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The IgA method is an in vitro diagnostic test for the quantitative measurement of Immunoglobulin A in human serum and heparinized plasma on the Dimension Vista™ System. Measurements of IgA aid in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.

PROT1 CAL is an in vitro diagnostic product for the calibration of Immunoglobulin A (IGA) and Immunoglobulin G (IGG) methods on the Dimension Vista™ System.

For use as an assayed intralaboratory quality control for assessment of precision and analytical bias in the determination of Immunoglobulin A (IGA) and Immunoglobulin G (IGG) on the Dimension Vista™ System.

Dimension Vista™ IGA 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 calibrator of known concentration.

Dimension Vista™ Protein 1 Calibrator: Protein 1 Calibrator is a liquid, human serum based product containing Immunoglobulin A and Immunoqlobulin G.

Dimension Vista™ Protein 1 Controls L/M/H: Protein Controls L, M and H are multi-analyte, liquid human serum based product containing Immunoglobulin A and Immunoglobulin G.

Here's an analysis of the provided text regarding the Dimension Vista™ IGA Assay, focusing on acceptance criteria and the supporting study:

The provided text details a 510(k) summary for a new in vitro diagnostic device, the Dimension Vista™ IGA Flex® reagent cartridge, along with its associated calibrator and controls. It highlights the device's performance characteristics through a method comparison study.

Acceptance Criteria and Device Performance

The document does not explicitly state pre-defined "acceptance criteria" in a typical quantitative sense (e.g., minimum R-squared value, specific bias limits). Instead, it presents a "method comparison study" where the new device's performance is compared against a legally marketed predicate device. The implied acceptance is based on the regression analysis results demonstrating substantial equivalence.

Table of Acceptance Criteria (Implied) and Reported Device Performance

The strong correlation (R-value of 0.998) and a slope close to 1.0 with a small y-intercept suggest that the Dimension Vista™ IGA assay performs similarly to the predicate device.

Study Details for Device Performance

The study described is a method comparison study intended to demonstrate substantial equivalence to a legally marketed predicate device.

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

   • Sample Size: 100 samples (50 serum, 50 plasma).
   • Data Provenance: Not specified regarding country of origin or whether it's retrospective or prospective. It states "human serum and heparinized plasma," implying they are clinical samples. Without further information, it's impossible to determine retrospectivity or prospectivity.

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

   • This information is not provided in the document. For in vitro diagnostic assays measuring specific analytes like IgA, "ground truth" is typically established by the reference method or the established predicate device's measurement, rather than expert consensus on interpretation. The predicate device (Dade Behring N Antisera to Human IgA on the BN ProSpec System) served as the comparator, representing the established "truth" for this comparison.

3. Adjudication Method for the Test Set:

   • Not applicable as this is a quantitative measurement comparison study between two assays, not a subjective interpretation task requiring adjudication. The "truth" is derived from the predicate device's quantitative output.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No, an MRMC comparative effectiveness study was not conducted. This type of study is relevant for imaging or diagnostic interpretation tasks where human readers' performance is being evaluated, often with or without AI assistance. This document describes an in vitro diagnostic assay for quantitative measurement, which doesn't involve human 'readers' in an interpretive sense.

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

   • Yes, effectively. The study described is a standalone performance evaluation of the Dimension Vista™ IGA assay. It compares the analytical output of the new automated assay system (Dimension Vista™ IGA) directly against the output of the predicate automated assay system (N Antisera to Human IgA on the BN ProSpec System). There is no human interpretation or human-in-the-loop component being evaluated in this performance study itself; it's comparing two automated measurement systems.

6. The Type of Ground Truth Used:

   • The "ground truth" for this study was established by the measurement results from the legally marketed predicate device, the Dade Behring N Antisera to Human IgA assay run on the BN ProSpec System. This is a common practice for demonstrating substantial equivalence for in vitro diagnostic devices.

7. The Sample Size for the Training Set:

   • This information is not provided in the document. The document describes a comparison study, which is typically a validation or test set rather than a training set as understood in machine learning. For an IVD assay, it would involve assay development and optimization, which would use various samples but not explicitly "training sets" in the AI sense.

8. How the Ground Truth for the Training Set was Established:

   • This information is not provided as a "training set" is not explicitly mentioned or relevant in the context presented. The assay's development (optimization, reagent formulation, calibration) would have used reference materials and samples with known IgA concentrations, but these aren't typically termed a "training set" with established "ground truth" in the same way as for AI models.

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