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The Access® Toxo IgM assay is a paramagnetic-particle chemiluminescent immunoassay for the qualitative detection of anti-Toxoplasma IgM in adult human serum, using the Access® Immunoassay System. The Access® Toxo IgM assay is presumptive for the diagnosis of acute, recent, or reactivated Toxoplasma gondii infections in males and pregnant or non-pregnant females. It is recommended this assay be performed in conjunction with an anti-Toxoplasma gondii IgG antibody assay.

The Access® Toxo IgM assay is a paramagnetic-particle chemiluminescent immunoassay for the qualitative detection of anti-Toxoplasma IgM in adult human serum, using the Access® Immunoassay System. The Access® Toxo IgM assay is presumptive for the diagnosis of acute, recent, or reactivated Toxoplasma gondii infections in males and pregnant or nonpregnant females. It is recommended this assay be performed in conjunction with an anti-Toxoplasma gondii IgG antibody assay.

The acceptance criteria for the Beckman Instruments ACCESS® Toxo IgM assay and its reported performance are described below based on the provided document.

1. Table of Acceptance Criteria and Reported Device Performance

The study concluded that the device is "substantially equivalent to the Platelia® Toxo IgM assay currently in commercial distribution." This implies that the observed performance metrics (sensitivity, specificity, precision) were deemed acceptable in comparison to the predicate device.

2. Sample Size and Data Provenance for the Test Set

• Sample Size: 822 patient serum samples.
• Data Provenance: Not explicitly stated, but the predicate device (Platelia® Toxo IgM Sanofi Diagnostics Pasteur, Inc.) is noted as being from France. It is not specified if the samples themselves were from France or other regions, nor is it explicitly stated if the data was retrospective or prospective for the initial comparison. However, one specific performance metric is reported "In a prospective population with a prevalence of 1.25% (5/400)," indicating at least a portion of the data was prospective for that specific analysis.

3. Number of Experts and Qualifications for Ground Truth

The document does not explicitly state the number or qualifications of experts used to establish ground truth for the test set.

4. Adjudication Method for the Test Set

The document mentions "After discrepancy analysis" for resolved sensitivity and specificity. However, it does not specify the adjudication method used (e.g., 2+1, 3+1, none). The "consensus result" is mentioned for the specificity in the prospective population, suggesting some form of expert agreement or a reference standard was used.

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

No MRMC comparative effectiveness study is mentioned. The study compares the performance of the ACCESS® Toxo IgM assay to a predicate device (Platelia® Toxo IgM assay), not the improvement of human readers with vs. without AI assistance.

6. Standalone Performance

Yes, the study evaluated the standalone performance of the ACCESS® Toxo IgM assay by comparing its qualitative detection of anti-Toxoplasma IgM to a legally marketed predicate device (Platelia® Toxo IgM). The reported sensitivity, specificity, and precision values are measures of its standalone analytical performance.

7. Type of Ground Truth Used

The primary ground truth for the initial comparison was the performance of the predicate device, Platelia® Toxo IgM. In a specific prospective population analysis, "a consensus result" was used as the ground truth. This suggests a combination of a comparative reference (predicate device) and potentially expert consensus for certain analyses.

8. Sample Size for the Training Set

The document does not provide information on a separate training set or its sample size. The clinical studies mentioned describe the evaluation of the device's performance against a predicate and a consensus in patient samples, which typically corresponds to a validation or test set rather than a training set for an algorithm. This is a diagnostic assay, not an AI/ML algorithm that requires a separate training set.

9. How Ground Truth for the Training Set Was Established

As there is no mention of a training set for an AI/ML algorithm (this is an immunoassay), this information is not applicable.

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The ACCESS® Free T4 Assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of free thyroxine levels in human or plasma (heparin) using the ACCESS® Immunoassav System. A free thyroxine test system is a device intended to measure free (not protein bound) thyroxine (thyroid hormone) in human serum or plasma (heparin). Levels of free thyroxine in plasma are thought to reflect the amount of thyroxine hormone available to the cells and may therefore determine the clinical metabolic status of thyroxine. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases.

The ACCESS® Free T4 reagents and the ACCESS® Immunoassay Analyzer comprise the ACCESS® Immunoassay System for the quantitative determination of free thyroxine in human serum or plasma (heparin).

The provided document describes the ACCESS® Free T4 assay, an in vitro diagnostic device, and its substantial equivalence to a predicate device for the quantitative determination of free thyroxine. Since this is an in vitro diagnostic device, the acceptance criteria and study designs are different from a typical AI/ML-based medical device that processes images or other patient data. The concepts of "human readers," "AI assistance," "ground truth," "training set," and "test set" in the context of AI/ML are not directly applicable here.

However, I can extract the closest analogous information from the document to answer your questions as best as possible, interpreting the studies described for an in vitro diagnostic device.

