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The Diazyme Apolipoprotein A-I Assay is intended for the in vitro quantitative determination of apolipoprotein A-I (apo A-I) in serum. It can be used as an aid for assessing the risk of coronary artery disease. For in vitro Diagnostic use.

Calibrator: For calibration of the Diazyme Apolipoprotein A-I Assay in serum. For in vitro Diagnostic Use.

Controls: To monitor the performance of Diazyme Apolipoprotein A-I Assay in serum. For in vitro Diagnostic Use.

This method is based on the reaction of a sample containing human Apo A-I and specific antiserum to form an insoluble complex which can be measured turbidimetrically at 340nm. By constructing a standard curve from the absorbance of standards the concentration of Apo A-1 can be determined.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Diazyme Apolipoprotein A-I Assay:

It's important to note that this document is a 510(k) summary for a diagnostic assay, not a device with AI/ML components. Therefore, many of the requested fields related to AI/ML specific studies (MRMC, standalone algorithm performance, training/test set sample size for AI, ground truth establishment for AI) are not applicable and will be marked as such. The "acceptance criteria" here refer to performance specifications demonstrating substantial equivalence to a predicate device.

Acceptance Criteria and Device Performance

Study Proving Acceptance Criteria:

The Diazyme Apolipoprotein A-I Assay demonstrated substantial equivalence to the K-Assay Apo AI Assay by providing performance data within acceptable ranges or showing improvement compared to the predicate device's reported specifications.

Additional Information:

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

   • Sample Size: Not explicitly stated in the provided 510(k) summary for each performance metric. For diagnostic assays, this information is typically found in the full submission.
   • Data Provenance: Not specified, but generally, such studies for in-vitro diagnostics use human serum samples. The country of origin and whether it's retrospective or prospective is not mentioned.

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

   • Not Applicable. For this type of in-vitro diagnostic assay, "ground truth" is typically established by reference methods or validated comparative assays, not by expert consensus in the way it applies to image analysis or clinical diagnosis. The "ground truth" here is the actual concentration of Apo A-I in the samples, as determined by a reference method or the predicate device that itself has established accuracy.

3. Adjudication method for the test set:

   • Not Applicable. Adjudication typically refers to resolving discrepancies among multiple human readers, which is not relevant for an automated chemical assay.

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:

   • No. This is an in-vitro diagnostic assay, not an AI-assisted diagnostic tool.

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

   • Yes, by its nature. The performance data presented (reportable range, precision, accuracy) reflects the standalone performance of the Diazyme Apolipoprotein A-I Assay system as an automated chemical assay. There is no human-in-the-loop component relevant to the assay's core function of measuring Apo A-I concentration; humans load samples and interpret results, but the measurement itself is automated.

6. The type of ground truth used:

   • Comparative method/Reference Standard. The "ground truth" for calibrator value traceability is stated as the "WHO International Reference Material for Apo AI, Sp1-01." For assay accuracy, it's typically established by comparing results against a predicate device (K-Assay Apo AI Assay in this case) or another established reference method, where the predicate itself serves as a highly accurate measure for comparison, or against samples with known concentrations derived from a reference method.

7. The sample size for the training set:

   • Not Applicable. This is not an AI/ML device that requires a training set in the conventional sense. The "training" for a chemical assay involves optimizing reagents and protocols.

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

   • Not Applicable. See point 7.

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The Diazyme Apolipoprotein B Assay is intended for the quantitative determination of apolipoprotein B (apo B) in serum. It can be used as an aid for assessing the risk of coronary artery disease. For in vitro Diagnostic use.

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The Diazyme Apolipoprotein B Assay is a device intended for the quantitative determination of apolipoprotein B (apo B) in serum, to be used as an aid for assessing the risk of coronary artery disease.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state "acceptance criteria" in a quantitative sense with specific thresholds. However, it presents "Performance" data for the Diazyme Apolipoprotein B Assay and compares it to a predicate device (K-Assay Apo B Assay) to demonstrate substantial equivalence. The implication is that the performance of the Diazyme assay should be comparable or better than the predicate for regulatory acceptance.

Implicit Acceptance Criteria (inferred from predicate comparison): The Diazyme Apolipoprotein B Assay should demonstrate comparable or improved performance relative to the legally marketed K-Assay Apo B Assay, particularly in terms of reportable range, precision (within-run and total), and accuracy (correlation coefficient and slope/intercept).

