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For in vitro diagnostic use in the control of ADVIA Chemistry systems for certain chemistry methods.

The Bayer Special Chemistry Controls are two separate levels of quality control material prepared from human serum with nonserum constituents added.

All the analytes currently in the control material are: Acid Phosphatase Lactate Pancreatic Amylase Lipase Cholinesterase Direct TIBC The intention of this submission is to add the assigned values to the labeling claims for: Direct TIBC

The provided text is a summary of a 510(k) premarket notification for a medical device: "Bayer ADVIA Chemistry Special Chemistry Control Quality Control Material." It is important to note that this document is for a quality control material, not a diagnostic device that directly analyzes patient samples. Therefore, the typical "acceptance criteria" and "study" framework for a diagnostic device (e.g., sensitivity, specificity, clinical outcome studies) does not directly apply in the same way.

The "study" here is essentially the demonstration of substantial equivalence to a legally marketed predicate device, with the addition of a new analyte, Direct TIBC, to the control material's labeling claims.

Here's an analysis of the provided information within the context of a quality control material:

1. Table of Acceptance Criteria and Reported Device Performance

For quality control materials, acceptance criteria typically revolve around the stability and accuracy of the assigned values for the analytes. The "performance" is the successful establishment of these assigned values and the demonstration that the material functions as intended for monitoring analytical systems.

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

The concept of a "test set" in the context of clinical performance (like patient samples) is not directly applicable here. The "test" for this quality control material involves establishing the assigned values for the various analytes, particularly the newly added Direct TIBC.

• Sample Size: Not explicitly stated as a "sample size" in relation to a patient cohort. For quality control materials, this usually refers to the number of lots or runs used to establish the target values and ranges. The document states "The intention of this submission is to add the assigned values to the labeling claims for: Direct TIBC." This implies that internal studies were conducted by Bayer to determine these assigned values experimentally.
• Data Provenance: Not specified in the document. It's internal data generated by the manufacturer during the development and validation of the quality control material. Given the manufacturer's location, the data would likely originate from their facilities (e.g., Tarrytown, NY, or Randox Laboratories in the UK). This would be prospective data generation for the purpose of establishing the control material's characteristics.

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

This type of information (number of experts, their qualifications, and adjudication) is typically relevant for studies involving subjective interpretation of patient images or complex diagnostic results. It is not applicable to the establishment of assigned values for a chemistry quality control material.

The "ground truth" for a quality control material's assigned values is established through rigorous analytical testing using reference methods or highly characterized instruments, often in multiple laboratories.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

As explained above, an adjudication method in the sense of expert consensus for subjective interpretation is not applicable to this type of device and its "test set." The determination of assigned values is based on analytical measurements and statistical analysis.

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 type of study is relevant for AI-powered diagnostic devices that assist human readers. This device is a quality control material for chemistry analyzers, not an AI-assisted diagnostic tool. Therefore, an MRMC study is not applicable.

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

This refers to the performance of an AI algorithm without human involvement. Since this is a quality control material and not an AI algorithm, a standalone performance study in this context is not applicable.

7. The Type of Ground Truth Used

For a quality control material, the "ground truth" for the assigned values is established through:

• Reference Methods: Often, the performance of the control material is assessed against highly accurate reference methods or primary calibrators.
• Target Value Assignment: This typically involves running the control material on multiple analytical instruments (often of the same type for which the control is intended) over a period of time, using validated methods, and then statistically determining the mean and acceptable ranges for each analyte. This is an analytical ground truth.
• In this specific case, the "ground truth" for the added Direct TIBC would have been established by performing assays for Direct TIBC using the designated Bayer Chemistry Analyzers and statistically determining the target values and ranges for the control material levels.

8. The Sample Size for the Training Set

The concept of a "training set" is primarily associated with machine learning or AI algorithms. As this is a quality control material, a "training set" in that sense is not applicable.

Instead, the "development" or "characterization" of the control material involves thorough analytical testing. The "sample size" here would refer to the number of vials, lots, or analytical runs used to establish the assigned values. This information is not provided in the summary but would be part of the manufacturer's internal validation data.

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

Since there is no "training set" in the AI sense for this device, how its "ground truth" (assigned values) was established is described in point 7. It involves analytical testing and characterization of the control material using accepted laboratory practices and statistical methods to determine the target values and acceptable ranges for each analyte on the intended analytical platforms.