Here's a breakdown based on the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

For in vitro diagnostics, "acceptance criteria" usually refer to established performance characteristics that demonstrate the device is fit for its intended use and comparable to existing methods. "Reported device performance" refers to the results obtained from studies evaluating these characteristics.

Note: The acceptance values for these criteria (e.g., what an acceptable r-value or %CV range is) are not explicitly stated in the provided document but are implied by the FDA's clearance based on the reported performance demonstrating substantial equivalence. The predicate device's performance would serve as an implicit benchmark for these.

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

• Test Set Sample Size: 327 samples were used for the correlation study to compare the ACCESS® Free T4 assay with the predicate device (Abbott IMx® Free T4 assay).
• Data Provenance: Not explicitly stated (e.g., country of origin). The document does not specify if the samples were retrospective or prospective, or from a specific demographic.

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

This concept is not directly applicable to an in vitro diagnostic device like the ACCESS® Free T4 assay, which measures a biochemical marker. The "ground truth" for these devices is typically established through a combination of:

• Reference methods or established predicate devices (as seen in the correlation study).
• Certified calibrators and controls with known analyte concentrations.
• The inherent biochemical process being measured.

There are no "experts" in the sense of human readers/interpreters establishing ground truth for the measurement itself.

4. Adjudication Method for the Test Set

Not applicable. This concept is relevant for studies where human interpretation is involved and discrepancies need to be resolved. For an IVD, the measurement output is quantitative.

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

No, an MRMC comparative effectiveness study was not done. These types of studies are typically performed for imaging or interpretation-based diagnostic devices where multiple human readers evaluate cases, potentially with and without AI assistance, to assess improvements in diagnostic accuracy or efficiency.

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

Yes, the studies described are essentially "standalone" performance evaluations for the in vitro diagnostic device.

• Precision studies: Evaluate the inherent reproducibility of the device's measurements.
• Analytical Sensitivity: Determines the lowest quantifiable level for the device.
• Correlation study: Compares the device's quantitative outputs directly against those of a predicate device.

The ACCESS® Free T4 assay is a fully automated measurement system (immunoassay analyzer) that provides a quantitative result without direct human interpretation in the measurement process. "Human-in-the-loop" would refer to a scenario where a human modifies or interprets the device's direct output to reach a final diagnosis, which is not the primary function being evaluated here for the measurement system itself. The human-in-the-loop aspect for such devices is typically in the clinician's interpretation of the result in the context of the patient's clinical picture.

7. The Type of Ground Truth Used

For the correlation study, the "ground truth" was established by the results from the predicate device, the Abbott IMx® Free T4 assay. For precision and sensitivity, the "ground truth" relies on the known concentrations of controls and calibrators, which are themselves traceable to established reference methods or standards.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of AI/ML development. For an in vitro diagnostic device, the development process might involve numerous samples for assay optimization, reagent formulation, and initial validation. However, this is distinct from "training data" for an AI algorithm. The 327 samples for the correlation study and the samples used for precision and sensitivity are considered "test" or "validation" samples in this context.

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

Not applicable, as there is no explicitly defined "training set" in the AI/ML sense for this in vitro diagnostic device. The "ground truth" for developing such assays involves chemical and biological analyses, calibration standards, and comparison to existing validated methods during the development and optimization phases.

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The IMMAGE Immunochemistry System Valproic Acid (VPA) Reagent, when used in coniunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Drug Calibrator 1, is intended for the quantitative determination of valproic acid in human serum or plasma by rate nephelometric inhibition immunoassay.

The IMMAGE Immunochemistry System VPA Reagent in conjunction with Beckman Drug Calibrator 1, is intended for use in the quantitative determination of valproic acid in human serum or plasma on Beckman Coulter's IMMAGE Immunochemistry Systems.

The provided text describes the IMMAGE® Immunochemistry System Valproic Acid (VPA) Reagent and outlines the performance data used to demonstrate its safety and effectiveness. However, it does not explicitly state "acceptance criteria" in a quantitative manner or provide a detailed study report that proves the device meets specific, pre-defined acceptance criteria with quantifiable results.

The document primarily focuses on demonstrating "substantial equivalence" to a predicate device through method comparison, stability, and imprecision experiments, as required for a 510(k) submission. While performance data is presented, it's not structured as a direct comparison against a set of stated acceptance criteria.

Therefore, the following response will extract the available performance data and highlight the limitations in directly answering all parts of your request based on the provided text.

Here's the analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" against which the device's performance is measured. Instead, it presents performance data (Method Comparison and Imprecision) that are implicitly compared against the performance of the predicate device (Abbott TDx Valproic Acid Reagent) to demonstrate substantial equivalence.

Table: Available Performance Data (No Explicit Acceptance Criteria)

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

Due to the unreadable nature of the "Method Comparison Study Results" and "Estimated Imprecision" sections, specific sample sizes for these test sets cannot be determined from the provided text.

• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The studies are implied to be internal validation studies conducted by Beckman Coulter, Inc.

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

This information is not provided in the document. For an immunochemistry system that quantifies a substance in blood, the "ground truth" would typically be established by a reference method or a highly accurate gold standard assay, not by human expert interpretation.

4. Adjudication Method for the Test Set

This information is not applicable as the ground truth for this type of device is established by quantitative laboratory methods, 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. The device is an immunochemistry system for quantitative determination of valproic acid, not an AI-assisted diagnostic imaging or interpretation tool involving human readers.

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

The device is described as an "Immunochemistry System Valproic Acid (VPA) Reagent" for use on the "IMMAGE® Immunochemistry Systems." This implies a standalone diagnostic test performed by the instrument. There is no mention of human interpretation being part of the primary assay result generation process. Therefore, the standalone performance is what is being reported (though specific values for method comparison and imprecision are unreadable).

7. The Type of Ground Truth Used

The ground truth for this type of quantitative assay would typically be established by:

• Reference Method: Comparison against a widely accepted and highly accurate reference method (e.g., Gas Chromatography-Mass Spectrometry (GC-MS) or Liquid Chromatography-Mass Spectrometry (LC-MS) for drug levels).
• Predicate Device Comparison: As stated in the document, "Equivalence is demonstrated through method comparison, stability, and imprecision experiments," implicitly using the TDx® Valproic Acid (VPA) from Abbott Laboratories as a comparative "gold standard" or predicate for performance evaluation.

The document explicitly mentions a "Method Comparison Study" against the predicate device, suggesting the predicate device's results served as the comparative 'truth' in the context of demonstrating substantial equivalence.

8. The Sample Size for the Training Set

This information is not provided in the document. For a traditional immunoassay system, there isn't a "training set" in the machine learning sense. The assay is developed and validated through laboratory experiments, calibration, and QC procedures.

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

As there is no "training set" in the machine learning context for this device, this question is not applicable. The 'ground truth' for the development and validation of such a system would involve precise preparation of known concentration samples and characterization of reagents and system performance through a rigorous analytical chemistry process. Calibration is performed using "Beckman Drug Calibrator 1," which would have its concentrations established by a trusted reference method.

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The Access® AFP assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of alpha-fetoprotein (AFP) in human serum using the Access Immunoassay System. AFP measured by the Access AFP Immunoassay, is used as an aid in the management of patients with nonseminomatous testicular cancer.

The ACCESS® AFP Immunoassay Reagents and the ACCESS® Immunoassay Analyzer comprise the ACCESS® Immunoassay System for the quantitative determination of AFP in human serum.