The study demonstrates that the Diazyme Apolipoprotein B Assay's performance is comparable to, and in several key areas (precision within-run, correlation coefficient, and slope/intercept for accuracy), better than the predicate device. This supports the claim of substantial equivalence.

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

The document does not explicitly state the sample size used for the test set or the data provenance (country of origin, retrospective/prospective). The performance data is presented as summary statistics (ranges for precision, correlation coefficient, slope/intercept).

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

This information is not provided in the document. For in vitro diagnostic devices like the Diazyme Apolipoprotein B Assay, "ground truth" typically refers to reference methods and established standards. The document mentions that the calibrator value is "traceable to the WHO/IFCC Reference Standard" and "WHO International Reference Material for Apo B, SP3-07," which are the established reference points for accuracy. There's no mention of human experts establishing ground truth for individual samples.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1, 3+1, none) are typically relevant for studies involving human interpretation of images or clinical assessments where discrepancies between readers might occur. For an automated in vitro diagnostic assay, this concept does not directly apply. The "ground truth" is based on reference methods and established standards for the analyte measurement, not expert consensus on individual case interpretation.

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

An MRMC study is not applicable nor indicated for this type of in vitro diagnostic device. MRMC studies evaluate the performance of human readers, sometimes with and without AI assistance, especially in radiology or pathology. This device is an automated biochemical assay.

6. Standalone Performance Study

Yes, a standalone performance assessment was done. The "Performance" section explicitly lists metrics for the Diazyme Apolipoprotein B Assay such as:

• Reportable Range: 25.0 – 160 mg/dL
• Precision (Within Run): 1.2% -1.4%
• Precision (Total): 2.1%–4.8%
• Accuracy (Correlation Coefficient): 0.9864
• Accuracy (Slope/Intercept): $y = 1.0143x - 4.3806$ mg/dL

These figures represent the performance of the algorithm/assay itself, without human intervention in the measurement process. The comparison to the predicate device further contextualizes this standalone performance for regulatory purposes.

7. Type of Ground Truth Used

The ground truth for the device's performance is based on:

• Reference Standards: The calibrator values are traceable to "WHO/IFCC Reference Standard" and "WHO International Reference Material for Apo B, SP3-07." These are internationally recognized reference materials that establish the true concentration of Apolipoprotein B.
• Comparative Measurements: Accuracy is shown through correlation and regression against a legally marketed predicate device (K-Assay Apo B Assay), implying that the predicate's measurements serve as a comparative standard.

8. Sample Size for the Training Set

This information is not provided in the document. For an immunoturbidimetric assay, "training set" doesn't have the same meaning as in machine learning algorithms. The development process would involve calibration and optimization using characterized materials, but not a "training set" in the common AI sense.

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

As noted above, the concept of a "training set" with established ground truth is generally not applicable in the same way for an immunoturbidimetric assay as it would be for AI/ML devices. The "ground truth" for the development and calibration of such an assay would be established using certified reference materials and calibrators with known, traceable concentrations of Apolipoprotein B, as mentioned for the calibrator's traceability to WHO/IFCC standards.

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These products are to be used for the quantitative determination of apolipoprotein A1 and apolipoprotein B in human serum by immunoturbidimetric analysis. The determination of apolipoprotein A1 and apolipoprotein B are commonly performed as an aid in the assessment of individuals who are at risk for developing coronary artery disease.

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The provided text is a clearance letter from the FDA for an in vitro diagnostic device, specifically for Apolipoprotein A1 and Apolipoprotein B reagents and calibrators. This document is a regulatory approval and does not contain the information requested regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert qualifications for a device performance study.

The letter states that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory compliance requirements. It does not include data from a specific performance study.

Therefore, I cannot fulfill your request using the provided text. To answer your questions, I would need a document detailing the actual performance study conducted for the device's clearance.

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Dimension Vista" APOAI Flex® reagent cartridge: The APOAI method is an in vitro diagnostic test for the quantitative determination of apolipoprotein A-1 in human serum, heparinized plasma or EDTA plasma on the Dimension Vista® System. Measurements of apolipoprotein A-I aid in the diagnosis and treatment of lipid disorders, various liver and renal diseases and in the assessment of risk for atherosclerosis and cardiovascular disease.

