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For in vitro diagnostic use to monitor the precision and the accuracy of the assayed, quantitative complexed PSA assays on the ADVIA® IMS and Bayer Immuno1® systems.

The Bayer ADVIA® IMS cPSA Controls are bovine serum based with non-serum constituents added. The analytes currently in the control material are: cPSA

This document is a 510(k) summary for the ADVIA® IMS cPSA Control, a quality control material. It describes the device, its intended use, and its substantial equivalence to a predicate device. As a quality control material used to monitor the performance of other assays, the acceptance criteria and study design are different from those for diagnostic devices that detect a disease. This document does not describe a clinical study in the typical sense with patient data, expert readers, or AI performance metrics.

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

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

The document does not explicitly state "acceptance criteria" in the context of performance specifications for the ADVIA® IMS cPSA Control itself. Instead, it describes its intended use as a quality control material "to monitor the precision and the accuracy of the assayed, quantitative complexed PSA assays on the ADVIA® IMS and Bayer Immuno1® systems."

The "reported device performance" of the ADVIA® IMS cPSA Control is implied by its function as a control. The key performance characteristics for such a control material would typically be its assigned values (which establish accuracy) and its stability (which ensures its continued utility for precision monitoring over time). However, these specific values or stability data are not provided in this summary.

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

This information is not applicable and not provided. The device is a quality control material, not a diagnostic device that processes patient samples or generates diagnostic data. There is no "test set" in the sense of patient 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)

This information is not applicable and not provided. As explained above, there is no "test set" of patient data requiring expert-established ground truth. The "ground truth" for a quality control material would be its manufacturing specifications and assigned analyte values, determined through laboratory methods, not expert consensus on patient cases.

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

This information is not applicable and not provided for the same reasons as above.

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

This information is not applicable and not provided. This device is a quality control material, not an AI-powered diagnostic tool, and therefore no MRMC study or AI-related effectiveness study was performed or is relevant.

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

This information is not applicable and not provided. This device is a quality control material, not an algorithm.

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

For a quality control material, the "ground truth" refers to its assigned analyte values (in this case, cPSA concentration) and its manufacturing specifications. These are established through rigorous laboratory testing during the development and manufacturing process, comparing it against reference materials and methods. The document does not detail how these specific values were established but implies they are part of the product specifications.

8. The sample size for the training set

This information is not applicable and not provided. This device is a quality control material, not a machine learning algorithm, and therefore has no "training set."

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

This information is not applicable and not provided for the same reasons as above.

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The Bayer ADVIA IMS® Glucose assay is an in vitro diagnostic device for use to measure glucose in human serum, plasma, urine and cerebrospinal fluid (CSF) on the ADVIA IMS® System. Such measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus and neonatal hypoglycemia.

The ADVIA IMS® Glucose method is based on the combination of hexokinase (HK) and glucose-6-phosphate dehydrogenase (G6PD) for the specific measurement of glucose in serum, plasma, urine and cerebral spinal fluid.

Here's an analysis of the provided 510(k) summary, structured to answer your questions regarding acceptance criteria and the study proving device performance:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the comparison to the predicate device and the presented performance characteristics. The study demonstrates comparable performance in terms of imprecision and correlation to the predicate device.

2. Sample Size and Data Provenance

• Test Set Sample Size: 64 CSF samples were used for the CSF correlation study. The sample sizes for the imprecision studies are not explicitly stated as a single number but are implied by the "Within-run CV" and "Total CV" which typically involve multiple runs and replicates.
• Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective).

3. Number of Experts and Their Qualifications for Ground Truth

This information is not applicable and therefore not provided. The study compares the performance of a new in vitro diagnostic device to a legally marketed predicate device, not against human expert interpretation of images or other subjective assessments. The "ground truth" here is the measurement obtained from the predicate device.

4. Adjudication Method for the Test Set

Not applicable. This is a comparison between two quantitative diagnostic devices, not a study involving human interpretation requiring adjudication.

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

No. This study is for an in vitro diagnostic device (glucose assay), not an AI algorithm assisting human readers in diagnostic interpretation. Therefore, an MRMC study is not relevant.

6. Standalone (Algorithm Only) Performance Study

Yes, in a sense. The entire submission describes the standalone performance of the ADVIA IMS Glucose assay in comparison to the predicate device. There is no human-in-the-loop component for the measurement of glucose in this context.

7. Type of Ground Truth Used

The "ground truth" for the performance evaluation is the quantitative measurement obtained from the predicate device, the Bayer ADVIA 1650 Glucose Hexokinase II. The study aims to demonstrate substantial equivalence by showing that the new device's measurements correlate strongly with those of the predicate.

