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Dimension Vista™ CRP Flex® reagent cartridge: The CRP method is an in vitro diagnostic test for the quantitative measurement of C-reactive protein (CRP) in human serum and heparinized plasma by means of particle enhanced immunonephelometry on the Dimension Vista™ System. In acute phase response, increased levels of a number of plasma proteins, including C-reactive protein, are observed. Measurement of CRP is useful for the detection and evaluation of infection, tissue injury, and inflammatory disorders.

Dimension Vista™ Protein 2 Calibrator: Protein 2 Calibrator is an in vitro diagnostic product for the calibration of the C-reactive protein (CRP) method on the Dimension Vista ™ System.

Dimension Vista™ Protein 2 Control L and H: Protein 2 Control L and H are for use as assayed intralaboratory quality controls for the assessment of precision and analytical bias in determination of C-reactive protein (CRP) on the Dimension Vista™ System.

Dimension Vista™ CRP Flex® reagent cartridge: Polystyrene particles coated with monoclonal antibodies specific to human CRP are aggregated when mixed with samples containing CRP. 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: Protein 2 Calibrator is a liquid human serum based product containing C-reactive protein (CRP).

Dimension Vista™ Protein 2 Control L and H: Protein 2 Control L and H are liquid human serum based products containing C-reactive protein (CRP).

The provided text describes the 510(k) summary for the Dimension Vista™ CRP Flex® reagent cartridge, Dimension Vista™ Protein 2 Calibrator, and Dimension Vista™ Protein 2 Control L and H. It details the device's performance characteristics through a method comparison study.

Here's an analysis of the acceptance criteria and study as requested, based on the provided input:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" for the method comparison study in a formalized table. However, the performance is reported through regression analysis, a common method to assess agreement between two assays. The key performance indicator provided is the correlation coefficient. While no specific threshold is given as an "acceptance criterion" within the text, correlation coefficients close to 1 are generally indicative of good agreement.

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

• Sample Size: 140 serum and plasma samples were used in the method comparison study.
• Data Provenance: The document does not specify the country of origin of the data. It also does not explicitly state if the study was retrospective or prospective. Given that samples with concentrations ranging from 3.36 to 182.76 mg/L were evaluated, it is likely that existing clinical samples were used, which would suggest a retrospective or observational nature of sample collection for this comparison study.

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

This information is not provided in the document. The "ground truth" in this context is the reference measurement from the predicate device (Dade Behring CardioPhase® hsCRP assay on the BN ProSpec® System). The document describes a comparison between two methods of analytical measurement. It does not involve expert interpretation of results to establish a "ground truth" for diagnostic purposes in the way a clinical study with radiologists or other specialists might.

4. Adjudication Method for the Test Set:

This information is not applicable and therefore not provided. Adjudication methods (e.g., 2+1, 3+1) are typically used in studies where human readers or experts interpret results and disagreements need to be resolved. This study is a direct analytical method comparison between two in vitro diagnostic assays.

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

No, a MRMC comparative effectiveness study was not done. This study focuses on the analytical performance comparison between a new in vitro diagnostic (IVD) assay and a predicate IVD assay, not on the impact of the assay on human reader performance or diagnostic effectiveness by human readers.

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

Yes, the study is essentially a standalone (algorithm only) performance assessment. The Dimension Vista™ CRP assay is an automated in vitro diagnostic test. The method comparison described assesses the device's ability to quantitatively measure CRP levels independently and compares these measurements to those obtained from a predicate device. There is no human interpretation "in the loop" for the measurement itself, only for the subsequent clinical use of the results.

7. The Type of Ground Truth Used:

The "ground truth" in this analytical comparison study is the measurements obtained from the legally marketed predicate device, the Dade Behring CardioPhase® hsCRP assay run on the BN ProSpec® System. This is considered the reference method for comparison.

8. The Sample Size for the Training Set:

The document does not provide information about a separate "training set" for the Dimension Vista™ CRP assay. IVD devices like this are typically developed and validated using a variety of studies (e.g., linearity, precision, interference, method comparison). While development data would have been used during the assay's creation, the provided text describes a specific "method comparison study" which serves as part of the validation/test phase for regulatory submission.

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

As no specific "training set" is described for this regulatory submission (which focuses on validation), information on how its ground truth was established is not provided. If an internal training set was used during product development, its ground truth would likely have been established using reference methods similar to how the predicate device served as the "ground truth" for this method comparison.

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