitative determination of total topiramate in serum or heparinized plaama for therapeutic drug monitoring. The assay system is for use on the Abbott TDxf or the TDxFLX® analyzer.

Here's an analysis of the provided text regarding the INNOFLUOR™ Topiramate Control Set, focusing on the requested information.

It's important to note that this 510(k) summary is for a control set within an assay system, not a diagnostic AI device. Therefore, many of the requested categories (like "multi-reader multi-case study," "number of experts," "adjudication method," etc.) are not applicable in the context of an in-vitro diagnostic (IVD) assay comparison study. The study described focuses on analytical performance rather than diagnostic accuracy involving human interpretation.

Acceptance Criteria and Study Details for INNOFLUOR™ Topiramate Control Set

Based on the provided 510(k) summary, the device under review is the INNOFLUOR™ Topiramate Control Set, which is part of the INNOFLUOR™ Topiramate Assay System. The study described focuses on establishing the analytical performance and substantial equivalence of the overall INNOFLUOR™ Topiramate Assay System, not specifically the control set in isolation, but rather its performance in measuring topiramate.

1. Table of Acceptance Criteria and Reported Device Performance

   The document implies acceptance criteria through the reference to "substantial equivalence" and the presentation of a linear regression analysis. While explicit numerical acceptance criteria (e.g., minimum correlation coefficient, maximum bias) are not stated, the demonstration of equivalency is the overarching criterion.

   Acceptance Criteria (Implied)	Reported Device Performance
   Substantial equivalence to current predicate devices/methods.	The technological characteristics, performance and intended use of the INNOFLUOR™ Topiramate Assay System are substantially equivalent to the INNOFLUOR™ Phenobarbital Assay System and the Abbott Phenobarbital II Assay with the exception of the specific anticonvulsant tested for by each method.
   Equivalency of results between INNOFLUOR™ Topiramate Assay System and an established method (Topiramate Gas Chromatography). Demonstrated by strong correlation and acceptable linear regression parameters.	Comparison of the patient sample results by linear regression analysis resulted in the regression equation: (INNOFLUOR™) = 0.985 x (GC) - 0.147, with a correlation coefficient of 0.9934, demonstrating equivalency of results. A correlation coefficient (r) of 0.9934 indicates a very strong linear relationship between the two methods. A slope of 0.985 is very close to 1, and an intercept of -0.147 is very close to 0, suggesting minimal systematic bias between the two methods.

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

   • Sample Size: 117 patient samples.
   • Data Provenance: The origin of the data (country) is not specified. It is prospective in the sense that samples were collected from "patients receiving topiramate therapy" and then analyzed by both methods for comparison. It is not listed as retrospective.

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

   • Not applicable. This study involves comparing the analytical measurement of a specific analyte (topiramate) by two different laboratory methods (fluorescence polarization immunoassay vs. gas chromatography). It does not involve human interpretation of images or other data where experts establish a diagnostic ground truth. The "ground truth" here is effectively the measurement obtained by the established reference method (Gas Chromatography).

4. Adjudication Method for the Test Set

   • Not applicable. See point 3.

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

   • No. This is an analytical performance study of an in-vitro diagnostic assay, not a study of an AI system for diagnostic image interpretation or similar.

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

   • Yes, analogous to standalone. The study directly compares the results of the INNOFLUOR™ Topiramate Assay System (algorithm/assay only) against Topiramate Gas Chromatography (reference method), without any human interpretive element being evaluated in the comparison. The "performance" being assessed is the analytical output of the assay system itself.

7. The Type of Ground Truth Used

   • The "ground truth" for the test set was established by Topiramate Gas Chromatography (GC). GC is a well-established and highly accurate analytical method often used as a reference standard for drug quantification.

8. The Sample Size for the Training Set

   • Not explicitly stated in terms of a "training set" for an algorithm. For an IVD assay, method development involves internal studies (calibration, linearity, precision), but these are usually not referred to as "training sets" in the same way as machine learning. The 117 patient samples are specifically for the comparison/validation study.

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

   • Not explicitly applicable in the machine learning sense. For an IVD assay, "ground truth" during development would be established through a carefully controlled laboratory setting, using gravimetrically prepared standards and reference materials, and verified by highly accurate reference methods (like GC or LC-MS/MS). The document does not detail the development process, only the validation comparison.

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The SYNCHRON Systems 10 ng/mL and 40 ng/mL THC Urine Controls, in conjunction with the SYNCHRON Cannabinoid 20 ng (THC2) Reagent, are intended for use on SYNCHRON Systems for monitoring the quality control of cannabinoid (THC) testing in the clinical laboratory. These controls are designed for use with the family of SYNCHRON Systems which include analyzers such as the SYNCHRON CX4, CX®4CE, CX4 DELTA, CX5, CX5CE, CX5 DELTA, CX7, CX7 DELTA Systems and LX™20 Systems.

The SYNCHRON® Systems 10 ng/mL and 40ng/mL THC Urine Controls, are ready-to-use, human urine based liquid controls designed to be used as part of a laboratory total quality management program to ensure proper THC assay performance. These controls complement the current panel of Cannabinoid reagents and controls previously cleared by the FDA. The kit consists of 1 x 5.0 mL bottle and must be stored at +2°C to + 8°C.

Table of Acceptance Criteria and Reported Device Performance:

Study Details:

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

   • Imprecision Study: 20 results for each control (Negative Calibrator, THC Control 1 (10 ng/mL), Low Calibrator (20 ng/mL), THC Control 2 (40 ng/mL), High Calibrator (50 ng/mL)).
   • Data Provenance: Not explicitly stated, but the study was conducted by Beckman Instruments, Inc. for their SYNCHRON® Systems controls, suggesting it's internal prospective data.

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

   • Not applicable. This device is a quality control material and the "ground truth" for its performance is inherent in its formulation and expected behavior, not established by expert interpretation.

3. Adjudication method for the test set:

   • Not applicable. The performance is based on analytical precision and stability measurements, not expert adjudication.

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

   • Not applicable. This is a quality control material for an immunoassay system, not an AI diagnostic tool that human readers would use or be assisted by.

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

   • Not applicable. This is a quality control material, not an algorithm. Its performance is evaluated through analytical studies.

6. The type of ground truth used:

   • For the imprecision study, the "ground truth" for the expected values of the controls and calibrators would be established during their manufacturing and formulation. The study measures the device's ability to consistently reproduce those expected values within acceptable limits.
   • For the stability study, the "ground truth" is the initial performance of the controls at the time of manufacture, and the study assesses how long they maintain that performance.

7. The sample size for the training set:

   • Not applicable. This device is a quality control material; there is no "training set" in the context of machine learning. The controls are manufactured to specific concentrations.

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

   • Not applicable. As there's no training set, there's no ground truth established for it. The ground truth for the performance studies is based on the known, manufactured concentrations and stability profiles of the control materials themselves.

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