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Dimension Vista™ IGE Flex® reagent cartridge: The IGE method is an in vitro diagnostic test for the quantitative determination of Immunoglobulin E in human serum, heparinized plasma or EDTA plasma on the Dimension Vista® System. Measurements of IGE aid in the diagnosis of IgE mediated allergic disorders in conjunction with other clinical findings.

Dimension Vista™ Protein 1 Calibrator: PROT1 CAL is an in vitro diagnostic product for the calibration of the C3 Complement (C3), C4 Complement (C4), Immunoglobulin A (IGA), Immunoglobulin E (IGE), Immunoglobulin G (IGG), Immunoglobulin M (IGM), and Prealbumin (PREALB) methods on the Dimension Vista® System.

Dimension Vista™ Protein 1 Control L. M and H: PROT1 CON L, M and H are assayed intralaboratory quality controls for assessment of precision and analytical bias in the determination of C3 Complement (C3), C4 Complement (C4), immunoglobulin A (IGA), immunoglobulin E (IGE), immunoglobulin G (IGG), immunoglobulin M (IGM), and prealbumin (PREALB) on the Dimension Vista® System.

Dimension Vista™ IGE Flex® reagent cartridge: 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™ Protein 1 Calibrator: Protein 1 Calibrator is a multi-analyte, liquid, human serum based product containing C3 complement, C4 complement, immunoglobulin A (IGA), immunoglobulin E (IGE), immunoglobulin G (IGG), immunoglobulin M (IGM) and prealbumin (PREALB).

Dimension Vista™ Protein 1 Control L. M and H: Protein 1 Control L, M and H are multi-analyte, liquid, human serum based products containing C3 complement, C4 complement, immunoglobulin A (IGA), immunoglobulin E (IGE), immunoglobulin G (IGG), immunoglobulin M (IGM) and prealbumin (PREALB).

This submission describes the Dimension Vista™ IGE Flex® reagent cartridge, Dimension Vista™ Protein 1 Calibrator, and Dimension Vista™ Protein 1 Control L, M, and H for the quantitative determination of Immunoglobulin E (IgE). The study aimed to demonstrate equivalent performance to a legally marketed predicate device.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state pre-defined acceptance criteria in terms of specific thresholds for correlation coefficient, slope, or intercept. Instead, it implies that a strong correlation and "equivalent performance" between the new device and the predicate device would be considered acceptable. The reported performance is a regression analysis of the method comparison study.

Note: The document states, "These studies demonstrate correlation and equivalent performance between the Dade Behring N Latex IgE mono assay and the Dimension Vista " IGE assay." This statement, along with the high correlation coefficient, suggests the reported performance met the unstated equivalence criteria.

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

• Sample Size for Test Set: 120 serum and plasma samples.
• Data Provenance: The document does not explicitly state the country of origin. It indicates the samples were human serum and plasma. It doesn't specify if the data was retrospective or prospective, but method comparison studies are typically prospective or use banked retrospective samples to evaluate the new device against a predicate. Given the typical nature of device validation, it's likely these were distinct samples collected for the purpose of the comparison.

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

This type of in vitro diagnostic device (IVD) for quantitative measurement does not typically rely on "expert consensus" for ground truth in the same way an imaging or diagnostic AI model would.

• Ground Truth Establishment: The "ground truth" for the test set was established by running the samples on the predicate device, the Dade Behring N Latex IgE mono assay on the BN ProSpec® System.
• Number and Qualifications of Experts: Not applicable in the context of this type of quantitative IVD comparison. The performance of the predicate device serves as the reference, which has its own established accuracy and precision validated through previous studies.

4. Adjudication Method for the Test Set

Not applicable. The comparison involves quantitative measurements from two different analytical systems, not subjective interpretations requiring adjudication.

