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For in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma using the ADVIA Centaur® System. This assay is indicated for the measurement of plasma BNP as an aid in the diagnosis and assessment of the severity of heart failure. In patients with acute coronary syndromes (ACS), this test, in conjunction with other known risk factors, can also be used to predict survival as well as to predict the likelihood of future heart failure. This assay is not intended for use on any other system.

For in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma using the ACS:180® Automated Chemiluminescence System. This assay is indicated for the measurement of plasma BNP as an aid in the diagnosis and assessment of the severity of heart failure. In patients with acute coronary syndromes (ACS), this test, in conjunction with other known risk factors, can also be used to predict the likelihood of future heart failure. This assay is not intended for use on any other system.

The ACS:180 and ADVIA Centaur BNP assays are fully automated two-site sandwich immunoassays using direct chemiluminescent technology. The first antibody, in the Reagent, is an acridinium ester labeled monoclonal mouse anti-human antibody specific to the N-terminal portion of BNP. The second antibody, in the Solid Phase Reagent, is a biotinylated monoclonal mouse anti-human antibody specific to the C-terminal portion of BNP, which is coupled to streptavidin coated magnetic particles. Patient sample (calibrators or control materials) is incubated for 5 minutes at 37°C with the Solid Phase Reagent and the tracer antibody conjugate. Subsequently, Solid Phase Reagent is added and incubated for 2.5 minutes at 37°C. An immuno-complex is formed between the unbound antibody conjugates are washed away. Following incubation, the immuno-complex signal is measured in a luminometer. The chemiluminescent signal will have a minimum amount of bound AE label, while Samples with high levels of BNP will have maximum label complex bound. Thus, a direct relationship exists between the amount of BNP present in the patient sample and the relative light units (RLUs) detected by the system.

Here's an analysis of the provided text regarding the Bayer Diagnostics ADVIA Centaur BNP Assay, broken down by your requested criteria:

The provided document is a Summary of Safety and Effectiveness for the Bayer Diagnostics ADVIA Centaur BNP Assay and ACS:180 BNP Assay, primarily focusing on its updated indications for use and substantial equivalence to previously cleared devices. It describes the technological and performance characteristics but does not contain detailed study results like typical acceptance criteria tables for accuracy or precision studies against a defined benchmark. Instead, it states that the characteristics (like precision, measuring range, analytical sensitivity, etc.) are "Same" as the predicate device.

Therefore, for aspects like "reported device performance" against acceptance criteria, "sample sizes used for the test set," "number of experts," "adjudication method," "MRMC study effect size," and "standalone performance," the provided document does not contain this information. It relies on the previously cleared predicate devices for establishing performance equivalency without re-presenting the detailed studies.

Here's what can be extracted based on the information available:

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

The provided document does not explicitly present a table of acceptance criteria with corresponding device performance from new studies following the format typically seen for a new device's primary validation. Instead, it compares the proposed device's characteristics to a predicate device, largely stating they are "Same."

However, we can infer some "performance characteristics" that are deemed acceptable by virtue of being equivalent to the predicate.

The study that "proves the device meets the acceptance criteria" is implicitly the previous 510(k) clearances for the predicate devices (K031038 and K040425). The current submission (K043228) relies on substantial equivalence to these predicate devices for its performance characteristics. The document explicitly states: "The Bayer B-type Natriuretic Peptide (BNP) assays on the ACS:180® and ADVIA Centaur® are substantially equivalent to ADVIA Centaur® BNP assay." And for the technological and performance tables, it consistently lists "Same" for the proposed device's characteristics when compared to the current (predicate) one.

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

• Sample size: Not specified in the provided document for the current submission's validation. The document states "Same" for all performance characteristics, implying reliance on the studies for the predicate devices (K031038 and K040425).
• Data provenance: Not specified in the provided document. As the submission relies on substantial equivalence to predicate devices, the original data provenance would be from those prior submissions.

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

This information is not provided in the document as it focuses on an in vitro diagnostic assay, not an imaging device requiring expert interpretation for ground truth.

4. Adjudication method for the test set

This information is not provided as it is not relevant to this type of IVD device submission.