8. Sample Size for the Training Set

Not applicable. This is an in vitro diagnostic device based on established biochemical principles (hexokinase and G6PD), not an AI algorithm that requires a "training set" in the machine learning sense. The device is developed and validated through analytical studies, not trained on data.

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

Not applicable, as there is no "training set" for this type of IVD device. The method relies on well-understood chemical reactions.

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The Bayer ADVIA IMS Lithium (LITH) method is an in vitro diagnostic device intended to measure lithium in human serum and plasma. Such measurements are used as an aid in the treatment of bipolar disorder.
The Bayer ADVIA IMS Lithium (LITH) method is an in vitro diagnostic device intended to measure lithium in human serum and plasma. Such measurements are used as an aid in monitoring lithium levels during the treatment of bipolar disorder.
The Assayed Chemistry Control 1 and Control 2 are for in vitro diagnostic use to monitor the performance of chemistry systems, including the ADVIA® IMS, ADVIA® Chemistry, and Technicon RA® and opeRA systems.
The Chemistry Calibrator is for in vitro diagnostic use in the calibration of chemistry assays on chemistry systems, including the ADVIA® IMS, ADVIA® Chemistry, and Technicon RA® and opeRA systems.

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Here's a breakdown of the acceptance criteria and study information for the Bayer ADVIA IMS Lithium method, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device and provides performance data rather than explicit pre-defined "acceptance criteria" in a go/no-go fashion. However, we can infer performance targets or expectations based on the predicate device's performance and the regression analysis.

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

• Sample Size for Correlation Studies: 49 samples (N=49) for both the comparison with CDC Flame and ThermoTrace systems.
• Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It is a 510(k) submission, which typically involves internal validation testing by the manufacturer. Assuming typical practices, the samples were likely collected prospectively for the purpose of the study, and the origin is probably related to the manufacturer's testing facilities (e.g., within the US or a region where Bayer operates).

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

• None applicable. This is an in vitro diagnostic device for measuring a chemical analyte (Lithium). "Ground truth" for clinical decisions or image interpretation by experts is not relevant here. The ground truth for the comparison studies is established by reference methods or predicate devices (CDC Flame, ThermoTrace).

4. Adjudication Method for the Test Set:

• None applicable. As detailed in point 3, there are no "experts" in the sense of clinical decision-makers adjudicating results. The comparison methods act as the reference.

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

• No. An MRMC study is not relevant for this type of in vitro diagnostic device, which directly measures a chemical concentration rather than assisting human readers in interpreting complex diagnostic information (like medical images).

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

• Yes. The entire submission details the standalone performance of the ADVIA IMS Lithium method. The "device" is the algorithm/system for measuring lithium. There isn't a human-in-the-loop component in the measurement process itself, although a human interprets the numerical results for patient management. The data presented for imprecision, correlation, and interference are all standalone performance metrics.

7. The Type of Ground Truth Used:

• Reference Method/Predicate Device Measurements:
  • For the correlation study with "Comparison System (X) CDC Flame," the ground truth for lithium concentration was established by the Centers for Disease Control (CDC) Flame Photometer, which is a recognized reference method.
  • For the correlation study with "Comparison System (X) ThermoTrace," the ground truth was established by the predicate device, the ThermoTrace Lithium method.
  • For imprecision and interference studies, the ground truth is often established by precise gravimetric or volumetric preparation of known concentrations, confirmed by a reference method.

8. The Sample Size for the Training Set:

• Not explicitly stated/not applicable in the same way as AI/ML. This device is a traditional immunoassay system, not an AI/Machine Learning algorithm that requires a "training set" in the common sense for model development. The development process would involve method development, reagent formulation, and analytical validation rather than machine learning training.

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

• Not applicable. As described above, this is a traditional in vitro diagnostic assay, not an AI/ML system requiring a training set with established ground truth labels for learning. The "ground truth" during development would be based on known chemical concentrations and performance against established analytical standards.

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This in vitro method is intended to quantitatively measure HDL Cholesterol in human serum and plasma on the Bayer ADVIA® IMS systems. Measurements of HDL Cholesterol are used in assessing cardiovascular risk.

The Bayer ADV/A IMS Direct HDL Cholesterol (D-HDL) method is for in vitro diagnostic use to measure HDL Cholesterol in human serum and plasma. Such measurements are used in the risk assessment of cardiovascular diseases.

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Here's a breakdown of the acceptance criteria and study information for the Direct HDL Cholesterol Method for ADVIA® Modular System (IMS), based on the provided 510(k) summary:

Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly state numerical "acceptance criteria" values (e.g., "CV must be < X%"). Instead, it presents the performance of the new device (ADVIA IMS) and compares it to a legally marketed predicate device (ADVIA 1650). The implicit acceptance criterion is that the new device's performance is comparable to or better than the predicate device. For the correlation study, the strong R-value, a slope near 1, and an intercept near 0, along with a low Syx, suggest good agreement. The provided table includes the performance of the predicate device (ADVIA 1650) for comparison.