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

• Was an MRMC study done? No. This submission pertains to an in vitro diagnostic device for quantitative IgE measurement, which does not involve human readers interpreting cases or AI assistance in a diagnostic workflow. Therefore, an MRMC study is not relevant.
• Effect size of human readers improve with AI vs without AI assistance: Not applicable.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Was a standalone study done? Yes, in essence. The method comparison study directly evaluated the Dimension Vista™ IGE assay (algorithm/device only) against the predicate device. The output is a numerical value, and there is no human-in-the-loop interpretation or intervention in generating this primary result.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth for this comparison study was the quantitative IgE values obtained from the predicate device: the Dade Behring N Latex IgE mono assay on the BN ProSpec® System. This is a form of comparative reference measurement, where the established method (predicate) serves as the benchmark.

8. The Sample Size for the Training Set

• Sample Size for Training Set: The document does not explicitly mention a "training set" in the context of machine learning. For IVDs, the development and calibration of the assay (reagents, calibrators, controls) are typically done through extensive internal studies (which would involve numerous samples for optimization, calibration curve generation, and verification of analytical performance characteristics like linearity, precision, etc.) before the final method comparison study. The 120 samples discussed in the method comparison are best considered a validation/test set for the final, developed assay.

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

• Ground Truth Establishment for Training Set: Since a "training set" in the machine learning sense isn't explicitly described, the concept of ground truth for training would relate to the development and calibration of the assay itself. This would involve:
  • Reference materials: Using internationally recognized IgE reference materials or purified IgE standards with known concentrations for calibrating the assay and defining the optimal reagent formulation and reaction conditions.
  • Known samples: Running samples with previously established IgE concentrations (e.g., from other validated methods) to confirm the assay's ability to accurately measure them.
  • Analytical studies: Performing studies to establish linearity, limit of detection, precision, and other analytical performance characteristics, where "ground truth" is defined by the expected behavior of the assay with controlled samples.

The document focuses on the final validation of the Dimension Vista™ IGE assay against a predicate, rather than the developmental steps involving "training."

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Dimension Vista™ TRF Flex® reagent cartridge: The TRF method is an in vitro diagnostic test for the quantitative determination of transferrin in human serum, heparinized plasma or EDTA plasma on the Dimension Vista® System. Measurements of transferrin aid in the diagnosis of malnutrition, acute inflammation, infection, and iron deficiency anemia.

Dimension Vista " Protein 1 Calibrator: PROT1 CAL is an in vitro diagnostic product for the calibration of the C3 complement (C3), C4 complement (C4), Immunoglobulin A (IGA), Immunoglobulin G (IGG), Immunoglobulin M (IGM), Prealbumin (PREALB) and Transferrin (TRF) methods on the Dimension Vista® System.

Dimension Vista™ Protein 1 Control L, M and H: PROT1 CON L, M and H are assayed intralaboratory quality controls for assessment of precision and analytical bias in the determination of C3 Complement (C3), C4 Complement (C4), immunoglobulin A (IGA), immunoglobulin G (IGG), immunoglobulin M (IGM), prealbumin (PREALB) and transferrin (TRF) on the Dimension Vista "System.

Dimension Vista™ TRF Flex® reagent cartridge: 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" Protein 1 Calibrator: Protein 1 Calibrator is a multi-analyte, liquid, human serum based product containing C3 complement, C4 complement, immunoglobulin A (IGA), immunoglobulin G (IGG), immunoglobulin M (IGM), prealbumin (PREALB) and Transferrin.

Dimension Vista™ Protein 1 Control L, M and H: Protein 1 Control L, M and H are multi-analyte, liquid, human serum based products containing C3 complement, C4 complement, immunoglobulin A (IGA), immunoglobulin G (IGG), immunoglobulin M (IGM), prealbumin (PREALB) and transferrin.

This document describes the Dimension Vista™ TRF Flex® reagent cartridge, Dimension Vista™ Protein 1 Calibrator, and Dimension Vista™ Protein 1 Control L, M, and H, which are in vitro diagnostic medical devices. The core of your request focuses on the Dimension Vista™ TRF Flex® reagent cartridge for the quantitative determination of transferrin.

Here's an analysis of the provided information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the traditional sense of pre-defined thresholds. Instead, it presents a method comparison study comparing the new device (Dimension Vista™ TRF assay) with a legally marketed predicate device (Dade Behring N Antisera to Human Transferrin assay on the BN ProSpec® System). The reported device performance from this study serves as the evidence of equivalence to the predicate.