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For in vitro diagnostic use in the calibration of the ADVIA 1650 Chemistry system for certain chemistry methods.

The Bayer Special Chemistry Calibrators are for one absolute value of calibrator material prepared in human serum with nonserum constituents added. All the analytes currently in the calibrator material are: Acid Phosphatase Lactate Lipase Direct TIBC. The intention of this submission is to add the assigned values to the labeling claims for: Direct TIBC. As with the predicate device, the calibrator materials are lyophilized and require reconstitution with 5.0 mL distilled water. These calibrators are only for use on the Bayer ADVIA 1650 Chemistry Analyzer.

The provided text describes a submission for a Special Chemistry Calibrator from Bayer Healthcare LLC. It focuses on regulatory approval (510(k)) and states that the device is substantially equivalent to a previously cleared predicate device. The key difference in this submission is the addition of assigned values for "Direct TIBC" to the labeling claims.

However, the document does not contain the detailed acceptance criteria or a study proving the device meets those criteria, as typically requested in your prompt. The document is a regulatory submission for premarket notification, establishing substantial equivalence based on the device's similarity to an existing one, rather than presenting a detailed performance study with acceptance criteria.

Therefore, I cannot provide the requested information. The document explicitly states:

• No acceptance criteria: The document does not define specific performance metrics or acceptance criteria for the "Direct TIBC" calibration.
• No study proving acceptance criteria: Since no acceptance criteria are given, there is no study described that proves the device meets them. The basis for approval is substantial equivalence to a predicate device.
• No sample sizes, data provenance, expert details, adjudication methods, MRMC studies, or standalone performance details: These are all elements of a detailed performance study, which is not present in this 510(k) summary. The nature of the submission focuses on demonstrating equivalence, not on extensive de novo performance testing against new criteria.
• Type of ground truth, training set size, and ground truth establishment for the training set: These details are also absent as no new substantial performance study is being presented. The device is a calibrator, and its "ground truth" would be related to its assigned values and stability, which are stated to be similar to the predicate device.

The main points from the document pertinent to its "performance" (as understood in a regulatory context for this type of device) are:

• Device Name: Special Chemistry Calibrator
• Proprietary/Trade Name: Bayer ADVIA 1650 Special Chemistry Calibrator
• Intended Use: Calibrators for in vitro diagnostic use to monitor the precision and accuracy of certain chemistry test procedures for the ADVIA 1650 Chemistry analyzer.
• Key Change: Addition of assigned values to the labeling claims for "Direct TIBC".
• Substantial Equivalence: The device is stated to be "identical in intended use, storage and handling, stability, source material (human serum), and instructions for use as the previously cleared Special Chemistry Calibrators." The only difference is the added analyte value for Direct TIBC.

Due to the nature of the provided text, which is a 510(k) summary focused on substantial equivalence rather than a detailed performance study, I cannot extract the specific information requested in your prompt regarding acceptance criteria and a proving study.

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The ADVIA IMS® Digoxin method is for in vitro diagnostic use to quantitatively measure digoxin, a cardioactive drug, in human serum. Measurements obtained are used as an aid in the diagnosis of digoxin overdose and in monitoring therapeutic levels of digoxin to ensure appropriate therapy.

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The Bayer ADVIA IMS® Digoxin assay is intended for in vitro diagnostic use to quantitatively measure digoxin, a cardioactive drug, in human serum. This product is used as an aid in diagnosing digoxin overdose and monitoring therapeutic levels of digoxin for appropriate therapy.

Here's an analysis of the provided information regarding the acceptance criteria and the study proving the device meets these criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" with numerical thresholds for performance metrics. However, the study aims to demonstrate substantial equivalence to the predicate device, the Immuno 1 Digoxin Assay. Therefore, the "reported device performance" is compared directly against the predicate device's performance, implying that performance comparable to or better than the predicate is the de facto acceptance criterion.

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The Bayer ADVIA Chemistry Alpha-1-antitrypsin assay is an in vitro diagnostic device intended to quantitatively measure Alpha-1-antitrypsin concentration in human serum and plasma on the ADVIA® Chemistry system. Measurement of alpha-1-antitrypsin levels aid in the diagnosis of juvenile and adult cirrhosis of the liver. In addition, alpha-1-antitrypsin deficiency has been associated with pulmonary emphysema.

