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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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