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 provided. This type of study (MRMC for AI assistance) is not applicable to an in vitro diagnostic assay like a BNP test.

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

The device is an in vitro diagnostic assay. Its performance is inherently standalone in the sense that it measures BNP levels from a sample without human interpretive assistance for the measurement itself. The results are then used by clinicians. The performance characteristics described (precision, sensitivity, range, etc.) are its standalone performance.

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

For an in vitro diagnostic assay like BNP, the "ground truth" for accuracy and calibration would typically be established against:

• A reference standard system (e.g., highly pure synthetic human BNP (amino acid 77 to 108) as mentioned for traceability).
• Known concentrations of analytes (for linearity, sensitivity verification).
• Clinical correlation (for assessing diagnostic utility against patient outcomes or established clinical diagnoses, such as heart failure diagnosis confirmed by other clinical methods or follow-up).
  The document mentions "Reference standard - synthetic human BNP (amino acid 77 to 108) in buffer based matrix" for traceability.

8. The sample size for the training set

This information is not provided. Given that this is an immunoassay and the submission is for substantial equivalence, the concept of a "training set" in the context of machine learning/AI (which your question implies) is not applicable here. The assay development would involve extensive analytical validation, but not typically a machine learning "training set."

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

As above, the concept of a "training set" for AI is not applicable to this immunoassay. The ground truth for analytical validation (e.g., establishing accurate measurement, precision) is based on reference materials, calibrators, and controlled experimental conditions.

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For in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma using the ACS:180® Automated Chemiluminescence System. This assay is indicated for the measurement of plasma BNP as an aid in the diagnosis and assessment of the severity of heart failure. This test, in conjunction with other known risk factors, can also be used to predict survival in patients after myocardial infarction. This assay is not intended for use on any other system.

For in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma using the ADVIA Centaur® System. This assay is indicated for the measurement of plasma BNP as an aid in the diagnosis of and assessment of the severity of heart failure. This test, in conjunction with other known risk factors, can also be used to predict survival in patients after myocardial infarction. This assay is not intended for use on any other system.

The ACS:180 and ADVIA Centaur BNP assays are fully automated two-site sandwich immunoassays using direct chemiluminescent technology, which use constant amounts of two monoclonal antibodies. The first antibody, in the Lite Reagent, is an acridinium ester labeled monoclonal mouse anti-human BNP F(ab')2 fragment specific to the ring structure of BNP. The second antibody, in the Solid Phase, is a biotinylated monoclonal mouse antihuman antibody specific to the C-terminal portion of BNP, which is coupled to streptavidin magnetic particles. Patient sample (calibrator or control materials) is incubated for 5 minutes at 37°C with the Reagent that contains the tracer antibody conjugate. Subsequently, Solid Phase reagent is added and incubated for 2.5 minutes at 37°C. An immuno-complex is formed between the BNP in the sample and the two antibody conjugates. Following incubation, the unbound antibody conjugates are washed away. The chemiluminescence of the immuno-complex signal is measured in a fuminometer. Samples with low BNP levels will have a minimum amount of bound AE label, while samples with high levels of BNP will have maximum label complex bound. Thus, a direct relationship exists between the amount of BNP present in the patient sample and the amount of relative light units (RLUs) detected by the system.

The provided text describes a 510(k) premarket notification for the ACS:180® and ADVIA Centaur® BNP Assays by Bayer Diagnostics. The document establishes substantial equivalence to a predicate device (ADVIA Centaur® B-Type Natriuretic Peptide (BNP) Assay, K031038) and discusses the assays' technological and performance characteristics.

Here's an analysis of the acceptance criteria and study information provided, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" for performance metrics in a pass/fail format. However, it presents the "Performance Characteristics" of the proposed devices, which implicitly serve as the demonstrated performance that FDA found substantially equivalent to the predicate device. These performance characteristics cover various analytical aspects of the assay. Since the document states "The following table compares the performance characteristics of the current and proposed Bayer ADVIA Centaur and ACS:180 BNP assays," and the values listed under "Proposed Bayer ADVIA Centaur® and ACS:180® BNP Immunoassays" are identical to "Current Bayer ADVIA Centaur® and ACS:180® BNP Immunoassays," it implies that the new devices meet the established performance of the predicate device.

