Search Results

The Access Rubella IgG assay is a paramagnetic-particle, chemiluminescent immunoassay for the qualitative and quantitative determination of IgG antibodies to the rubella virus in human serum using the using the Access Immunoassay Systems. The Access Rubella IgG assay aids in the diagnosis of rubella infection and the determination of immunity.

The Access Rubella IgG reagents consist of reagent packs, calibrators, QC, substrate and wash buffer.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Access® Rubella IgG Assay:

Acceptance Criteria and Device Performance:

Study Details:

1. Sample sizes used for the test set and the data provenance: Not explicitly stated. The document mentions "clinical data" but does not specify the number of samples or their country of origin (retrospective or prospective).

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for this type of device. The ground truth for this immunoassay device is typically established through a combination of reference methods (e.g., CDC reference assays), serology algorithms, and potentially clinical correlation, rather than expert consensus on images or clinical cases. The document does not provide details on how the ground truth for the "clinical data" used in the method comparison was established.

3. Adjudication method for the test set: Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for qualitative assessments, often in image interpretation, where human readers might disagree. This device is an immunoassay, and its performance is evaluated quantitatively (reproducibility, linearity, correlation).

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: Not applicable. This is an immunoassay device, not an AI-assisted diagnostic tool that aids human readers. Therefore, an MRMC study and effects on human reader performance are not relevant.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Yes, the described studies (reproducibility, concordance, linearity, method comparison) evaluate the standalone performance of the Access Rubella IgG assay on the Dxl System. The device provides a quantitative result (IgG antibody levels) or a qualitative determination (positive/negative) without human interpretation of raw data in the same way an imaging AI algorithm might be interpreted.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The specific ground truth for the "clinical data" used in the method comparison study is not explicitly detailed. For an immunoassay like this, ground truth for rubella infection and immunity typically relies on established serological reference methods, clinical history, and potentially a combination of IgM and IgG results, rather than pathology or expert consensus on clinical presentation alone. The predicate device (Access 2 System) is implicitly considered a reference standard for the purpose of demonstrating substantial equivalence.

7. The sample size for the training set: Not applicable. This device is an immunoassay system, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. The "training" for such a system involves the development and optimization of reagents and protocols, which is a different process than training an AI model.

8. How the ground truth for the training set was established: Not applicable, as there is no "training set" in the AI/ML context for this device.

Ask a specific question about this device