{
  "acceptance_criteria_and_study": {
    "table_of_performance": [
      {
        "criterion": "Correlation with Predicate Device (Abbott IMx AFP assay)",
        "acceptance_criteria": "Not explicitly stated, but typically highly correlated (e.g., r > 0.95 and slope near 1, intercept near 0)",
        "reported_performance": "r = 0.99; y = 0.91x + 3.86 (indicating very good agreement)"
      },
      {
        "criterion": "Expected Range (Healthy individuals)",
        "acceptance_criteria": "Typically, a high percentage of healthy individuals should fall within a defined reference range.",
        "reported_performance": "98.9% of 177 healthy individuals had AFP values ≤ 9.0 ng/mL. 1.1% had values in the 9.1 to 15 ng/mL range."
      },
      {
        "criterion": "Monitoring Data (Nonseminomatous Testicular Cancer Patients)",
        "acceptance_criteria": "High concordance with predicate device results and concurrent clinical assessment in monitoring patient status.",
        "reported_performance": "Results were highly concordant to both the IMx AFP results and concurrent clinical assessment."
      },
      {
        "criterion": "Recovery (Linearity studies)",
        "acceptance_criteria": "Typically a range of 90-110% recovery.",
        "reported_performance": "96 to 110% recovery for diluted samples."
      },
      {
        "criterion": "Recovery (Spiked samples)",
        "acceptance_criteria": "Typically a range of 90-110% recovery.",
        "reported_performance": "Average 99% recovery, with individual recoveries ranging from 90 to 108%."
      },
      {
        "criterion": "Precision (Assay imprecision)",
        "acceptance_criteria": "Typically less than a specified percentage (e.g., <10%, <15%).",
        "reported_performance": "<6% for AFP concentrations from 6.5 to 1680 ng/ml."
      },
      {
        "criterion": "Specificity",
        "acceptance_criteria": "No significant interference from potential biological substances, therapeutic drugs, or cross-reacting substances.",
        "reported_performance": "No significant interference."
      },
      {
        "criterion": "Analytical Sensitivity (Lowest detectable level)",
        "acceptance_criteria": "A specific low concentration value that is distinguishable from zero with a high confidence level.",
        "reported_performance": "0.5 ng/ml (distinguishable from zero with 95% confidence)."
      }
    ],
    "sample_size_test_set_and_data_provenance": {
      "correlation_study": {
        "sample_size": "170 samples",
        "data_provenance": "Not specified (retrospective or prospective, country of origin not mentioned)."
      },
      "expected_range_study": {
        "sample_size": "177 apparently healthy males and females",
        "data_provenance": "Not specified (retrospective or prospective, country of origin not mentioned)."
      },
      "monitoring_data_study": {
        "sample_size": "Longitudinal samples from previously diagnosed nonseminomatous testicular cancer patients (number not specified)",
        "data_provenance": "Not specified (retrospective or prospective, country of origin not mentioned)."
      },
      "recovery_studies": {
        "sample_size": "Not specified (number of human serum samples or spiked samples)",
        "data_provenance": "Not specified."
      },
      "precision_study": {
        "sample_size": "Not specified (number of samples tested for precision)",
        "data_provenance": "Not specified."
      },
      "specificity_study": {
        "sample_size": "Not specified (number of substances/drugs tested)",
        "data_provenance": "Not specified."
      },
      "analytical_sensitivity_study": {
        "sample_size": "Not specified",
        "data_provenance": "Not specified."
      }
    },
    "ground_truth_experts_test_set": {
      "correlation_monitoring_expected_range": "Not applicable, as these studies primarily compared measurements against a predicate device or established reference ranges, not against a new 'ground truth' established by experts in the context of image analysis, for example.",
      "qualifications": "Not applicable."
    },
    "adjudication_method_test_set": "Not applicable, as this is a quantitative immunoassay and not reliant on expert review of ambiguous cases.",
    "mrmc_comparative_effectiveness_study": "No, this is an in-vitro diagnostic device for quantitative measurement of alpha-fetoprotein (AFP) and not an imaging device or algorithm requiring human reader interpretation or assistance. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study with AI assistance is not relevant.",
    "standalone_performance_study": "Yes, all the described studies (correlation, expected range, monitoring data, recovery, precision, specificity, analytical sensitivity) demonstrate the standalone performance of the ACCESS® AFP Immunoassay. The assay directly measures AFP levels in serum.",
    "type_of_ground_truth_used": {
      "correlation_study": "The Abbott IMx AFP assay (predicate device) served as the reference for comparison.",
      "expected_range_study": "Statistical distribution of AFP values in an 'apparently healthy' population.",
      "monitoring_data_study": "Abbott IMx AFP assay results and 'concurrent clinical assessment' provided the reference for concordance.",
      "recovery_precision_specificity_analytical_sensitivity": "Defined analytical standards, known spiked concentrations, and reference materials were used."
    },
    "sample_size_training_set": "Not applicable, as this is a chemical immunoassay, not a machine learning model that requires a training set in the conventional sense. The 'training' for the assay involves internal calibration and reagent optimization by the manufacturer.",
    "ground_truth_training_set_establishment": "Not applicable for the reasons stated above. The immunoassay itself is based on chemical reactions and detection, not a learned algorithm from a training dataset."
  }
}

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The ACCESS® Total βhCG assay is a paramagnetic-particle, chemiluminescent immunoassay for the quantitative determination of total βhCG in human serum, using the the ACCESS® Immunoassay System.

The Access® Total BhCG reagents and the Access® Immunoassay Analyzer comprise the Access® Immunoassay System for the quantitative determination of total βhCG levels in human serum.

The document describes the acceptance criteria and supporting studies for the Access® Total βhCG assay.

Here's a breakdown of the requested information:

1. Table of acceptance criteria and the reported device performance:

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

• Correlation Study (comparison with predicate): 119 human serum samples.
• Accuracy (Dilution Recovery): 2 human serum samples were diluted.
• Precision: Not explicitly stated how many samples were used, but multiple runs/measurements would be implied by CV calculation.
• Analytical Sensitivity: Data supports the lowest detectable level using Access® Total βhCG Calibrator S0.
• Analytical Specificity: Not specified.
• Data Provenance: The data used for these studies are described as "human serum samples." The document does not specify the country of origin of the data, nor does it explicitly state whether the study was retrospective or prospective. Given the nature of these types of lab validation studies, they are typically prospective evaluations of samples.

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

This device is an in-vitro diagnostic (IVD) assay used for the quantitative determination of βhCG. The "ground truth" for this type of device is established by the known concentration of βhCG in control materials or by comparison with a well-established and standardized reference method. The document does not mention human expert adjudication for establishing ground truth in the context of image interpretation or subjective assessments. Instead, it refers to:

• Standardization: "Both assays are standardized to the WHO 3rd IS 75/537 standard." This international standard serves as the "ground truth" for hCG concentration.
• Predicate Device Comparison: The ACS:180 Total hCG +B assay acts as a comparative reference, implying its results are considered a form of "ground truth" for comparison purposes.