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

The document does not specify the exact sample sizes for the test sets or the data provenance (country of origin, retrospective/prospective) for each stated performance characteristic. It only presents the summary results. For clinical diagnostic assays like this, it's common for studies to involve various patient samples to assess precision, analytical sensitivity, dilution recovery, and interference. However, these details are not provided in this summary.

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

This document describes an in vitro diagnostic (IVD) assay which measures a biomarker (BNP). The "ground truth" for such assays is typically the actual concentration of the analyte, established through highly accurate and precise analytical methods, not through expert human review in the same way an imaging AI would be reviewed. Therefore, the concept of "experts" establishing ground truth for evaluating the device's analytical performance (precision, sensitivity, etc.) is not directly applicable in this context. The "ground truth" here is determined by the reference analytical methods themselves.

4. Adjudication Method for the Test Set

As explained above, for analytical performance characteristics of an IVD assay, there isn't a direct "adjudication method" in the sense of reconciling disagreements among human experts evaluating data. The performance is assessed against established analytical standards and reference methods.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for medical devices that involve human interpretation (e.g., radiologists reading images and an AI assisting them). The ACS:180 and ADVIA Centaur BNP assays are entirely automated quantitative tests, so human interpretation of the assay's direct output (BNP concentration) is not the primary focus of performance evaluation in the same way. The device's output itself is a numerical value.

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

Yes, the performance characteristics presented are for the standalone algorithm/device (the automated immunoassay system). The device provides a quantitative measurement of BNP without human intervention in the measurement process itself. The "without human-in-the-loop" aspect is inherent to automated diagnostic assays.

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

The ground truth for evaluating the analytical performance of these BNP assays is based on:

• Reference Standards/Synthetic Materials: Used for calibration and establishing traceability (e.g., "synthetic human BNP (amino acid 77 to 108) in buffer-based matrix").
• Known Concentrations: Samples with precisely known BNP concentrations are used to assess accuracy, linearity, and recovery.
• Validated Analytical Methods: Comparison against established and validated laboratory methods or reference methods to verify analytical parameters like precision, sensitivity, and linearity.
• Controlled Interference Studies: Samples spiked with known interfering substances at controlled concentrations to determine the device's robustness to these interferences.

For the stated clinical indications for use (diagnosis and assessment of heart failure severity, prediction of survival after MI), the clinical utility of BNP levels is established through extensive medical literature and clinical studies that correlate BNP levels with patient outcomes, pathology (e.g., echocardiography, cardiac catheterization), and clinical diagnoses. The device's role is to accurately measure these established BNP levels. The document mentions "Decision threshold of 100 pg/mL recommended for diagnosis of heart failure. Decision threshold of 80 pg/mL recommended for prediction of survival after myocardial infarction," which are clinical ground truths, but not data used to directly evaluate the analytical performance of the device in this submission.

8. The Sample Size for the Training Set

The document does not provide details on specific "training sets" in the context of an algorithm that learns from data. This type of immunoassay is based on established biochemical principles and reagents, not a machine learning model that requires a distinct training phase with a dataset. The development and optimization of the assay would involve extensive R&D and testing with numerous samples, but these are not typically referred to as a "training set" in the sense of AI/ML.

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

As this is an immunoassay and not an AI/ML device, the concept of a "training set" with associated ground truth for learning is not directly applicable. The "ground truth" for the development and validation of such an assay would be based on:

• Precise gravimetric/volumetric measurements for reagent preparation.
• Characterization of antibodies and their binding kinetics.
• Use of highly purified and characterized synthetic BNP standards.
• Comparative analysis with established reference methods during the assay development process to ensure analytical accuracy and reliability.

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For the quantitative determination of alpha-fetoprotein (AFP) in the following: human serum, as an aid in managing non-seminomatous testicular cancer when used in conjunction with physical examination, histology/pathology, and other clinical evaluation procedures, using the Bayer Diagnostics ACS:180 Automated Chemiluminescence System or the ADVIA Centaur System.