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Here's an analysis of the provided text, focusing on acceptance criteria and the study proving device performance:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria with specific numerical thresholds for performance metrics. Instead, it presents performance data for the new device alongside a predicate device (Roche) for comparison (for imprecision) and reports correlation with another comparison system (Hitachi) without direct acceptance values. The "acceptance" can be inferred by the FDA's clearance, which implies the device's performance was deemed substantially equivalent to a legally marketed predicate.

However, we can infer some criteria from the data provided:

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

• Imprecision: Not explicitly stated, but typically involves multiple replicates over several runs. The levels noted (e.g., 91.83 ug/dL) likely represent specific control or patient samples tested multiple times.
• Correlation:
  • Sample Size: N = 44 (for serum specimens)
  • Data Provenance: Not explicitly stated (e.g., country of origin). It is retrospective as these are existing samples being tested on two different systems.
• Interference: Not explicitly stated, but based on the table, 5 different interfering substances were tested. For each substance, it appears one AAT concentration was spiked with the interferent.
• Analytical Range: Not explicitly stated, but typically involves testing a series of diluted and concentrated samples to determine linearity.

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

This type of in vitro diagnostic device (IVD) for quantitative measurement of a biomarker does not rely on expert interpretation for ground truth in the same way an imaging AI or diagnostic algorithm might.

• For Imprecision, the "ground truth" is the established reference value of the control material or the sample's true concentration, measured meticulously in a laboratory setting.
• For Correlation, the "ground truth" for the comparison is the measurement obtained from the chosen comparison system (Hitachi AAT in this case).
• For Interference, the "ground truth" is the known concentration of alpha-1-antitrypsin in the sample before the interferent is added.
• For Analytical Range, the "ground truth" is the known concentration of standard solutions or diluted samples.

Therefore, the concept of "experts establishing ground truth" as it applies to diagnostic interpretation is not relevant here. The ground truth is inherent in the chemical and analytical properties of the samples and the established reference methods.

4. Adjudication Method for the Test Set

Not applicable. As explained above, this is a quantitative measurement, not a diagnostic interpretation that requires adjudication among 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

Not applicable. This is an in vitro diagnostic assay (a laboratory test), not an AI-assisted diagnostic imaging or interpretation system that involves human readers.

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

Yes, the studies presented (imprecision, correlation, interference, analytical range) reflect the standalone performance of the device/method (Bayer ADVIA Chemistry Alpha-1-antitrypsin assay). This device is an automated chemical analyzer component, and its "performance" is its ability to accurately and precisely measure the analyte without human interpretive intervention.

7. The Type of Ground Truth Used

• For Imprecision: Reference material values or meticulously measured sample concentrations.
• For Correlation: Measurements from a predicate/comparison device (Hitachi AAT).
• For Interference: Known spiked concentrations and baseline measurements of the unspiked sample.
• For Analytical Range: Gravimetrically or volumetrically prepared standard solutions.

8. The Sample Size for the Training Set

Not applicable in the context of an IVD assay's analytical validation. This device is not an AI/ML model that requires a distinct "training set." The development of the assay (e.g., reagent formulation, assay parameters) would involve extensive R&D and optimization, but not a "training set" in the machine learning sense. The data presented are for verification and validation of the final assay.

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

Not applicable, as there's no "training set" in the AI/ML context for this type of device. The accuracy of the assay itself is validated against established analytical principles and reference methods.

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The Bayer ADVIA IMS Uric Acid (UA) method is an in vitro diagnostic device intended to measure uric acid in human serum, plasma and urine. Such measurements are used as an aid in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation and other wasting conditions and of patients receiving cytotoxic drugs.

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

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary directly presents performance data for the ADVIA IMS Uric Acid method and compares it to a predicate device (ADVIA 1650 Uric Acid) and/or a comparison system (CDC Uricase). While explicit "acceptance criteria" are not stated as defined thresholds (e.g., "CV must be less than X%"), the reported performance demonstrates "substantial equivalence" to the predicate, implying that these levels of performance were acceptable for clearance.

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

The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective.

