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Dimension Vista™ RF Flex® reagent cartridge: The RF method is an in vitro diagnostic reagent for the quantitative determination of rheumatoid factors (RF) in human serum and lithium heparin plasma on the Dimension Vista™ System. Measurements of RF are used as an aid in the diagnosis of rheumatoid arthritis.

Dimension Vista™ Protein 2 Calibrator: PROT2 CAL is an in vitro diagnostic product for the calibration of the C-reactive protein (CRP), high sensitivity CRP (hsCRP) and Rheumatoid Factors (RF) methods on the Dimension Vista™ System.

Dimension Vista™ Protein 2 Controls L and H: PROT2 CON L and H are assayed intralaboratory quality controls for the assessment of precision and analytical bias in the determination of C-reactive protein (CRP) and Rheumatoid Factors (RF) on the Dimension Vista™ System.

Dimension Vista™ RF Flex® reagent cartridge: Polystyrene particles coated with an immunocomplex consisting of human immunoglobulin and anti-human IgG from sheep are aggregated when mixed with samples containing RF. These aggregates 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 2 Calibrator: PROT2 CAL is a liquid, human serum based product containing C-reactive protein and Rheumatoid Factors.

Dimension Vista™ Protein 2 Control L and H: PROT2 CON L and H are liquid, multi-analyte, human serum based products containing C-reactive protein and Rheumatoid Factors.

Here's an analysis of the provided text regarding the Dimension Vista™ RF Flex® reagent cartridge and its associated calibrator and controls:

Acceptance Criteria and Device Performance

The acceptance criteria for the Dimension Vista™ RF assay are implied by its comparison to a legally marketed predicate device (ROCHE Tina-Quant RF II assay). The study aims to demonstrate substantial equivalence, meaning the new device performs similarly to the established one.

1. Table of Acceptance Criteria and Reported Device Performance:

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сенерге советские повенности податистери" (Note: The regression equation and the "Correlatio" section are unfortunately garbled in the provided text. To properly assess the performance, the actual numerical values for slope, intercept, and correlation coefficient would be required. However, the text indicates that a regression analysis was performed on samples ranging from 10 to 520 IU/ML.) |
| Intended Use Equivalence | Quantitative determination of rheumatoid factors (RF) in human serum and lithium heparin plasma as an aid in the diagnosis of rheumatoid arthritis. | The Dimension Vista™ RF Flex® reagent cartridge has the same intended use: "in vitro diagnostic reagent for the quantitative determination of rheumatoid factors (RF) in human serum and lithium heparin plasma on the Dimension Vista™ System. Measurements of RF are used as an aid in the diagnosis of rheumatoid arthritis." |

Study Details:

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

• Sample Size for Test Set: The document states that the Dimension Vista™ RF assay was compared to the ROCHE Tina-Quant RF II assay "by evaluating serum samples with concentrations ranging from 10 to 520 IU/ML." The exact number of samples (N) is not explicitly stated in the provided text.
• Data Provenance: Not explicitly stated (e.g., country of origin). The study is retrospective in nature, as it involves comparing the new device against existing serum samples previously analyzed by the predicate device.

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

• This type of in vitro diagnostic device (IVDD) study (quantitative measurement of a biomarker) typically does not rely on human experts to establish "ground truth" for individual sample values. Instead, the "ground truth" for the test samples is established by the predicate device's measurement. The study measures the agreement between the new device and the predicate.
• Therefore, no experts were used to establish ground truth in the traditional sense (e.g., radiologists interpreting images). The "ground truth" is analytical, derived from the established method.

4. Adjudication method for the test set:

• None. Adjudication is typically used in clinical studies where expert disagreement on a diagnosis or finding needs to be resolved. For a quantitative IVDD comparison, the predicate device's result is taken as the reference.

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. This is not an MRMC study. MRMC studies are relevant for imaging diagnostics or other subjective interpretations where human readers are involved. This is a study comparing the analytical performance of two automated diagnostic assays.

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

• Yes, this is essentially a standalone performance study. The Dimension Vista™ RF assay is an automated diagnostic assay. Its performance is evaluated directly through its measurements on patient samples, without human intervention in the result generation or interpretation for the purpose of this comparison study. The comparison is between two automated systems.

7. The type of ground truth used:

• The ground truth for the samples used in the method comparison study was established by the predicate device, the ROCHE Tina-Quant RF II assay. This means the values obtained from the predicate device were considered the reference against which the Dimension Vista™ RF assay's results were compared.

8. The sample size for the training set:

• The document does not provide information on a specific "training set" sample size. As an analytical assay, the development may involve internal optimization and calibration processes, but a distinct "training set" in the context of machine learning or AI development is not detailed here. The focus for regulatory submission is on the validation against the predicate and performance characteristics.

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

• Since a "training set" is not explicitly mentioned or detailed in the provided text in the context of device development or performance, this information is not available. For analytical assays, internal development processes would typically involve using known concentration standards and reference materials to calibrate and optimize the assay's performance.

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