Note: The document states, "These studies demonstrate correlation and equivalent performance between the Dade Behring N Antisera to Human Transferrin assay and the Dimension Vista™ TRF assay." This implies that the observed correlation, slope, and intercept values were considered acceptable by the manufacturer for demonstrating substantial equivalence.

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

• Sample Size for Test Set: 180 samples (n = 180)
• Data Provenance: The document does not explicitly state the country of origin. It also does not explicitly state if the data was retrospective or prospective. However, given that it's a method comparison study for an in vitro diagnostic device, it is typically conducted on clinical samples, which are generally considered prospective or retrospective clinical samples collected for research purposes. No specific information on the demographics or collection methods is provided.

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

This type of in vitro diagnostic device (immunoassay for transferrin) does not typically involve human experts for establishing "ground truth" in the same way an imaging or pathology device would. The "ground truth" for method comparison studies like this is the measurement obtained from the predicate device (Dade Behring N Antisera to Human Transferrin assay on the BN ProSpec® System), which is itself an established laboratory method. Therefore, no human experts were involved in establishing the ground truth for this test set; rather, it relied on the analytical performance of a reference method.

4. Adjudication Method for the Test Set

Not applicable. As explained above, the "ground truth" for this method comparison study is the measurement obtained from the predicate device, not an interpretation requiring expert adjudication.

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

No. This is an in vitro diagnostic assay, not an imaging or interpretive device that would involve multiple human readers. Therefore, an MRMC comparative effectiveness study is not relevant here.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, in a sense. The study directly compares the analytical performance of the new automated Dimension Vista™ TRF assay (device only) against the predicate automated assay (device only). This is an evaluation of the algorithm/device's performance in generating quantitative results without human interpretive input affecting the result itself. The device is designed to provide a quantitative measurement.

7. Type of Ground Truth Used

The "ground truth" for the performance comparison was the measurements obtained from the legally marketed predicate device, the Dade Behring N Antisera to Human Transferrin assay on the BN ProSpec® System. This is a common approach for demonstrating substantial equivalence for new in vitro diagnostic assays.

8. Sample Size for the Training Set

The document does not provide information about a separate "training set." For in vitro diagnostic assays, especially those based on established immunochemical principles, the development often relies on well-understood chemical reactions and calibration procedures rather than a large, continuously-trained machine learning model in the typical sense. Data used for initial assay development and optimization would precede this validation study, but specifics are not mentioned.

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

As with point 8, the document does not detail a "training set" or its ground truth establishment. Development of such assays generally involves using characterized reference materials and calibrators, often with values traceable to international standards or established reference methods, to ensure accuracy during the assay's development and optimization phases.

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Dimension Vista® HCYS Flex® reagent cartridge: The HCYS method is an in vitro diagnostic test for the quantitative determination of total homocysteine in human serum, heparinized and EDTA plasma on the Dimension Vista® System. Measurements of homocysteine aid in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.

Dimension Vista® Protein 1 Calibrator: PROT 1 CAL is an in vitro diagnostic product for the calibration of the C3 complement (C3), C4 complement (C4), Homocysteine (HCYS), Immunoalobulin A (IGA). Immunoalobulin G (IGG), Immunoglobulin M (IGM), and Prealbumin / Transthyretin (PREALB) methods on the Dimension Vista® System.

Dimension Vista® Protein 1 Control L, M and H: PROT1 CON L. M and H are assayed intralaboratory quality controls for assessment of precision and analytical bias in the determination of C3 Complement (C3), C4 Complement (C4), Homocysteine (HCYS), Immunoglobulin A (IGA), Immunoglobulin G (IGG), Immunoglobulin M (IGM) and Prealbumin / Transthyretin (PREALB) on the Dimension Vista®.