• Imprecision Study (Serum): The "Level (mg/dL)" values suggest multiple measurements were taken at three different concentrations, but the exact number of replicates or individual samples is not provided.
• Imprecision Study (Urine): Similar to serum, the exact number of replicates or individual samples is not provided.
• Correlation Studies:
  • Serum vs. CDC Uricase: N = 117
  • Serum vs. Advia 1650: N = 100
  • Plasma (Y) vs. Serum (X) with Advia 1650: N = 54
  • Urine vs. CDC Uricase: N = 10
  • Urine vs. Advia 1650: N = 63
• Interfering Substances: The Uric Acid Conc. (mg/dL) values suggest testing at specific concentrations, but the number of samples for each interferent is not provided.

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

This information is not provided in the 510(k) summary. For in vitro diagnostic devices like this, "ground truth" is typically established by reference methods or validated comparative systems (e.g., CDC Uricase), rather than by human expert consensus or pathology review in the same way it would be for an imaging-based AI device.

4. Adjudication Method for the Test Set

This is not applicable for this type of in vitro diagnostic device study. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation (e.g., radiology reads) to resolve discrepancies.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI devices that assist human diagnosticians (e.g., CAD systems for radiology). The ADVIA IMS Uric Acid method is a standalone laboratory instrument for quantitative measurement, not an AI assisting human readers.

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

Yes, the studies presented are standalone performance studies of the ADVIA IMS Uric Acid method. The device measures uric acid levels automatically; there is no "human-in-the-loop" once the sample is loaded and the test initiated. The performance metrics (imprecision, correlation, interference) directly reflect the algorithm's and instrument's capabilities.

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

The ground truth for the test set was established using:

• Reference Methods: The "CDC Uricase" method is cited as a comparison system for correlation studies in both serum and urine. This is a highly accurate and standardized reference method for uric acid measurement.
• Predicate Device/Comparative System: The "Advia 1650" (the predicate device) was used as a comparison system for imprecision, correlation, and for comparing plasma vs. serum. This indicates that the performance of the new device was benchmarked against an already legally marketed and accepted method.

8. The Sample Size for the Training Set

This is not applicable in the context of this device. The ADVIA IMS Uric Acid method is an enzymatic assay based on established biochemical principles, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. Its performance is characterized through analytical validation studies using patient samples and quality controls, which are the "test sets" described above.

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

As mentioned above, this is not applicable because the device does not employ machine learning or AI that would necessitate a "training set" with ground truth established through, for example, expert annotation. The device's underlying chemistry and optical detection principles are well-understood and do not require iterative training.

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Assayed control material for in vitro diagnostic use to monitor the precision and accuracy of immunochemistry test procedures for the ADVIA Centaur® andACS:180® Systems.

The Ligand Plus 1, 2, 3 Controls are three separate levels of quality control material prepared from human serum with non-serum constituents added. The analytes currently in the control material are: Alphafetoprotein, Carbamazepine, CEA, Digoxin, Cortisol, Gentamicin, Estradiol, Phenobarbital, Ferritin, Phenytoin, Folic Acid, Theophylline, FSH, Tobramycin, HCG, Valproic Acid, IgE, Vancomycin, LH, Progesterone, Prolactin, PSA, T3, T3-free, T4, T4-free, Testosterone, Thyroid Uptake, TSH, TSH-3, Vitamin B12. The intention of this submission is to add the following three constituents to the existing control: Intact PTH (iPTH, or intact parathyroid hormone), Insulin, c-Peptide.

Here's a breakdown of the acceptance criteria and study information based on the provided text, focusing on the absence of detailed performance data as this is a Class I device and the submission primarily concerns adding new analytes to an existing control.

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary for the Ligand Plus 1, 2, 3 Controls does not include a table of specific numerical acceptance criteria or reported device performance metrics (e.g., accuracy, precision values, sensitivity, specificity).

This is primarily because:

• The device is a Class I quality control material, which typically requires demonstrating that it functions as intended (i.e., provides stable and accurate control values) rather than providing diagnostic results itself.
• The submission is for the addition of three new analytes (iPTH, Insulin, and c-Peptide) to an already cleared predicate device. The primary concern is that these new analytes integrate without compromising the control's known function.
• The "Substantial Equivalence" section emphasizes the identity of intended use, storage, handling, stability, source material, and instructions for use with the predicate device.

Instead of specific performance numbers, the "acceptance criteria" here would be demonstrating that the new analytes behave as expected for a quality control material and do not negatively impact the overall functionality or existing cleared analytes of the control. This would involve validation studies (which are generally not detailed in a Class I 510(k) summary in this manner) showing the control provides stable, reproducible results when run on the specified instruments.