Therefore, no human experts (e.g., radiologists) were used in the way one might for diagnostic imaging studies, as the ground truth is based on biochemical standards and established comparative assays.

4. Adjudication method for the test set:

Not applicable in the context of this IVD device. "Adjudication" usually refers to resolving discrepancies between multiple human readers or a human reader and an AI. For this quantitative immunoassay, the "ground truth" is determined by reference standards and established analytical methods, not human opinion or consensus.

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 AI-assisted diagnostic imaging or human-in-the-loop system. Therefore, MRMC studies and "improvement with AI vs without AI assistance" are not relevant to this device.

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

Yes, the studies describe the performance of the Access® Total βhCG assay as a standalone system (algorithm/reagent-only) when run on the Access® Immunoassay Analyzer. The results reported for precision, accuracy, analytical sensitivity, and specificity represent the performance of the device without human interpretation or intervention beyond the standard operation of the instrument.

7. The type of ground truth used:

The ground truth for this device's performance studies relies on:

• Reference Standards: The WHO 3rd IS 75/537 standard for hCG concentration.
• Known Concentrations: In spiked samples or controls for dilution recovery.
• Comparative Reference Method: The ACS:180 Total hCG +B assay is used as a comparative "ground truth" for correlation studies.
• Analytical Definitions: For sensitivity (lowest detectable level) and specificity (cross-reactivity with other hormones).

8. The sample size for the training set:

The document does not describe a "training set" in the context of machine learning. This is an immunoassay, not a machine learning algorithm that requires a separate training set. The assay's performance characteristics (e.g., calibration curves, sensitivity parameters) are established through a validation process, but this is distinct from training a machine learning model.

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

Not applicable, as there is no "training set" in the machine learning sense for this immunoassay. The standardization of the assay's calibration curve and parameters would be established by running known concentrations of calibrators (e.g., Access® Total βhCG Calibrator S0).

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The Access® PSA assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of prostate-specific antigen (PSA) in human serum using the ACCESS Immunoassay System. PSA measured by the Access PSA Immunoassay, is used as an aid in the management of patients with prostate cancer.

The ACCESS® PSA Immunoassay Reagents and the ACCESS® Immunoassay Analyzer comprise the ACCESS® Immunoassay System for the quantitative determination of PSA in human serum.

The provided document describes a 510(k) submission for the ACCESS® PSA Assay, which is intended for quantitative determination of Prostate-Specific Antigen (PSA) in human serum and for use as an aid in the management of patients with prostate cancer. The acceptance criteria and supporting studies are presented in comparison to a predicate device, the Tandem®-R PSA assay.

Here's a breakdown of the requested information:

1. Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria in a quantitative manner for all parameters, but rather demonstrates performance by comparing to a predicate device and presenting observed results. For the purpose of this analysis, the "reported device performance" are the results achieved in the described studies, implying these met the implicit acceptance criteria for substantial equivalence to the predicate device.

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

• Correlation: 293 samples
• Expected Range: Population of apparently healthy males (exact number not specified)
• Monitoring Data: 127 monitoring samples from a total of 29 previously diagnosed prostate cancer patients.

Data Provenance: The document does not explicitly state the country of origin. It is a retrospective analysis from "previously diagnosed prostate cancer patients" for monitoring data and "a population of apparently healthy males" for expected range. For correlation, it involved samples "run with both the ACCESS® PSA Immunoassay and the Tandem®-R PSA assay," implying collected samples.

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

The document does not specify the number or qualifications of experts used to establish ground truth for the test set.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the test set. The clinical assessment mentioned for monitoring data would inherently involve expert opinion, but no specific adjudication process (e.g., 2+1) is detailed.

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

No. This document does not describe an MRMC comparative effectiveness study involving human readers. It focuses on the analytical performance of the assay itself compared to a predicate device and clinical assessment, not on how human interpretation of results might be improved 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 evaluations of the ACCESS® PSA Immunoassay system. The results presented (correlation, expected range, recovery, precision, specificity, analytical sensitivity) characterize the sensor/algorithm performance directly without human-in-the-loop interaction in the measurement itself. The "monitoring data" section notes that results were compared to "concurrent clinical assessment or predicted the subsequent clinical assessment," which reflects the assay's utility in a clinical context, but the assay itself is standalone.

7. The Type of Ground Truth Used

• Correlation: The predicate device (Tandem®-R PSA assay) served as the reference standard for comparison.
• Expected Range: Statistical distribution within a defined population of "apparently healthy males."
• Monitoring Data: Reference was against the predicate device's results and "concurrent clinical assessment or predicted the subsequent clinical assessment," implying clinical diagnosis/progression as determined by clinicians.
• Recovery/Precision/Specificity/Analytical Sensitivity: These are intrinsic analytical performance measures, where "ground truth" is established by controlled experiments (e.g., known spikes of PSA, defined sample matrices for specificity).