The Bayer Diagnostics ACS:180 & ADVIA Centaur AFP immunoassay is a two-site immunoassay using direct chemiluminometric technology, which uses constant amounts of two antibodies. The first antibody, in the Lite Reagent, is a purified polyclonal rabbit anti-AFP antibody labeled with acridinium ester. The second antibody, in the Solid Phase, is a monoclonal mouse anti-AFP antibody covalently coupled to paramagnetic particles. A direct relationship exists between the amount of AFP present in the patient sample and the amount of relative light units (RLU's) detected by the system.

The provided text describes the performance data for the ACS:180 & ADVIA Centaur AFP Immunoassay. Here's an analysis based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Note on Acceptance Criteria: The document does not explicitly state specific numerical acceptance criteria for correlation coefficients or minimum detectable limits. Instead, it presents the performance data in comparison to a predicate device (ACS:180 for ADVIA Centaur) and other established methods. The "acceptance criteria" are implied by the excellent correlation values (r=0.99 for ADVIA Centaur vs. ACS:180) which are typically considered a strong indicator of agreement in such assays.

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

• ADVIA Centaur Accuracy Test Set: 498 serum samples.
• ACS:180 Accuracy Test Set (vs. alternate methods):
  • vs. Abbott IMX: 504 samples
  • vs. Kallestd AFP/Ob (first test): 1575 samples
  • vs. Abbott mEIA: 183 samples
  • vs. Kallestd AFP/Ob (second test): 477 samples
• Data Provenance: Not explicitly stated. The document describes clinical performance data but 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

• This information is not provided in the document. The study compares the device's measurements to existing established methods (predicate device and alternate AFP methods), not to a ground truth established by human experts in the traditional sense of image or pathology review.

4. Adjudication Method for the Test Set

• Not applicable. The "ground truth" for these tests are the results from the established existing immunoassay methods. There is no mention of human adjudication as would be relevant for subjective assessments.

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

• No. This type of study is typically done for diagnostic imaging devices where human interpretation is a key component. The ACS:180 & ADVIA Centaur AFP Immunoassay is an in vitro diagnostic (IVD) immunoassay that provides quantitative results. Therefore, an MRMC study is not relevant for this device.

6. Standalone Performance Study

• Yes, standalone performance was assessed. The "Performance Data" section details the sensitivity (minimum detectable concentration) and accuracy (correlation with predicate and other immunoassay methods) of the devices themselves, without direct human intervention in the result generation. The device outputs a quantitative value for AFP concentration based on its internal processes.

7. Type of Ground Truth Used

• The "ground truth" in this context is the results obtained from legally marketed and established predicate/alternate AFP immunoassay methods. The study aims to demonstrate that the new devices produce results that are highly correlated and comparable to these existing, accepted methods.

8. Sample Size for the Training Set

• This information is not provided in the document. Immunoassays typically involve calibration and validation rather than a "training set" in the machine learning sense. The document describes performance data, likely from validation studies, rather than development or training phases.

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

• Not applicable / Information not provided. As mentioned above, the concept of a "training set" and "ground truth" for it, as typically used in machine learning, does not align with the description of this immunoassay. The document focuses on demonstrating performance against established methods.

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The ACS:180 and ADVIA Centaur Intact PTH Immunoassay is intended for the quantitative determination of intact parathyroid hormone in human EDTA plasma on the automated ACS:180 and ADVIA Centaur analyzers marketed by Bayer Corporation. Intact PTH levels can be used to aide in the differential diagnosis of hyperparathyroidism, hypoparathyroidism, or hypercalcemia of malignancy.