For a quality control product, "performance" is typically demonstrated by:

• Target Value Assignment: Showing that the control can be assigned appropriate target values for the added analytes.
• Stability: Demonstrating the stability of the added analytes over the product's shelf-life.
• Lot-to-Lot Consistency: Ensuring consistency between different manufacturing lots.
• Matrix Effects: Confirming that the control matrix is suitable for the specified assays.

The document implicitly states that these aspects were successfully addressed to achieve substantial equivalence.

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

The 510(k) summary does not specify the sample size used for any test set or the data provenance (e.g., country of origin, retrospective/prospective). This level of detail is typically not required or provided in Class I 510(k) summaries for quality control materials for added analytes to an existing control. Demonstrating "substantial equivalence" for a control material often relies on internal validation studies and comparison to existing methods/materials rather than extensive clinical trial data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable and not provided.

• The device is a quality control material, not a diagnostic device that interprets patient samples. Therefore, "ground truth" as established by experts in clinical interpretation (e.g., radiologists, pathologists) is not relevant to its performance.
• Ground truth for a control material involves the accurate assignment of analyte concentrations (target values), which is determined by the manufacturer through rigorous analytical methods and reference measurements, not by expert consensus on clinical findings.

4. Adjudication Method for the Test Set

This information is not applicable and not provided for the same reasons as #3. Adjudication by experts is relevant for diagnostic devices interpreting complex clinical data, not for the analytical performance of a quality control material.

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

A MRMC comparative effectiveness study was not done. This type of study focuses on the impact of a diagnostic tool on human reader performance (e.g., radiologists, pathologists) in interpreting medical images or complex data. Since the device is a quality control material (for in vitro diagnostic use to monitor precision and accuracy of immunochemistry tests), human interpretation of results is not directly assessed in the way an MRMC study would measure. Its role is to ensure the analyzers are performing correctly.

6. Standalone Performance Study

While not explicitly called a "standalone performance study" in the context of diagnostic algorithms, the underlying studies to support the addition of the new analytes would involve standalone analytical performance evaluations of the control material itself. These studies would assess:

• Assigned values and expected ranges for iPTH, Insulin, and c-Peptide.
• Reproducibility (precision) of these analytes when measured on the ADVIA Centaur® and ACS:180® Systems.
• Stability of these analytes in the control matrix over time and under various storage conditions.
• Homogeneity within and between vials.

The positive outcome of these internal analytical studies would have formed the basis for the submission, allowing the FDA to deem the device "substantially equivalent."

7. Type of Ground Truth Used

The "ground truth" for a quality control material like this involves analytically derived target values and acceptable ranges for the analytes. These would be established by:

• Reference measurement procedures: Highly accurate and precise laboratory methods (often traceable to international reference materials).
• Interlaboratory studies: Testing the control material across multiple qualified laboratories to establish consensus values.
• Manufacturer's internal validation: Extensive testing using the intended platform (ADVIA Centaur® and ACS:180® Systems) to determine the expected values and performance characteristics.

This is not "expert consensus" in the clinical sense, nor is it based on pathology or outcomes data. It is purely analytical.

8. Sample Size for the Training Set

This information is not applicable and not provided. "Training set" refers to data used to train machine learning algorithms. This device is a biochemical control material, not an AI or machine learning-based diagnostic device.

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

This information is not applicable and not provided for the same reasons as #8.

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The Bayer ADVIA 1650 Acid Phosphatase assay is an in vitro diagnostic device intended to measure total and non-prostatic acid phosphatase concentrations in human serum.
The Bayer ADVIA 1650 Acid Phosphatase assay is an in vitro diagnostic device intended to quantitatively measure total and non-prostatic acid phosphatase concentration in human serum.

The ADVIA 1650 acid phosphatase method measures total and non-prostatic acid phosphatase in serum by a colorimetric procedure published by Hillmann. Tartrate inhibits prostatic acid phosphatase, allowing for measurement of non-prostatic acid phosphatase. The prostatic acid phosphatase concentration can be manually calculated by determining the difference between total acid phosphatase and non-prostatic acid phosphatase.