Dimension Vista™ APOB Flex® reagent cartridge: The APOB method is an in vitro diagnostic test for the quantitative determination of apolipoprotein B in human serum, heparinized plasma or EDTA plasma on the Dimension Vista® System. Measurements of apolipoprotien B aid in the diagnosis and treatment of lipid disorders, various liver and renal diseases and in the assessment of risk for atherosclerosis and cardiovascular disease.

Dimension Vista" Apolipoprotein Calibrator: The APO CAL is an in vitro diagnostic product for the calibration of the apolipoprotein A-I (APOAI) and apolipoprotein B (APOB) methods on the Dimension Vista® System.

Dimension Vista™ Apolipoprotein Control: APO CON is an assayed intralaboratory quality control for assessment of precision and analytical bias in determination of apolipoprotein A-I (APOAI) and apolipoprotein B (APOB) on the Dimension Vista® System.

Dimension Vista™ APOAI and APOB Flex® reagent cartridges: Proteins contained in human body fluids form immune complexes in an immunochemical reaction with specific antibodies. These complexes scatter a beam of light passed through the sample. The intensity of the scattered light is proportional to the concentration of the respective protein in the sample. The result is evaluated by comparison with a standard of known concentration.

Dimension Vista" Apolipoprotein Calibrator: APO CAL is a multi-analyte, lyophilized, human serum based product containing apolipoprotein A-I and apolipoprotein B.

Dimension Vista™ Apolipoprotein Control: APO CON is a multi-analyte, lyophilized, human serum based product containing apolipoprotein A-I and apolipoprotein B.

The provided 510(k) summary describes the acceptance criteria and a study demonstrating the performance of the Dimension Vista™ APOAI and APOB Flex® reagent cartridges.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Dimension Vista™ APOAI and APOB assays are implicitly defined by their comparison to legally marketed predicate devices, specifically the Dade Behring N Antisera to Human Apo A-1 and Apo B assays on the BN ProSpec® System. The study aims to demonstrate "correlation and equivalent performance," and the reported objective metrics are high correlation coefficients (close to 1), slopes close to 1, and intercepts close to 0.

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

• Sample Size for Test Set:
  • For APOAI: 72
  • For APOB: 77
• Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given the context of a 510(k) summary for a submission to the US FDA from a German manufacturer, it's likely the samples were collected and analyzed to support the submission, but specific details are not provided. The samples tested were human serum.

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

This information is not applicable to this type of device and study. The ground truth for this diagnostic device is established by the results produced by a legally marketed predicate device (the Dade Behring N Antisera assays on the BN ProSpec® System), not by human expert interpretation. The study is a method comparison study comparing a new device to an existing one.

4. Adjudication Method for the Test Set

This information is not applicable as the ground truth is established by a predicate device, not by expert consensus requiring adjudication.

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. This is a laboratory diagnostic device (an in vitro diagnostic test for apolipoproteins), not an AI-powered image analysis or clinical decision support tool involving human readers/interpreters. Therefore, MRMC studies and AI assistance effect sizes are irrelevant to this submission.

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

Yes, a standalone performance study was done. The study directly compares the performance of the new device (Dimension Vista™ APOAI and APOB assays) against the predicate device, operating independently. There is no human intervention mentioned as part of the primary measurement process for the device itself during the comparison.

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

The ground truth for this method comparison study is the results obtained from the legally marketed predicate device: Dade Behring N Antisera to Human Apo A-1 and Apo B assays on the BN ProSpec® System. This is considered a "reference method" comparison in the context of IVD submissions, rather than a true "ground truth" derived from an absolute standard like pathology or long-term outcomes data, which would be typical for validating clinical efficacy.

8. The Sample Size for the Training Set

The document does not provide information regarding a "training set" or its sample size. This is typical for in vitro diagnostic device submissions like this. The assays are based on established immunochemical principles, and the development process would involve internal optimization and validation, but not a "training set" in the machine learning sense to establish the core algorithm. The data presented is for validation testing.

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

Since no training set is described or relevant in the context of this 510(k) submission for an IVD reagent cartridge, the method for establishing its ground truth is not applicable and not provided.

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The Bayer ADVIA 1650 Apolipoprotein A-1 (APO-A) assay is an in vitro diagnostic method intended to measure Apolipoprotein A-1 concentration in human serum and plasma on an Advia 1650 Chemistry System. Measurements are used to aid in the assessment of risk for arteriosclerosis and coronary artery disease.