8. The Sample Size for the Training Set

The document does not provide details about a specific "training set" or its size. This is a 510(k) submission for an in-vitro diagnostic device, not typically a machine learning algorithm that undergoes traditional "training" in the same sense. The development and validation phases would involve various samples used for assay optimization and calibration, but these are not explicitly referred to as a "training set" in this context.

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

As noted above, the concept of a "training set" for a machine learning algorithm with established ground truth is not explicitly applicable here. For the development and calibration of the immunoassay, ground truth would have been established through:

• Known concentrations: For calibrators and controls used to create standard curves and validate linearity.
• Reference materials: Utilizing certified reference materials or highly characterized samples for method development and optimization.
• Comparison to reference methods: Performance during development would be benchmarked against existing, established PSA measurement techniques.

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The IMMAGE Immunochemistry System AlphaMacroglobulin (AMG) Reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Calibrator 2, is intended for the quantitative determination of human alpha macroglobulin by rate nephelometry. Measurement of alpha_macroglobulin may aid in the diagnosis of blood-clotting or clot lysis disorders.

The IMMAGE Immunochemistry System AMG Reagent, in conjunction with Beckman Calibrator 2, is intended for use in the quantitative determination of Alpha-Macroglobulin concentrations on Beckman's IMMAGE Immunochemistry System.

This is an in vitro diagnostic device, not an AI/ML device. Therefore, the questions related to AI/ML device studies, such as the use of experts for ground truth, adjudication methods, MRMC studies, and training set information, are not applicable.

Here's a breakdown of the available information:

Acceptance Criteria and Device Performance

The submission primarily focuses on establishing "substantial equivalence" to a predicate device, as opposed to defining explicit performance acceptance criteria with numerical targets. Equivalence is demonstrated through "method comparison, stability, and imprecision experiments."

1. Table of Acceptance Criteria and Reported Device Performance

Note: The provided document does not explicitly state numerical acceptance criteria. Instead, it refers to the demonstration of "substantial equivalence" through method comparison, stability, and imprecision experiments. Therefore, the "Reported Device Performance" is inferred from the results presented as part of demonstrating this equivalence, rather than direct numerical comparisons to pre-defined thresholds.

2. Sample Size and Data Provenance for Test Set

• Sample Size for Test Set: Not explicitly stated in the provided text for method comparison, stability, or imprecision studies. The tables showing "Method Comparison Study Results," "Stability Study Results," and "Estimated Imprecision" are largely corrupted and do not provide clear numerical data on sample sizes.
• Data Provenance: Not explicitly stated. Given that it's a Beckman Instruments submission, it's likely internal company data, but the geographical origin or whether it's retrospective or prospective is not mentioned.

3. Number of Experts and Qualifications for Ground Truth

• Not Applicable. This is an in vitro diagnostic device measuring a quantitative analyte, not an AI/ML device requiring expert interpretation for ground truth establishment. The "ground truth" for such devices typically refers to the true concentration of the analyte, often determined by reference methods or gravimetric preparation of calibrators/controls.

4. Adjudication Method

• Not Applicable. As this is an in vitro diagnostic device measuring a quantitative analyte, an adjudication method (like 2+1 or 3+1 used for expert consensus in image interpretation) is not relevant.

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

• Not Applicable. This is an in vitro diagnostic device, not an AI/ML system that assists human readers. Therefore, an MRMC study is not relevant.

6. Standalone Performance Study (Algorithm Only)

• Yes, in spirit. The performance data presented (method comparison, stability, imprecision) assesses the "algorithm only" in the sense that it measures the performance of the IMMAGE Immunochemistry System AMG Reagent as a standalone diagnostic assay on the IMMAGE system, without human interpretive input that would be common in AI/ML clinical decision support. The device is intended for quantitative determination by rate nephelometry, which is an automated process.

7. Type of Ground Truth Used

• For Method Comparison: The ground truth is established by the predicate device (Beckman Alpha₂-Macroglobulin (AMG) using the Array System) or another established method against which the new device's results are compared.
• For Stability and Imprecision: The ground truth is typically the known concentration of the analyte in control materials or patient samples, or the expected measurement derived from robust, repetitive testing.

8. Sample Size for Training Set

• Not Applicable. This is an in vitro diagnostic device with reagents and a defined measurement principle (rate nephelometry), not a machine learning algorithm that requires a "training set" in the AI/ML sense. Data is used for characterization, calibration, and validation rather than training a model.

9. How Ground Truth for Training Set Was Established

• Not Applicable. See reasoning for "Sample Size for Training Set."

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The IMMAGE Immunochemistry System Antithrombin III (AT3) Reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Calibrator 2, is intended for the quantitative determination of human Antithrombin III by rate nephelometry.