Here's a breakdown of the acceptance criteria and study information for the Bayer ADVIA® 1650™ Acid Phosphatase assay, based on the provided text:

Acceptance Criteria and Device Performance

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The Bayer ADVIA 1650 Ammonia method and calibrator is an in vitro diagnostic device intended to quantitatively measure ammonia levels in human plasma (heparin or EDTA). Such measurements are used in assessing hepatic function and diagnosis of Reye's syndrome.

The Bayer ADVIA 1650 Ammonia assay is an in vitro diagnostic device intended to quantitatively measure Ammonia levels in human plasma (heparin or EDTA).

The provided document describes the safety and effectiveness summary for the Bayer ADVIA® 1650™ Ammonia assay. This device is an in vitro diagnostic device used to quantitatively measure ammonia levels in human plasma. The information pertains to an analytical performance study rather than an AI/ML medical device. Therefore, several sections of the requested output (2, 3, 4, 5, 6, 7, 8, and 9) related to AI/ML and human experts are not applicable.

Here's the breakdown of the available information:

1. Table of Acceptance Criteria and the Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" but presents performance data for imprecision, correlation, and interfering substances, comparing the ADVIA 1650 to a predicate device (Roche Ammonia on Hitachi). The acceptance is implied by the presentation of the data itself against the predicate device's performance.

• 3.8% (at 69.7 ug/dL)
• 1.7% (at 150.6 ug/dL)
• 0.7% (at 387.9 ug/dL) |
  | Correlation | Strong linear correlation (r value close to 1) and low Syx compared to Roche (On Hitachi) | $Y = 1.05x + 7.19$
  (where Y = ADVIA 1650, X = Roche)
  Syx = 62.18
  r = 0.98 |
  | Interfering Substances Recovery | Recovery % should be within an acceptable range (typically 90-110% or similar) despite interferents | Hemoglobin: 105.18%
  Bilirubin conj: 95.30%
  Bilirubin unconj: 100.48%
  Intralipid: 91.06%
  TRIG Concentrate: 108.98% |
  | Analytical Range | 25 to 1300 ug/dL (This is the stated range, implying it meets internal criteria) | 25 to 1300 ug/dL (Serum/Plasma(Lithium heparin)) |

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 Correlation Test: 94 plasma specimens (N=94).
• Data Provenance: 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 the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is an analytical performance study of an in vitro diagnostic device, not an AI/ML medical device requiring expert ground truth for image interpretation or diagnosis. The "ground truth" (or reference method) for comparison is the predicate device's measurement.

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

Not applicable. This is an analytical performance study of an in vitro diagnostic device. Adjudication methods are relevant for subjective interpretations, typically in diagnostic imaging or clinical trials with human readers.

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

Not applicable. This is an analytical performance study of an in vitro diagnostic device, not an AI/ML assisted diagnostic tool.

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

Yes, the study describes the standalone analytical performance of the ADVIA 1650 Ammonia assay. The performance metrics (imprecision, correlation, interference) are inherent to the device's measurement capabilities.

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

The "ground truth" or reference for comparison in this analytical study is the measurements obtained from the predicate device, the Roche Ammonia assay (on Hitachi).

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no "training set" in the context of machine learning. The device is a chemical analyzer.

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

Not applicable. Refer to point 8.

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The Bayer ADVIA® IMS PSA assay is an in vitro diagnostic device intended to quantitatively measure prostate specific antigen (PSA) in human serum. This assay is indicated for the measurement of serum PSA as an aid in management (monitoring) of prostate cancer patients. PSA values obtained using the Bayer ADVIA IMS assay method must be interpreted in conjunction with all other available clinical and laboratory data before a medical decision is determined.

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The provided text describes the acceptance criteria and the study for the Bayer ADVIA® IMS PSA assay.

Here's the information extracted and organized as requested:

Acceptance Criteria and Device Performance for Bayer ADVIA® IMS PSA Assay

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state pre-defined acceptance criteria in a table format, but rather reports performance characteristics. Based on the data presented and common analytical testing standards, the implicit acceptance criteria are inferred to be comparable or superior to the predicate device (Immuno 1 PSA Assay).

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

• Correlation Studies (Test Set):

  • N=54 serum samples (0.37-79.70 ng/mL)
  • N=44 serum samples (0.07-62.93 ng/mL)

• Imprecision Study: Six calibrator levels and commercial controls were tested. The exact number of individual samples (replicates for each level) is not specified but implied to be sufficient for robust CV calculation.