The ACS:180 Intact PTH assay is a two-site "sandwich" immunoassay using direct, chemiluminometric technology, which uses two affinity purified goat polyclonal antibodies specific for the PTH molecules. The first antibody is directed toward the N-terminal (1-34) antigenic PTH domain and is labeled with acridinium ester (AE). The second antibody is directed toward the C-terminal (39-84) antigenic domain and is labeled with biotin. Patient sample (calibrator or control material) is incubated, for 5 minutes at 37°C with the Lite Reagent (LR) material that contains both the capture and tracer antibody conjugates. An immuno-complex is formed between the intact PTH in the sample and the two antibody conjugates. Subsequently, Solid Phase (SP) reagent is added and incubated for 2.5 minutes at 37°C. The immuno-complex molecule is captured by the streptavidim coated paramagnetic particles in the SP. Following incubation the unbound antibody conjugates are washed away. The chemiluminescent of the immuno-complex signal is measured in a luminometer. A sample with low intact PTH will have a minimum amount of bound AE label, while samples containing high levels of intact PTH will have maximum label complex bound. Thus, a direct relationship exists between the amount of intact PTH present in the sample and the amount of relative light units (RLUs) detected by the system.

The provided text describes the Bayer Diagnostics ACS:180 and ADVIA Centaur Intact PTH Immunoassay, focusing on its comparison to a predicate device to establish substantial equivalence for FDA clearance.

Here's the breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the FDA's "substantial equivalence" determination, which typically relies on demonstrating comparable performance to an already cleared predicate device. The performance metrics reported are primarily correlation and agreement with the predicate device.

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

• ACS:180 vs. Predicate Device:
  • Sample Size: 100 EDTA plasma samples.
  • Data Provenance: Not explicitly stated (e.g., country of origin, specific population). The study is described as a "method comparison" which implies a prospective collection for this testing, but it's not explicitly stated as retrospective or prospective.
• ADVIA Centaur vs. ACS:180:
  • Sample Size: This comparison used transference for 268 EDTA plasma samples, with results reported for 252 samples.
  • Data Provenance: Not explicitly stated (e.g., country of origin, specific population). The use of "transference" implies a process of validating reference intervals from one system to another, likely using a new set of samples, but doesn't explicitly state retrospective or prospective.

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

This document describes an immunoassay device, which measures a specific analyte concentration (Intact PTH) in a sample. The "ground truth" for such devices is typically the result obtained from a gold- standard or predicate assay. Therefore, there are no "experts" in the sense of human readers interpreting images, but rather the established accuracy of the predicate device's measurements.

4. Adjudication Method for the Test Set

Not applicable. This is an immunoassay device, not one requiring human adjudication of results. The comparison is quantitative between two analytical methods.

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 immunoassay device, not an imaging or diagnostic device that involves human readers interpreting cases, with or without AI assistance.

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

Yes, the studies described are standalone performance studies of the ACS:180 and ADVIA Centaur Intact PTH immunoassays. They function as automated laboratory tests without human interpretation affecting the quantitative result. The comparison is between the new device and a predicate device (also an automated or manual assay).

7. The Type of Ground Truth Used

The ground truth for the device's performance was established using the measurements from the predicate device, the Nichols Institute Diagnostics Intact Parathyroid Hormone (PTH) kit (K954418). The assumption is that the predicate device's results are sufficiently accurate and are the benchmark for "truth" in this context.

8. The Sample Size for the Training Set

The document does not explicitly state a "training set" size. For laboratory assays, "training" often refers to the development phase (e.g., reagent formulation, assay parameters) and initial validation studies, rather than a distinct, labeled dataset for algorithm training as seen in AI/ML products. The reported data pertains to the validation of the final product.

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

Since a "training set" in the context of an AI/ML device is not explicitly described, the method for establishing its ground truth is not detailed. For the validation studies, as mentioned in point 7, the predicate device results served as the ground truth. The development of an immunoassay itself involves extensive research, optimization, and calibration using characterized samples and reference materials, but these are not typically described as "training set" and "ground truth establishment" in the same way as for AI.

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The Chiron Diagnostics ACS:180 BR is an in vitro diagnostic test for the quantitative serial determination of cancer antigen CA 27.29 in human serum using the Chiron Diagnostics ACS:180® Automated Chemiluminescence Systems. The test is intended for use as an aid in monitoring patients previously treated for Stage II or Stage III breast cancer. Serial testing for CA 27.29 in the serum of patients who are clinically free of disease should be used in conjunction with other clinical methods used for the early detection of cancer recurrence. The test is also intended for use as an aid in the management of breast cancer patients with metastatic disease by monitoring the progression or regression of disease in response to treatment.