The IMMAGE Immunochemistry System AT3 Reagent, in conjunction with Beckman Calibrator 2, is intended for use in the quantitative determination of Antithrombin III concentrations on Beckman's IMMAGE Immunochemistry System.

The provided document describes the IMMAGE™ Immunochemistry System Antithrombin III (AT3) Reagent. The acceptance criteria and supporting study details are summarized below.

1. Table of Acceptance Criteria and Reported Device Performance

The document implicitly uses the performance of the predicate device (Array System Antithrombin III (AT3) Reagent) as the acceptance criteria for the IMMAGE System AT3 Reagent. The key performance metrics evaluated are method comparison (correlation with the predicate), stability, and imprecision.

2. Sample Size for the Test Set and Data Provenance

• Sample Size: N = 136 for the method comparison study.
• Data Provenance: The document does not explicitly state the country of origin. It is a retrospective study as it compares the new device's results to an existing, commercially available predicate device using collected samples. The "plasma" sample type is mentioned.

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

This device is an in-vitro diagnostic (IVD) for quantitative determination of Antithrombin III. The "ground truth" for such devices is typically established through direct measurement on samples where the analyte concentration is known or determined by a well-established, often reference, method.

• Number of Experts: Not applicable in the context of expert consensus for image review or clinical diagnosis. The ground truth for the method comparison was established by the predicate device (Array 360 System AT3 Reagent), which itself is a laboratory instrument.
• Qualifications of Experts: Not applicable. The "ground truth" here is the measurement from the predicate device.

4. Adjudication Method for the Test Set

The concept of an adjudication method (e.g., 2+1, 3+1) is typically relevant for studies where human interpretation of medical images or clinical data is involved and discrepancies between readers need to be resolved. For an IVD device like the IMMAGE AT3 Reagent, the "adjudication" is essentially the statistical comparison of the new device's output against the predicate device's output. There is no mention of a human adjudication process for resolving discordant results between the IMMAGE system and the Array system; rather, a statistical correlation (regression analysis) is performed.

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

• Was an MRMC study done? No. This type of study is not applicable for this device. MRMC studies are designed to assess diagnostic performance with and without AI assistance for human readers, typically in image interpretation. The IMMAGE AT3 Reagent is an automated in-vitro diagnostic system that quantifies a biomarker, not an imaging device or an AI assistant for human interpretation.

6. Standalone (i.e. algorithm only without human-in-the-loop performance) Study

• Was a standalone study done? Yes. The performance data presented (method comparison, stability, imprecision) appears to be for the IMMAGE AT3 Reagent operating as a standalone system (algorithm only) without direct human-in-the-loop diagnostic interpretation that would alter its output. The system measures Antithrombin III concentrations, and its accuracy is assessed against a predicate device.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth for the performance evaluation (method comparison) was established by the results obtained from a legally marketed predicate device: the Array 360 System AT3 Reagent. This is a form of "reference method" in the context of IVD devices for quantitative analytes.

8. Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of machine learning or AI algorithm development. This device, being an immunochemistry system, likely relies on established biochemical reaction principles and calibration curves rather than machine learning algorithms trained on large datasets. Therefore:

• Sample Size for Training Set: Not applicable or not specified, as the device doesn't appear to be based on an AI/ML model requiring a training set in the conventional sense. Its performance is validated through analytical studies (method comparison, stability, imprecision).

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

As noted above, the concept of a "training set" with ground truth in the AI/ML context doesn't appear to apply directly to this device. The system's operation is based on rate nephelometry and calibrated using a specific calibrator (Beckman Calibrator 2). The establishment of the calibrator values would involve a separate, rigorous process, likely traceable to a reference standard, but this is distinct from establishing ground truth for an AI training set.

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Beckman's Vigil Lipid Control is intended for use in monitoring the reliability of automated in vitro diagnostic assays of total cholesterol, HDL cholesterol (HDLc), triglycerides, apolipoprotein A-1 and apolipoprotein B in the clinical laboratory. The use of three or more levels of control allows the laboratorian to monitor change in calibration linearity along with analytical error and imprecision.

The VIGIL™ Lipid Controls are four level ready-to-use human serum-based liquid controls manufactured by Beckman Instruments, Inc. Each kit contains 4 X 4 mL bottles of a single level of control.

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

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

The document does not explicitly state a "test set" in the traditional sense of evaluating diagnostic accuracy. Instead, the performance data provided is limited to stress stability studies.

• Sample size: Not explicitly stated as a number of control samples. The studies involve measuring stability at various temperatures for different durations.
• Data Provenance: Not specified, but likely internal Beckman Instruments testing given the context of a 510(k) submission. Retrospective or prospective is not explicitly mentioned, but stability studies are typically prospective, designed to evaluate product degradation over time.

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

Not applicable. This device is a quality control material, not a diagnostic device that interprets clinical data or images. The "ground truth" for a quality control material is its assigned value(s) for the analytes it contains, which is established through a value assignment process. The document states this process is "Same as the predicate." Further details on how these values are established (e.g., use of reference methods, certified reference materials) are not provided.