• Interfering Substances Study: Serum pool with PSA concentration of 4.0 ng/mL was spiked. Specific number of samples beyond "serum pool" is not detailed.

• Recovery Study: Four samples were used, each with several dilutions (5 dilution points per sample).

• Data Provenance: Not explicitly stated (e.g., country of origin, specific clinical sites). The study type is retrospective as it involves analyzing existing serum samples and comparing the new assay results to those obtained from a predicate device.

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

This type of in vitro diagnostic device (immunoassay) does not typically involve human expert interpretation for establishing ground truth in the same way as imaging or pathology studies. The "ground truth" for the test set is established by the measurements from the predicate device (Immuno 1 PSA Assay), which is itself a legally marketed and presumably validated diagnostic tool. Therefore:

• Number of experts: Not applicable in the context of interpretation.
• Qualifications of experts: Not applicable.

4. Adjudication method for the test set

Not applicable. The ground truth for comparative studies of quantitative assays is typically the result from the established predicate method, not a consensus of human interpretations.

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

Not applicable. This is an in vitro diagnostic assay, not an imaging or AI-assisted diagnostic tool that involves human readers interpreting cases.

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

Yes, the studies presented (Imprecision, Correlation, Interfering Substances, Recovery, Analytical Range, Minimum Detectable Concentration) are all standalone performance evaluations of the ADVIA IMS PSA assay system. There is no human intervention in the measurement process once the sample is loaded and the assay runs. The results are quantitative values generated directly by the device.

7. The type of ground truth used

The primary ground truth used for performance validation is:

• Predicate Device Measurements: For correlation studies, the results obtained from the Immuno 1 PSA Assay on the same samples serve as the comparison (reference) "ground truth" for the new ADVIA IMS assay.
• Known Concentrations/Spikes: For imprecision, recovery, and interfering substance studies, known concentrations of PSA or spiked substances are used as the "ground truth" against which the device's measurements are evaluated.

8. The sample size for the training set

This document does not describe a "training set" in the context of machine learning or AI models. For an immunoassay, the concept of a training set is not directly applicable. The assay is developed and optimized during its R&D phase, and the studies presented here are for validation.

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

Not applicable, as there is no mention of a training set for an AI model in this document. The "ground truth" for developing an immunoassay would be established through a combination of chemical principles, antibody specificity, detection methods, and extensive optimization using known calibrators and reference materials.

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This in vitro immunoassay is intended to quantitatively measure OC 125 reactive determinants associated with a high molecular weight glycoprotein in serum of women with primary epithelial invasive ovarian cancer using ADVIA IMS CA125 II Assay on a Bayer ADVIA® IMS™. CA 125 II Assay is indicated as an aid in the management (monitoring) of ovarian cancer patients when used in conjunction with other diagnostics procedures. The CA125 II Assay is also indicated as a one-time test for use as an aid in the detection of residual ovarian carcinoma in patients who have undergone firstline therapy and would be considered diagnostic second-look procedures. This assay is not intended for screening or diagnosis of ovarian cancer or for use on any other system.

The Bayer ADVIA® IMS™CA 125 II Assay is an in vitro diagnostic device intended to quantitatively measure OC 125 reactive determinants associated with a high molecular weight glycoprotein in serum of women with primary epithelial invasive ovarian cancer. The CA 125 II Assay is indicated as an aid in the management (monitoring) of ovarian cancer patients when used in conjunction with other diagnostic procedures. The CA 125 II Assay is also indicated as a one-time test for use as an aid in the detection of residual ovarian carcinoma in patients who have undergone first-line therapy and would be considered for diagnostic second-look procedures. An assay value of greater than 35 UlmL is predictive of residual disease, provided that alrernate causes of elevated CA 125 II Assay values can be excluded. It is recommended that the assessment and treatment of patients with ovarian cancer and the use of this CA 125 II Assay be under the order of a physician trained and experienced in the management of gynecologic cancers. This assay is not intended for screening or diagnosis of ovarian cancer or for use on any other system.

This in vitro immunoassay is intended to quantitatively measure OC 125 reactive determinants associated with a high molecular weight glycoprotein in serum of women with primary epithelial invasive ovarian cancer using ADVIA IMS CA125 II Assay on a Bayer ADVIA® IMS™.

