(24 days)
The Access Toxo IgG assay is a paramagnetic-particle, chemiluminescent immunoassay for the qualitative and quantitative determination of IgG antibodies to Toxoplasma gondii in human serum, using the Access Immunoassay Systems. The Access Toxo IgG assay aids in the diagnosis of Toxoplasma gondii infection and in the determination of protective levels of antibodies in pregnant women.
The Access Toxo 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 the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The provided text does not explicitly state numerical acceptance criteria for the studies. Instead, it makes a general statement about the device meeting established criteria.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Reproducibility | Met established acceptance criteria |
| Concordance | Demonstrated acceptable concordance |
| Linearity | Demonstrated acceptable linearity |
| Correlation (DxI vs. Access 2) | Demonstrated good correlation |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample size used for the test set. It mentions "concordance study data" for the method comparison, implying a test set was used, but the size is not specified. The provenance of the data (e.g., country of origin, retrospective or prospective) is also not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The study focuses on comparing two instrument platforms for an immunoassay, not on establishing a ground truth for diagnostic accuracy based on expert review.
4. Adjudication method for the test set
This information is not applicable and not provided. The study is a comparison between two laboratory instrument platforms, not an assessment requiring expert adjudication of cases.
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
An MRMC comparative effectiveness study was not done. This study is about the performance of an immunoassay on a new instrument platform, not about AI assistance for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not directly applicable. The "device" in question is an immunoassay system (hardware and reagents), not a standalone algorithm. The study assesses the performance of this system as a whole. Its performance is inherently "standalone" in the sense that the instrument processes the samples and delivers results without human interpretation within the assay measurement, but it's not an algorithm in the typical AI sense.
7. The type of ground truth used
The concept of "ground truth" as it typically applies to diagnostic accuracy (e.g., pathology, outcomes data) is not directly relevant here. The study aims to demonstrate substantial equivalence between two instrument platforms using the same assay. The "ground truth" for the comparison would be the results generated by the already cleared "Access 2" System, which the new "DxI 800" System is being compared against.
8. The sample size for the training set
This information is not provided because an AI/machine learning training set is not applicable to an immunoassay instrument and reagent system. This is a traditional laboratory diagnostic device.
9. How the ground truth for the training set was established
This information is not provided and is not applicable, as there is no "training set" in the context of this immunoassay system.
§ 866.3780
Toxoplasma gondii serological reagents.(a)
Identification. Toxoplasma gondii serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies toToxoplasma gondii in serum. Additionally, some of these reagents consist of antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identifyToxoplasma gondii from clinical specimens. The identification aids in the diagnosis of toxoplasmosis caused by the parasitic protozoanToxoplasma gondii and provides epidemiological information on this disease. Congenital toxoplasmosis is characterized by lesions of the central nervous system, which if undetected and untreated may lead to brain defects, blindness, and death of an unborn fetus. The disease is characterized in children by inflammation of the brain and spinal cord.(b)
Classification. Class II (performance standards).