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

Not applicable. As noted above, this is a quality control material, not a diagnostic device requiring interpretive 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

Not applicable. This device is a quality control material and does not involve human readers or AI assistance.

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

Not applicable. This is a quality control material for laboratory assays, not an algorithm.

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

The "ground truth" for the VIGIL™ Lipid Controls refers to the assigned values of the individual analytes (total cholesterol, HDL cholesterol, triglycerides, apolipoprotein A-1, and apolipoprotein B) contained within the control material. The document explicitly states that the "Value Assignment" process is "Same as the predicate." While the specifics of this process are not detailed, for quality control materials, this typically involves:

• Target Values: Established through analysis on highly accurate and precise reference methods or instruments, often linked to international reference materials.
• Interlaboratory Consensus: Participation in interlaboratory proficiency testing programs where target values are determined by consensus of multiple expert laboratories using reference methods.

8. The sample size for the training set

The document does not refer to a "training set" in the context of machine learning. The studies described are performance studies for a quality control material, specifically shelf-life stability.

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

Not applicable, as there is no "training set" in the machine learning sense for this device.

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CAL 2 (Calibrator 2), when used in conjunction with Beckman alpha,-antitrypsin (AAT), ceruloplasmin (CER), properdin factor B (PFB), beta-2-microglobulin (B2M), alphamacroglobulin (AMG) and antithrombin III (AT3) reagents, is intended for used on Array®, Array® 360, and IMMAGE™ Systems for the calibration of these reagents.

Beckman Calibrator 2 is derived from fresh frozen human plasma that has been defibrinated and processed. Assay of CAL 2 provides a response value that is utilized for the adjustment of pre-programmed calibration curves from which AAT, CER, PFB, B2M, AMG, and AT3 concentration values are determined for test specimens.

The provided document is a 510(k) summary for the Beckman Calibrator 2 (CAL2), a device used for calibrating diagnostic instruments. It describes the device's intended use and compares it to predicate devices. However, this document does not contain the detailed study results, acceptance criteria, or performance data typically associated with studies proving a device meets specific acceptance criteria for diagnostic accuracy metrics (e.g., sensitivity, specificity, AUC) or human reader performance with AI assistance.

The document states: "The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to chemistry test systems already in commercial distribution. The value assignment process for each analyte is correlated to a known standard via the anchor method. The Beckman Calibrator 2 value assignment and verification processes yield acceptable calibrator assigned values for calibration on the Array® and IMMAGE™ Systems."

This indicates that internal testing was conducted to ensure the calibrator's values were acceptable and correlated to known standards, consistent with establishing substantial equivalence to existing predicate devices. However, it does not provide the specific numerical acceptance criteria or the raw performance data from such a study.

Therefore, much of the requested information cannot be extracted from this specific document.

Here's an attempt to answer the questions based only on the provided text, highlighting what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not specified in the document.
• Data Provenance: Not specified in the document (e.g., country of origin, retrospective or prospective). The document only mentions "The data in the Premarket Notification."

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

• Not applicable/Not specified. This device is a calibrator for in-vitro diagnostic tests, not an interpretive AI device for medical images or clinical decision support that would typically involve expert ground truth establishment for a test set in the same way. The ground truth for a calibrator would be an established reference standard or a method traceable to an international standard.

4. Adjudication Method for the Test Set

• Not applicable/Not specified. Adjudication methods like 2+1 or 3+1 are typically used for expert consensus on image interpretation or clinical diagnosis, which is not the primary function of a calibrator.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• No, an MRMC comparative effectiveness study was not done. This type of study involves human readers interpreting cases, often with and without AI assistance, to measure performance improvement. The Beckman Calibrator 2 is a diagnostic calibrator, not an AI-powered diagnostic tool used by human readers for interpretation.

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

• Yes, in spirit. The testing described (though lacking detail) focuses on the performance of the calibrator itself in assigning values and its compatibility with the instruments. This is analogous to a "standalone" performance evaluation of the calibrator's function, independent of human operators, beyond its intended use in calibrating the instrument. The "value assignment and verification processes" would be an assessment of the calibrator's intrinsic performance.

7. The Type of Ground Truth Used

• Known Standard / Anchor Method: The document states, "The value assignment process for each analyte is correlated to a known standard via the anchor method." This implies that the ground truth for the calibrator's values is established by comparing them to pre-defined, validated reference materials or methods.

8. The Sample Size for the Training Set

• Not applicable/Not specified. This is a calibrator, not an AI algorithm that undergoes "training" in the machine learning sense. Its values are assigned using a chemical process and verified against standards.

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

• Not applicable/Not specified, as this device does not have a "training set" in the context of AI. The "ground truth" for the calibrator's values is established through correlation to "known standards via the anchor method."

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