Study Details

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

   • Sample Size: 100 specimens for the correlation study (serum).
   • Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective). However, it's typically assumed to be a controlled laboratory study conducted to support regulatory submission.

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

   • This is a quantitative assay, not an interpretive imaging or diagnostic device requiring expert consensus for ground truth. The "ground truth" is established by the comparative system (ADVIA 1650) which is a legally marketed device for the same measurement, or by a reference method which is not explicitly stated as distinct from the predicate device.

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

   • Not applicable as this is a quantitative analytical measurement, not a subjective interpretation requiring 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 device is an in vitro diagnostic (IVD) assay for measuring a biomarker (HDL Cholesterol), not an AI-powered diagnostic imaging tool or a system involving human interpretation.

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

   • Yes, this is a standalone device performance study. The measurements are performed by the ADVIA IMS system without human interpretive input for the result generation. Human operators would load samples and review results, but the analytical measurement itself is automated.

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

   • The "ground truth" for the correlation study is the measurements obtained from the predicate device, ADVIA 1650. For an IVD, the standard method for establishing accuracy (or substantial equivalence in this context) is comparison to a legally marketed predicate device or a recognized reference method.

7. The sample size for the training set:

   • Not applicable in the context of this 510(k) submission. This device is a chemical assay, not a machine learning or AI model that requires a distinct "training set" in the computational sense. The development of the assay itself would involve optimization and calibration, but not a "training set" like an AI algorithm.

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

   • Not applicable, as there isn't a "training set" in the AI sense. The development and calibration of the assay would rely on established analytical chemistry principles and reference materials, but this distinction isn't made in the document.

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This in vitro method is intended to quantitatively measure the antiepileptic drug valproic acid in human serum and plasma on the Bayer ADVIA® IMS systems. Measurements of valproic acid are used to aid in monitoring therapeutic levels of valproic acid to ensure appropriate therapy and in the treatment of valproic acid overdose.
The Bayer ADVIA IMS Valproic Acid method is for in vitro diagnostic use to measure the antiepileptic drug valproic acid in human serum and plasma. Measurements of valproic acid (2-propylpentanoic acid) are used as an aid in the diagnosis and treatment of valproic acid overdose, and in monitoring therapeutic levels of valproic acid to ensure appropriate therapy.

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1. Acceptance Criteria and Reported Device Performance

Study Proving Acceptance Criteria:

The provided document describes a validation study comparing the performance of the ADVIA® IMS Valproic Acid Method to a predicate device, the Bayer Centaur Valproic Acid method. The study design is a comparative effectiveness study demonstrating substantial equivalence rather than explicitly listing acceptance criteria targets. The "acceptance criteria" are implied by showing performance that is either equivalent or superior to the legally marketed predicate device across various metrics.

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

• Sample Size for Test Set:
  • Correlation Study: N = 50 (specimens)
  • Minimum Detectable Concentration: Multiple measurements to determine the detection limit.
  • Imprecision: Not explicitly stated as a number of patient samples, but "Level" indicates control or spiked samples were likely run repeatedly.
  • Interfering Substances: Not explicitly stated as a number of patient samples, but specific concentrations of interferents were used with a valproic acid concentration.
• Data Provenance: Not explicitly stated in the provided text. It is a submission by Bayer Corporation, so the data is likely generated in a regulated environment for a diagnostic product. The document does not specify the country of origin of the data or whether it was retrospective or prospective.

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

This is a study for an in vitro diagnostic (IVD) device that measures a chemical analyte (valproic acid) quantitatively. The "ground truth" for such devices is established by reference methods or established analytical techniques, often using certified reference materials or highly accurate comparative methods.

• Experts: Not applicable in the sense of clinical experts interpreting images or patient conditions. The "ground truth" is analytical.
• Qualifications: The "expert" in this context is the predicate device and its established analytical performance. The comparison system (Centaur) acts as the reference for determining correlation.

4. Adjudication Method for the Test Set:

Not applicable. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies where human interpretation of ambiguous data (like medical images) requires consensus among experts. For a quantitative IVD device like this, the "data" are numerical results, and the comparison is statistical.

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

No, an MRMC study was not done. MRMC studies are used to evaluate human reader performance, often with and without AI assistance, in interpreting clinical cases (e.g., radiology images). This document describes the performance of an automated analytical method on an in vitro test, not a human interpretation task.

Effect Size: Not applicable, as no MRMC study was performed.

6. Standalone Performance Study:

Yes, a standalone performance study was done. The entire document describes the standalone performance of the ADVIA IMS Valproic Acid method in terms of its analytical characteristics (MDC, imprecision, correlation, interference, analytical range) when compared against or measured relative to a predicate device and known standards. The "algorithm" is the reagent and instrument system, and its performance is evaluated without human intervention in the measurement process itself. The readings produced by the device are the output being evaluated.