The provided documents detail the performance evaluation of the Bayer ADVIA® IMS™ CA 125 II Assay, particularly by comparing it to a predicate device (Immuno 1 CA125 II Assay). This is a technical summary for a 510(k) submission, focusing on establishing substantial equivalence rather than a typical clinical study with acceptance criteria for a new AI device or a novel diagnostic. As such, some of the requested information, such as the number of experts used for ground truth, adjudication methods, or AI-specific details (MRMC, standalone algorithm performance, training set details), are not applicable or provided in this type of submission for an immunoassay.

Here's an interpretation of the available information against your request:

Acceptance Criteria and Device Performance for CA 125 II Assay

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission for an immunoassay, the "acceptance criteria" are implied by showing the device's performance is comparable to a legally marketed predicate device (Immuno 1 CA125 II Assay) and within acceptable limits for a clinical laboratory test. The document does not explicitly state "acceptance criteria" for each metric in a pass/fail format but rather presents the results of equivalence studies. We can infer the "acceptance criteria" were met because the 510(k) was cleared.

2. Sample Size and Data Provenance for Test Set

• Correlation Study (Serum): N = 45 (compared to Immuno 1). The document does not specify the country of origin. This appears to be retrospective, using existing samples for method comparison.
• Longitudinal Samples Evaluation: Two examples of serial patient monitoring studies are shown graphically. The table for sensitivity/specificity for clinical status changes has N=28 (total specimens, implies 28 instances of clinical change/no change being assessed). Data provenance (country, retrospective/prospective) is not specified.
• Interfering Substances: Low serum pools were spiked. The number of samples for each interference test is not explicitly given, but typically involves a few replicates for each substance. Data provenance is not specified.

3. Number of Experts and Qualifications for Ground Truth

• Not applicable for this immunoassay submission. For this type of device, "ground truth" is established by the reference measurement method (the predicate device, Immuno 1) or by the expected analytical performance characteristics for laboratory tests, rather than expert interpretation of images or clinical cases.
• The longitudinal evaluation references "guidelines by Bast et al," which suggests clinical experts defined what constitutes disease progression (doubling of CA125 II values) and response to therapy (50% decrease). However, no specific number or qualifications of experts involved in the study's ground truth assessment are provided.

4. Adjudication Method for the Test Set

• Not applicable for this immunoassay submission. Adjudication methods like 2+1 or 3+1 are typically used for subjective assessments (e.g., image-based diagnosis) where multiple readers provide initial interpretations. For an immunoassay, the result is a quantitative value, and comparisons are made against a reference method or clinical outcome definitions, not expert reconciliation of interpretations.

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

• No, not performed. An MRMC study is not relevant for an immunoassay that produces a quantitative numerical result. This type of study assesses human reader performance with and without an AI assistant, which is not applicable here.

6. Standalone (Algorithm Only) Performance Study

• Yes, in essence. The entire submission describes the standalone performance of the ADVIA® IMS™ CA 125 II Assay. It is an automated in vitro diagnostic device, and its performance characteristics (imprecision, linearity, correlation, etc.) are intrinsically "algorithm only" in the context of it being a laboratory instrument and assay, without a human-in-the-loop interacting with its fundamental measurement principle. The output is a quantitative value, not a diagnostic interpretation that would then be reviewed by a human.

7. Type of Ground Truth Used

• Reference Method/Predicate Device: For analytical performance (imprecision, linearity, parallelism, correlation), the Immuno 1 CA125 II Assay served as the primary reference for comparison, indicating "substantial equivalence" as the ground truth.
• Clinical Definitions: For longitudinal monitoring, "ground truth" for clinical status change (progression, response) was based on established guidelines (Bast et al.) related to CA125 II value changes correlating with disease progression or response to therapy.
• Spiking/Known Concentrations: For interfering substances and analytical range, ground truth was based on known concentrations of spiked substances or samples with pre-determined high/low CA125 levels.

8. Sample Size for the Training Set

• Not applicable. This is an immunoassay, not an AI/machine learning device that requires a "training set" in the conventional sense. The assay's chemical and mechanical parameters are developed through standard laboratory procedures and optimization, not machine learning model training.

9. How Ground Truth for the Training Set Was Established

• Not applicable. As above, there is no "training set" or "ground truth" for it in the context of an AI/ML algorithm. The assay's development involves optimizing reagent formulations, instrument settings, and calibration processes, which are guided by established analytical chemistry principles and empirical testing.

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