Dimension Vista® HCYS Flex® reagent cartridge: Bound homocysteine in the sample is reduced to free homocysteine by the action of dithiothreitol, and then converted enzymatically to S-adenosyl-homocysteine (SAH). Conjugated S-adenosylcysteine (SAC), added at the onset of the reaction, competes with the SAH in the sample for bonding by anti-SAH antibodies bound to polystyrene particles. In the presence of SAH, there is either no aggregation or a weak aggregation of particles. In the absence of SAH in the sample, an aggregation of the polystyrene particles by the conjugated SAC occurs. The higher the SAH content of the reaction mixture, the smaller the scattered light signal. The result is evaluated by comparison with a standard of known concentration.

Dimension Vista® Protein 1 Calibrator: Protein 1 Calibrator is a multi-analyte, liquid, human serum based product containing C3, C4. Homocysteine (HCYS). Immunoalobulin A (IGA). Immunoalobulin G (IGG), Immunoglobulin M (IGM), and Prealbumin / Transthyretin (PREALB).

Dimension Vista® Protein 1 Control L, M and H: Protein 1 Control L. M and H are multi-analyte, liguid, human serum based products containing C3, C4, Homocysteine (HCYS), Immunoglobulin A (IGA), Immunoglobulin G (IGG), Immunoglobulin M (IGM), and Prealbumin / Transthyretin (PREALB).

The provided text describes a 510(k) summary for new in-vitro diagnostic products: the Dimension Vista® HCYS Flex® reagent cartridge, Dimension Vista® Protein 1 Calibrator, and Dimension Vista® Protein 1 Control L, M and H. The primary focus of the performance data in the submission is for the Dimension Vista® HCYS assay.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state acceptance criteria in the form of numerical thresholds or targets for the method comparison study. Instead, it relies on demonstrating correlation and equivalent performance to a legally marketed predicate device.

The reported device performance in the method comparison study showed:

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

• Sample Size: 215 serum and plasma samples.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective). However, it's implied to be laboratory-based testing of patient samples.

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

This type of information is generally not applicable to a submission for an in-vitro diagnostic assay like the Dimension Vista® HCYS. The "ground truth" for these types of assays is typically established by measurements from a reference method or a legally marketed predicate device, rather than by expert consensus on image interpretation or clinical diagnosis.

4. Adjudication Method for the Test Set

Not applicable. The study is a method comparison between two quantitative assays, not an adjudicated diagnostic study.

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 submission is for an in-vitro diagnostic reagent and calibrator/controls, not an AI-assisted diagnostic tool that would involve human readers.

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

Yes, a form of standalone performance was done for the Dimension Vista® HCYS assay. The study directly compared the new device's measurements (algorithm only in the context of the instrument) against the predicate device's measurements, without human interpretation of the results from either system.

7. The Type of Ground Truth Used

The ground truth was established by comparison to a legally marketed predicate device: the Dade Behring N Latex HCY assay on the BN ProSpec® System. This is a common approach for demonstrating substantial equivalence for new in-vitro diagnostic devices.

8. The Sample Size for the Training Set

The document does not mention a separate "training set" in the context of machine learning or AI. For an in-vitro diagnostic assay, the "training" (e.g., optimization and validation of the assay's reagents and methodologies) would occur internally during product development, prior to the submission of performance data. The reported "215" samples are for the method comparison study, which serves as a validation/test set.

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

As no explicit "training set" in the AI/ML context is mentioned, this question is not directly applicable. For the development of the assay, calibration and reference materials would have been used, with their values likely established through robust analytical methods and traceability to higher-order reference materials or methods.

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Dimension Vista™ C3 Flex® reagent cartridge: The C3 method is an in vitro diagnostic test for the quantitative measurement of complement C3 in human serum and heparinized plasma on the Dimension Vista™ System. Measurements of C3 are used as an aid in the diagnosis of immunologic disorders associated with complement C3 protein.

Dimension Vista™ C4 Flex® reagent cartridge: The C4 method is an in vitro diagnostic test for the quantitative measurement of complement C4 in human serum and heparinized plasma on the Dimension Vista™ System. Measurements of C4 are used as an aid in the diagnosis of immunologic disorders associated with complement C4 protein.

Dimension Vista™ Protein 1 Calibrator: Protein 1 Calibrator is an in vitro diagnostic product for the calibration of the C3 Complement (C3), C4 Complement (C4), Immunoglobulin A (IGA), Immunoglobulin G (IGG), and Immunoglobulin M (IGM) on the Dimension Vista™ System.