The Bayer ADVIA 1650 Apolipoprotein B (APO-B) assay is an in vitro diagnostic method intended to measure Apolipoprotein B concentration in human serum and plasma on an Advia 1650 Chemistry System. Measurements are used to aid in the assessment of risk for arteriosclerosis and coronary artery disease.

The Bayer ADVIA 1650 Carbon Dioxide (CO2) assay is an in vitro fliagnostic method intended to measure Carbon Dioxide concentration in human serum and plasma on an Advia 1650 Chemistry System. Measurements obtained using this method assist in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.

The Bayer ADVIA 1650 C-Reactive Protein (CRP) assay is an in vitro diagnostic method intended to measure C-Reactive Protein concentration in human serum and plasma on an Advia 1650 Chemistry System. Measurements are used to aid in the evaluation of the amount of injury to body tissues. This test is useful in following the progress of rheumatic fever, rheumatoid arthritis, myocardial infarction, and malignancies.

The Bayer ADVIA 1650 Immunoglobulin A (IGA) assay is an in vitro diagnostic method intended to measure Immunoglobulin A (IGA) concentration in human serum and plasma on an Advia 1650 Chemistry System. Measurements are used to aid in the diagnosis of abnormal protein metabolism and the body's inability to resist infectious agents.

The Bayer ADVIA 1650 Immunoglobulin G (IGG) assay is an in vitro diagnostic method intended to measure Immunoglobulin G (IGG) concentration in human serum and plasma on an Advia 1650 Chemistry System. Measurements are used to aid in the diagnosis of abnormal protein metabolism and the body's inability to resist infectious agents.

The Bayer ADVIA 1650 Immunoglobulin M (IGM) assay is an in vitro diagnostic method intended to measure Immunoglobulin M (IGM) concentration in human serum and plasma on an Advia 1650 Chemistry System. Measurements are used to aid in the diagnosis of abnormal protein metabolism and the body's inability to resist infectious agents.

The Bayer ADVIA 1650 Transferrin (TFR) assay is an in vitro diagnostic device intended to measure Transferrin concentration in human serum and plasma on an Advia 1650 Chemistry System. Such measurements are used to aid in the diagnosis of malnutrition, chronic infection, acute hepatitis, polycythemia, pernicious anemia, and red blood cell disorders, such as iron deficiency anemia.

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The provided text describes the performance of the Bayer ADVIA 1650 device for eight different assays, comparing it to predicate devices. The studies establish the substantial equivalence of the ADVIA 1650 assays to already cleared devices.

Here's a breakdown of the requested information:

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

The document does not explicitly state pre-defined "acceptance criteria" in terms of specific thresholds for Total CV%, Syx, or R values that the ADVIA 1650 must meet. Instead, the approach is one of demonstrating substantial equivalence to predicate devices. The reported performance metrics (Imprecision, Correlation, Interfering Substances, Analytical Range, and Expected Values) are provided for each assay, and the assumption is that these align with or are comparable to the performance of the predicate devices.

However, we can infer performance ranges based on the provided data for the ADVIA 1650 for each method. The "acceptance criteria" are implicitly met if the performance is deemed substantially equivalent to the predicate.

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

• Sample Sizes (N for Correlation sections):
  • Apolipoprotein A-1: 78 (Serum: ARI), 72 (Plasma vs. Serum)
  • Apolipoprotein B: 59 (Serum: Tarrytown), 71 (Plasma vs. Serum)
  • CO2: 146 (Serum: Tarrytown), 79 (Plasma vs. Serum)
  • CRP: 56 (Serum: Tarrytown)
  • IgA: 74 (Serum: Tarrytown), 68 (EDTA Plasma vs. Serum), 69 (Heparin Plasma vs. Serum)
  • IgG: 60 (Serum: Tarrytown), 72 (EDTA Plasma vs. Serum), 73 (Heparin Plasma vs. Serum)
  • IgM: 74 (Serum: Tarrytown), 69 (EDTA Plasma vs. Serum), 70 (Heparin Plasma vs. Serum)
  • Transferrin: 78 (Serum: Tarrytown), 71 (EDTA Plasma vs. Serum), 72 (Heparin Plasma vs. Serum)
• Data Provenance: The studies were conducted at specific sites, primarily "Tarrytown" and "ARI." Based on the address provided for Bayer Corporation (Tarrytown, NY), the data provenance is likely United States. The document does not specify if the data was retrospective or prospective, but clinical correlation/imprecision studies for IVD devices are typically prospective or involve freshly collected samples for testing.