The Chiron Diagnostics ACS:180 BR assay is a fully automated, competitive, chemiluminescent assay. One reagent, designated Lite Reagent, is composed of a mouse monoclonal antibody specific for CA 27.29, labeled with acridinium ester. The antibody used in the assay, MAb B27.29, binds to a peptide epitope in the tandem repeat region of the MUC-1 gene product. The Solid Phase is composed of purified breast cancer antigen (CA 27.29) which is covalently coupled to paramagnetic particles (PMP). After onboard pretreatment, the patient serum sample is incubated with both reagents simultaneously for 7.5 minutes.

The ACS: 180 system automatically performs the following steps:

• dispenses sample and Pretreatment Reagent into a cuvette .
• dispenses Lite Reagent and Solid Phase and incubates for 7.5 minutes u
• separates, aspirates and washes the cuvettes
• dispenses reagents which initiate the chemiluminescent reaction
• = reports results

An inverse relationship exists between the concentration of CA27.29 in a sample and the relative light units (RLU) detected by the system.

The provided text describes a 510(k) premarket notification for a modified in vitro diagnostic device, the ACS:180 BR, which is an automated chemiluminescence system for detecting cancer antigen CA 27.29 in human serum.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" but rather focuses on demonstrating "substantial equivalence" to a predicate device. The primary performance metric reported is the correlation between the modified assay and the predicate device.

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

• Sample Size: Over 875 specimens.
• Data Provenance: The document does not specify the country of origin. It does not explicitly state whether the data was retrospective or prospective, but it implies a retrospective comparison of previously collected specimens, given the statement "These specimens had CA 27.29 levels that spanned the range from 3.68 U/mL to 420 U/mL."

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

The study described is a method comparison study between a modified device and a predicate device, not typically requiring expert-established "ground truth" in the same way an imaging or diagnostic AI device would. The "ground truth" here is the measurement provided by the existing, legally marketed predicate device. Therefore, no information is provided regarding expert qualifications or the number of experts used to establish ground truth in this context.

4. Adjudication Method for the Test Set

Not applicable. This was a direct comparison of measurements between two diagnostic assays, not a study requiring adjudication of interpretations.

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

No, an MRMC comparative effectiveness study was not done. This is a comparison between two automated diagnostic assays, not a study involving human readers or AI assistance for interpretation.

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

Yes, this was a standalone performance comparison study of the device (an automated chemiluminescence system) against its predicate device. The results reported are for the device (modified assay) performing on its own, without human intervention in the measurement process beyond standard laboratory procedures.

7. The Type of Ground Truth Used

The "ground truth" for this comparative study was the results obtained from the predicate device (the original ACS:180 BR assay). The objective was to show that the modified assay yielded results substantially equivalent to the established predicate.

8. The Sample Size for the Training Set

The document does not mention a "training set" in the context of machine learning or AI. This is a traditional in vitro diagnostic device modification, where performance is typically validated through comparison to a well-established method, not through machine learning training and testing paradigms. Therefore, information on a training set size is not applicable/provided.

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

Not applicable, as no training set (in the machine learning sense) is described or implied for this type of device validation.

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Chiron Diagnostics ACS:180 BR is an in vitro diagnostic test for the quantitative serial determination of cancer antigen CA 27.29 in human serum. The test is intended for use as an aid in the management of breast cancer patients with metastatic disease by monitoring the progression or regression of disease in response to treatment.

The Chiron Diagnostics ACS:180 BR assay is a competitive, chemiluminescent assay intended for use on the Chiron Diagnostics Automated Chemiluminescent System (ACS). One reagent, designated Lite Reagent, is composed of a mouse monoclonal antibody specific for CA 27.29, labeled with acridinium ester. The Solid Phase is composed of purified breast cancer antigen covalently coupled to paramagnetic particles (PMP). The patient serum sample is incubated with both reagents simultaneously for 7.5 minutes. An inverse relationship exists between the concentration of CA 27.29 in a sample and the relative light units (RLU) detected by the ACS:180 system. Automatic dilution is available on the ACS:180® for the ACS:180 BR assay.