Dimension Vista™ Protein 1 Control L, Dimension Vista™ Protein 1 Control M and Dimension Vista™ Protein 1 Control H: Protein 1 Control L/M/H are for use as an assayed intralaboratory quality controls for the assessment of precision and analytical bias in determination of C3 Complement (C3), C4 Complement (C4), Immunoglobulin A (IGA), Immunoglobulin G (IGG) and Immunoglobulin M (IGM) methods on the Dimension Vista™ System.

Dimension Vista™ C3 and C4 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 calibrator of known concentration.

Dimension Vista™ Protein 1 Calibrator: Protein 1 Calibrator is a multi-analyte, liquid human serum based product containing, C3 Complement, C4 Complement, Immunoglobulin A, Immunoglobulin G and lmmunoqlobulin M (IGM).

Dimension Vista™ Protein 1 Controls L/M/H: Protein 1 Controls L/M/H are multi-analyte, liquid human serum based products containing C3 Complement, C4 Complement, Immunoglobulin A, Immunoglobulin G and lmmunoglobulin M (IGM).

This 510(k) summary describes a new in vitro diagnostic (IVD) device, the Dimension Vista™ C3 and C4 Flex® reagent cartridges, along with associated calibrators and controls. The device is intended for the quantitative measurement of complement C3 and C4 in human serum and heparinized plasma on the Dimension Vista™ System, to aid in the diagnosis of immunologic disorders.

The document focuses on demonstrating substantial equivalence to a legally marketed predicate device (Dade Behring N Antisera to Human Complement Factors (C3c, C4) assays). However, it does not contain the specific information required to complete most sections of your request. This is common for 510(k) summaries of IVDs like reagent cartridges, which rely on analytical performance parameters (e.g., accuracy, precision, linearity, interference) rather than clinical studies with human readers or ground truth established by experts in the same way an imaging AI device would.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

The provided text only briefly mentions that the "result is evaluated by comparison with a calibrator of known concentration" and that the device is "substantially equivalent" to the predicate. It does not provide explicit acceptance criteria (e.g., specific thresholds for coefficient of variation, bias, or correlation with a reference method) or a table of performance data against those criteria. This type of detailed analytical performance data would typically be found in the full 510(k) submission, not in the summary or clearance letter.

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

The document does not specify test set sample sizes or data provenance (e.g., country of origin, retrospective/prospective). For IVD devices like this, the "test set" would typically refer to a panel of patient samples used to evaluate various analytical performance characteristics.

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

This information is not applicable to this type of IVD device. Ground truth for an assay measuring C3/C4 levels would be established by reference methods or gravimetric preparations, not by expert review of patient cases.

4. Adjudication method for the test set

This information is not applicable to this type of IVD device.

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

No such study was mentioned or would typically be relevant for a diagnostic assay measuring a biomarker. MRMC studies are primarily used for imaging AI devices that assist human interpretation.

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

The device is an automated in vitro diagnostic test. Its "standalone" performance is its performance, as it quantifies complement levels automatically. However, the document does not present the specific standalone performance metrics.

7. The type of ground truth used

For an IVD measuring complement C3 and C4, the "ground truth" for evaluating its analytical performance would be established through:

• Reference Methods: Comparison against established, highly accurate laboratory methods for measuring C3 and C4.
• Certified Reference Materials/Calibrators: Using materials with known, accurately assigned concentrations of C3 and C4.
• Gravimetric/Volumetric Preparation: For controls and calibrators, the known concentrations are established by precise preparation.

The provided document mentions the Dimension Vista™ Protein 1 Calibrator and Controls, which are used to establish and monitor the assay's performance against known concentrations.

8. The sample size for the training set

This information is not applicable. This device is a reagent cartridge and an instrument system, not a machine learning model that requires a "training set" in the conventional AI sense. Its performance is based on the underlying chemical reactions and optical detection, not on learning from a dataset.

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

Not applicable, as there is no "training set" in the context of this IVD device.

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