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 is not applicable to this type of in vitro diagnostic device study. The "ground truth" for the test set is established by the predicate device's measurement. These are quantitative assays, and the comparison is made against existing, cleared methods, not against expert human interpretation.

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

Not applicable. There is no human interpretation or adjudication involved in establishing truth for quantitative chemical assays comparing a new device to a predicate.

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

Not applicable. This is not an AI-assisted diagnostic imaging device. It's an in vitro diagnostic chemistry system.

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

Yes, the studies presented are standalone performance evaluations of the ADVIA 1650 device. The data provided (imprecision, correlation, interference) reflects the performance of the instrument and its reagents in measuring the specified analytes without direct human-in-the-loop diagnostic decisions being evaluated. The overall clinical utility is described in the "Intended Use" and "Expected Values" sections, assuming trained laboratory personnel operate the device.

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

For the correlation studies, the measurements from the predicate devices (e.g., Behring Nephelometer, Technicon DAX) served as the "comparison system" or reference for the ADVIA 1650 device. The predicate devices themselves would have established their accuracy and precision through their own clinical validation processes.

8. The sample size for the training set

The document does not explicitly state a "training set" size. For IVD devices, method validation studies typically involve method development and optimization (analogous to training) followed by performance verification (the studies reported here). The specific sample numbers used for developing the assays and optimizing parameters are not detailed in this summary. The sample sizes listed in point 2 are for the performance verification/test set studies.

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

As with the test set, the ground truth for any internal method development (if "training set" refers to samples used during that phase) would rely on reference methods or established laboratory standards for accurate analyte quantification. The document doesn't provide details on the specific "ground truth" establishment for method development. The focus is on demonstrating equivalence to legally marketed predicate devices.

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The SYNCHRON LX Systems Apolipoprotein A-1 (ApoA) reagent, when used in conjunction with SYNCHRON Systems APO CAL, is intended for the quantitative determination of human apolipoprotein A-1 in serum or plasma. This assay is designed for use with clinical chemistry analyzers from Beckman Instruments, such as the SYNCHRON LX™20 Clinical System.

The SYNCHRON LX Systems Apolipoprotein B (ApoB) reagent, when used in conjunction with SYNCHRON Systems APO CAL, is intended for the quantitative determination of human apolipoprotein B in serum or plasma. This assay is designed for use with clinical chemistry analyzers from Beckman Instruments, such as the SYNCHRON LX™20 Clinical System.

The SYNCHRON LX™ Systems Apolipoprotein ApoA and ApoB Reagents in conjunction with SYNCHRON Systems APO CAL, are intended for use on Beckman's SYNCHRON LX Clinical Systems.

The provided text describes the SYNCHRON LX™ Systems Apolipoprotein ApoA and ApoB Reagents. It details method comparison studies, imprecision data, and stability information. However, it does not explicitly state specific acceptance criteria in a quantifiable fashion that the device must meet. Instead, it presents performance data and implies that this data demonstrates substantial equivalence to predicate devices.

Therefore, I cannot fully complete the table for "Acceptance Criteria" as it is not explicitly provided in the document in a numerical, predefined target format. I will fill in the "Reported Device Performance" based on the study results.

Here is an analysis based on the information provided:

1. Table of (Implicit) Acceptance Criteria and Reported Device Performance

As stated, explicit numerical acceptance criteria are not presented in the document. The document's purpose is to demonstrate substantial equivalence to predicate devices and generally acceptable performance for in vitro diagnostic devices. The reported device performance is from method comparison and imprecision studies.

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The IMMAGE Immunochemistry System Apoliooprotein A-1 (APA) and B (APB) Reagents, in conjunction with Beckman Apolipoprotein Calibrator (APO Cal), are intended for use in the quantitative determination of apolipoprotein A-1 and B in human serum samples by nephelometric immunoassay. These assays are designed for use with the IMMAGE Immunochemistry System.

The IMMAGE System Apolipoprotein A-1 (APA) and B (APB) Reagents are designed for optimal performance on the IMMAGE Immunochemistry System. They are intended for use in the quantitative determination of apolipoprotein A-1 and B concentrations in human serum samples.