Here's a breakdown of the acceptance criteria and study information for the Chiron Diagnostics ACS:180 BR device, based on the provided text:

Acceptance Criteria and Reported Device Performance

Study Information

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

• Test Set for Clinical Trial Results: The exact sample size for the "Clinical Trial Results" (Sensitivity, Specificity, PPV, NPV) is not explicitly stated, but it is described as a "Prospective Clinical Trial." The country of origin is not mentioned.
• Test Set for Normal Range/ULN: 314 healthy volunteer donors were tested at three laboratories. Data provenance is not specified.
• Test Set for Specificity (Non-breast Malignancies):
  • Colon: 43
  • Liver: 20
  • Lung: 47
  • Ovary: 50
  • Pancreas: 45
  • Prostate: 34
  • Stomach: 29
  • Uterus: 30
    Data provenance is not specified.
• Test Set for Specificity (Other Diseases/Conditions):
  • Benign Breast Disease (Breast Adenoma): 61
  • Benign Breast Disease (Fibrocystic Breasts): 68
  • Cirrhosis: 25
  • Endometriosis: 24
  • Lactating Woman: 37
  • Mild Chronic Hepatitis: 28
  • Ovarian Cyst: 50
  • Pregnancy: 49
  • Renal Impairment: 20
  • Severe Chronic Hepatitis: 20
    Data provenance is not specified.
• Test Set for Potentially Interfering Substances: Five serum pools containing CA 27.29 at different levels.
• Test Set for Correlation with Predicate Device: 203 specimens overall, including a subset of 103 women with histologically confirmed breast cancer. Data provenance is not specified.

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

• The document does not specify the number or qualifications of experts used to establish ground truth for any of the clinical or specificity studies. For the breast cancer patients used in the correlation study, it mentions "histologically confirmed breast cancer," implying pathology involvement, but details are absent.

4. Adjudication method for the test set:

• The document does not mention any adjudication method for establishing ground truth for the test sets.

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 device is an in vitro diagnostic test (an automated chemiluminescence system) for measuring a cancer antigen in human serum. This type of device does not involve "human readers" or "AI assistance" in the typical sense of imaging or diagnostic interpretation. Therefore, an MRMC comparative effectiveness study in the context of human readers improving with AI would not be applicable and was not performed.

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

• Yes, the entire study focuses on the standalone performance of the ACS:180 BR automated system. It is designed to perform the quantitative determination of CA 27.29 without human intervention in the assay process itself, beyond sample loading and results interpretation by a clinician.

7. The type of ground truth used:

• Clinical Trial Results (Sensitivity/Specificity to Change in Disease Status): Implied to be clinical disease progression or regression based on established clinical practice, though the exact method (e.g., imaging, clinical assessments, pathology) is not detailed.
• Specificity Studies (Non-breast Malignancies, Other Diseases/Conditions): Based on the diagnosis of the malignancy or condition (e.g., "Colon," "Liver," "Benign Breast Disease").
• Normal Range/ULN: Based on results from healthy volunteer donors.
• Correlation with Predicate Device: The ground truth for the concentration of CA 27.29 was presumably the measurement from the predicate device (Biomira TRUQUANT® BR™ RIA), against which the new device was compared. For the breast cancer patient subset, the "histologically confirmed breast cancer" provides an additional clinical ground truth for the patient population itself.
• Interfering Substances/Antigens: Based on known concentrations of spiked substances and antigens in serum pools with established CA 27.29 levels.

8. The sample size for the training set:

• The document does not explicitly mention a separate "training set" or its sample size. This is a common characteristic of in vitro diagnostics developed and evaluated prior to the widespread use of deep learning AI, where training might involve assay optimization rather than large-scale data-driven model training.

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

• As a training set is not explicitly mentioned, the method for establishing its ground truth is also not described. The performance characteristics discussed relate to the validation or test of the final assay.

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