7. Type of Ground Truth Used:

The ground truth used for this quantitative measurement device is primarily:

• Comparison to a Legally Marketed Predicate Device (Centaur): For correlation studies, the results from the Centaur system serve as the comparative reference.
• Known Concentrations/Standards: For MDC, imprecision, and interference studies, presumably, samples with known, controlled valproic acid concentrations (e.g., spiked samples, control materials) were used.
• This falls under the category of analytical validation against established methods and reference materials, rather than pathology or complex outcomes data.

8. Sample Size for the Training Set:

The document does not provide information on a "training set" or its sample size. This is common for IVD devices that rely on established chemical reactions and optical/electrical detection rather than machine learning algorithms that require explicit training data. The "training" for such a system would involve optimizing reagent formulations and instrument calibration procedures, but not in the sense of a machine learning model.

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

As there is no mention of a "training set" in the context of machine learning, this question is not applicable. For a traditional IVD device, the "ground truth" for establishing methods and calibrating instruments would be based on:

• Reference Methods: Using highly accurate and validated analytical techniques to assign values to calibrators and controls.
• Certified Reference Materials: Using materials whose valproic acid concentrations are traceable to international standards.
• Method Development and Optimization: The design and chemical properties of the reagents, along with instrument parameters, are developed based on known chemical principles and extensive testing during the R&D phase to ensure accurate measurement across the analytical range.

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The Bayer ADVIA IMS Carbamazepine method is for in vitro diagnostic use to measure the antiepileptic drug carbamazepine in human serum and plasma. Measurements of carbamazepine are used as an aid in the diagnosis and treatment of carbamazepine overdose, and used as an aid in monitoring therapeutic levels of carbamazepine to ensure appropriate therapy.

The Bayer ADVIA IMS Carbamazepine calibrator is for in vitro diagnostic use in the calibration of carbamazepine using the ADVIA® IMS system.

This in vitro method is intended to quantitatively measure the antiepileptic drug carbamazepine in human serum and plasma on the Bayer ADVIA® IMS systems.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as numerical thresholds in the provided document, but are implied by demonstrating performance that is comparable to or better than the predicate device and showing minimal impact from interfering substances. The ADVIA IMS device generally shows better or comparable performance to the Bayer Centaur predicate device across the measured metrics.

2. Sample Size and Data Provenance for the Test Set

• Sample Size for Correlation Study: 48 serum specimens were used for the correlation study against the Centaur comparison system.
• Data Provenance: The document does not explicitly state the country of origin or if the data was retrospective or prospective. It is implied to be from a laboratory setting.

3. Number of Experts and Qualifications for Ground Truth

• This type of in-vitro diagnostic device (IVD) for quantitative measurement does not typically involve expert review for ground truth in the same way imaging or diagnostic algorithms do. The "ground truth" for these studies is the measurement obtained from a well-established, often predicate, device or a reference method. Therefore, the concept of "number of experts" and their "qualifications" for establishing ground truth is not applicable here.

4. Adjudication Method for the Test Set

• Adjudication methods (like 2+1, 3+1) are typically used in studies involving subjective interpretation, often in imaging or clinical trials. For a quantitative IVD device like this, the performance is assessed against a numerical "reference standard" or a predicate device. Therefore, no adjudication method was used or needed in the traditional sense.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This type of study is relevant for diagnostic devices where human readers interpret results, and the AI's impact on their performance is being evaluated. This device is a quantitative automated assay, so human interpretation in the same manner as an imaging study is not involved.

6. Standalone (Algorithm Only) Performance Study

• Yes, the performance data presented (MDC, Imprecision, Correlation, Interfering Substances, Analytical Range) represents the standalone performance of the ADVIA IMS Carbamazepine method. It is an automated system, and these metrics directly reflect its capabilities without human intervention in the measurement process.

7. Type of Ground Truth Used

• The ground truth for this study was established using a comparison system, specifically the Bayer Centaur. For the correlation study, the measurements from the Centaur system served as the reference standard against which the ADVIA IMS system was evaluated. For other metrics like MDC and Imprecision, the reference for "truth" comes from established analytical methods and statistical calculations within the laboratory environment.

8. Sample Size for the Training Set

• The document does not provide information on the sample size used for the training set. This information is typically proprietary to the manufacturer and not always included in 510(k) summaries, especially for established IVD technologies.

9. How Ground Truth for the Training Set Was Established

• The document does not provide information on how the ground truth for the training set was established. For quantitative IVDs, the "training" (calibration and optimization) of the assay would typically involve using known concentration standards (calibrators) and reference materials with established values. These standards are rigorously prepared and validated.

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