The provided document describes the safety and effectiveness of the IMMAGE Immunochemistry System Apolipoprotein A-1 (APA) and B (APB) Reagents. The study is a comparison to predicate devices, focusing on method comparison, stability, and imprecision.

Here's an analysis of the acceptance criteria and study data based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" for each performance metric, but the "Summary of Performance Data" section implies that the presented results demonstrate substantial equivalence to the predicate devices. For a more formal acceptance criteria, one would typically expect predefined thresholds for slope, intercept, r-value, and imprecision (%CV). However, for the purpose of this analysis, we will interpret "device performance" as the reported results, benchmarked against the predicate devices.

Note: The "Acceptance Criteria" column above is inferred based on the goal of showing "substantial equivalence" to existing commercial distribution devices. For a regulatory submission, explicit numerical thresholds would typically be defined beforehand.

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

• Sample Size for Test Set: The document explicitly states the "Number of Results" for the imprecision study as 80 for each level (Level 1, Level 2, Level 3) for both APA and APB reagents. This sums to 240 measurements for APA and 240 for APB, totaling 480 individual results for the imprecision study. The sample size for the method comparison study (which produces the slope, intercept, and r-value) is not explicitly stated in the provided text.
• Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. It is implied to be a prospective study conducted by Beckman Instruments, Inc. for the purpose of demonstrating device performance.

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

This document describes a diagnostic reagent and system for quantitative determination of apolipoproteins, not an imaging device or a diagnostic algorithm requiring human expert interpretation. Therefore, the concept of "experts" establishing a "ground truth" for a test set in the conventional sense (e.g., radiologists interpreting images) does not directly apply here.

• Ground Truth Establishment: For in vitro diagnostic devices like this, "ground truth" is typically established by comparing the new device's results against a well-characterized and often established reference method (the predicate device in this case) or gravimetrically prepared standards for imprecision and linearity studies. The "experts" would be the laboratory personnel performing the experiments and verifying instrument calibration and control material concentrations. Their qualifications would typically involve appropriate clinical laboratory training and experience.

4. Adjudication Method for the Test Set

Adjudication methods (e.g., 2+1, 3+1) are typically used in studies involving subjective interpretation (e.g., image reading) where disagreement among experts needs resolution. This concept does not apply to the quantitative measurement of apolipoproteins by an immunochemistry system. The results are numerical values, and any discrepancies would be investigated through quality control, calibration checks, or re-testing.

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

No, an MRMC comparative effectiveness study was not done. MRMC studies are relevant for assessing the impact of a new diagnostic tool on human reader performance, particularly in fields like radiology where subjective interpretation is key. This document describes a quantitative in vitro diagnostic device, where the comparison is system-to-system, not human-reader-to-human-reader or human-reader-with-AI vs. human-reader-without-AI.

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

Yes, the studies presented (method comparison, stability, imprecision) represent standalone performance of the IMMAGE™ Immunochemistry System and its reagents. These studies evaluate the analytical performance of the device itself, providing quantitative results without direct human intervention in the result generation process (beyond initiating tests and quality control). The "human-in-the-loop" aspect for such a device would be a laboratory technician operating the instrument and interpreting the numerical output, but the performance data here is about the device's accuracy and precision in generating those numbers.

7. The Type of Ground Truth Used

For the method comparison study, the "ground truth" was essentially the measurements obtained from the predicate devices (Beckman Apolipoprotein A-1 Reagent on the ARRAY and Beckman Apolipoprotein B Reagent on the ARRAY). The study aimed to demonstrate substantial equivalence by showing a strong correlation and agreement between the new IMMAGE system and the established predicate.

For the imprecision study, the "ground truth" for the mean concentration values would be based on assigned values of control materials (e.g., derived from manufacturers' assays or reference methods), with the goal of demonstrating consistent and reproducible measurements around those values.

8. The Sample Size for the Training Set

The document does not describe the development of an algorithm or AI model that would require a "training set." This device is an immunochemistry system with specific reagents, not a machine learning or AI-based diagnostic tool. Therefore, the concept of a "training set" in this context is not applicable.

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

As explained in point 8, there is no "training set" for this type of device. The ground truth for validating the analytical performance involves comparison against established predicate methods and control materials with known values, as detailed in point 7.

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