(19 days)
The Access Toxo IgM II assay is a paramagnetic-particle, chemiluminescent immunoassay for the qualitative determination of Toxoplasma gondii-specific IgM antibody in adult human serum and plasma, using the Access Immunoassay Systems. The Access Toxo IgM II assay is presumptive for the diagnosis of acute, recent or reactivated Toxoplasma gondii infections in males and pregnant or non-pregnant females. It is recommended this assay be performed in conjunction with a Toxoplasma gondii-specific IgG antibody assay.
The Access Toxo IgM II reagents consist of reagent packs, controls, QC, substrate and wash buffer.
Here's a breakdown of the acceptance criteria and study information for the Access Toxo IgM II Assay, based on the provided document:
The document describes a modification to an existing device rather than a new device submission. The primary goal of the study was to demonstrate substantial equivalence of the modified device (Access Toxo IgM II assay on the UniCel DxI 800 Access Immunoassay System) to the legally marketed unmodified device (Access Toxo IgM II assay on the Access 2 System). Therefore, the "acceptance criteria" and "device performance" are focused on comparability between the two systems.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria in terms of sensitivity, specificity, or accuracy for the assay itself. Instead, the acceptance criteria are implicitly related to demonstrating substantial equivalence between the two instrument platforms (Access 2 vs. UniCel DxI 800) for the same assay.
| Acceptance Criteria Category | Specific Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Reproducibility | Assay results on the UniCel DxI 800 System should demonstrate consistent and repeatable measurements. | Met established acceptance criteria. |
| Concordance | Assay results from the UniCel DxI 800 System should agree with those from the Access 2 System. | Met established acceptance criteria. |
| Method Comparison | Strong statistical correlation between results from the UniCel DxI 800 System and the Access 2 System. | Showed good correlation between the DxI and Access 2 Systems. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample size used for the reproducibility and concordance studies. It also does not explicitly state the country of origin of the data or whether the study was retrospective or prospective.
- Sample Size: Not specified.
- Data Provenance: Not specified (country of origin, retrospective/prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This type of study (demonstrating equivalence between two instrument platforms for an immunoassay) typically does not involve human experts establishing a "ground truth" for individual test cases in the same way imaging or diagnostic algorithms might. The "ground truth" for comparability would be the results from the predicate device system (Access 2 System).
- Number of Experts: Not applicable for this type of comparison study.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
Since the "ground truth" is derived from the predicate device's results, there is no mention of an adjudication method involving multiple human readers.
- Adjudication Method: Not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. This study focuses on instrument equivalence for an immunoassay, not on human reader performance with or without AI assistance.
- Effect Size: Not applicable.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, in essence, this was a standalone performance study of the instrument platform running the assay. The focus was on the performance of the automated immunoassay system (UniCel DxI 800) itself, comparing its results to an established system (Access 2), without direct human interpretation influencing the raw assay results.
7. Type of Ground Truth Used
The "ground truth" in this context was the results obtained from the legally marketed predicate device (Access 2 Immunoassay System) using the same Access Toxo IgM II reagents. The study aimed to show that the new system produced equivalent results to the established system.
8. Sample Size for the Training Set
This document describes a validation study for a medical device's performance on a new instrument, not the development of a machine learning algorithm. Therefore, there is no "training set" in the context of AI/ML.
- Sample Size for Training Set: Not applicable.
9. How the Ground Truth for the Training Set Was Established
As there is no training set mentioned in the context of an AI/ML algorithm, this question is not applicable.
§ 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).