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510(k) Data Aggregation
(142 days)
EA-D IGM ELISA TEST SYSTEM
For the qualitative determination of IgM antibodies in human serum to Epstein Barr (recombinant) early antigen diffuse (EA-D) antigen. The & EA-D IgM assay should be used in conjunction with other Epstein-Barr serologies (VCA IgM, VCA IgG, EBNA-1 IgG, EBNA-1 IgM, EA-D IgG and heterophile) as an aid in the diagnosis of infectious mononucleosis. The test can be performed either manually or in conjunction with the MAGO PLUS The Automated EIA Processor.
The & EA-D IgM ELISA Kit is an enzyme-linked immunosorbent assay (ELISA) for the detection of IgM antibodies to Epstein-Barr Early antigen diffuse in human serum.
Here's an analysis of the provided text regarding the acceptance criteria and study for the EA-D IgM ELISA Kit:
The document does not explicitly state pre-defined acceptance criteria for the device's performance. Instead, it presents the results of its performance characteristics study. The acceptance for market clearance seems to be based on "substantial equivalence" to legally marketed predicate devices, implying that the observed performance falls within an acceptable range compared to those predicates, even if specific numerical targets aren't listed here.
However, we can infer the "reported device performance" from the study results.
1. A table of acceptance criteria and the reported device performance
As stated, explicit acceptance criteria are not presented in the document. The table below outlines the reported performance from the study, which would have been evaluated against a benchmark for substantial equivalence.
| Performance Metric | Reported Device Performance | Comments |
|---|---|---|
| Clinical Performance (vs. Serological Status) | ||
| Relative Specificity (Convalescent) | 94.9% (95% CI: 88.5-98.3%) | Based on 93/98 sera |
| Relative Sensitivity (Current Infection) | 45.9% (95% CI: 29.5-63.1%) | Based on 17/37 sera |
| Relative Specificity (Seronegative) | 96.7% (95% CI: 82.8-99.9%) | Based on 29/30 sera |
| Overall Agreement | 84.2% (95% CI: 78.7-89.8%) | Based on 139/165 sera (equivocal excluded) |
| Precision (Internal Site #1) | Coefficient of Variation (CV%) | |
| Intra-Assay CV% (Positive samples) | 4.53% - 12.81% | Range across 4 positive sera and 3 runs |
| Intra-Assay CV% (Negative samples) | 35.23% - 46.08% | Range across 2 negative sera and 3 runs |
| Inter-Assay CV% (Positive samples) | 5.35% - 11.20% | Range across 4 positive sera |
| Inter-Assay CV% (Negative samples) | 34.16% - 42.74% | Range across 2 negative sera |
| Inter-Site Precision | Coefficient of Variation (CV%) | |
| Inter-Site CV% (Positive samples) | 9.10% - 17.32% | Range across 4 positive sera (n=90) |
| Inter-Site CV% (Negative samples) | 30.28% - 31.41% | Range across 2 negative sera (n=90) |
| Correlation (Manual vs. MAGO Plus) | ||
| Pearson's Correlation Coefficient | 0.975 | Between manual and MAGO Plus results (128 samples) |
| Specificity (Cross-Reactivity) | Some expected | Non-reactive for anti-EA-D IgM in VZV, CMV, HSV positive sera; suggests some cross-reactivity may occur with these analytes. |
| MAGO Plus Precision (Site #2) | Coefficient of Variation (CV%) | |
| Intra-Assay CV% (Positive samples) | 3.76% - 16.10% | Range across 4 positive sera and 3 runs |
| Intra-Assay CV% (Negative samples) | 0.00% - 37.16% | Range across 2 negative sera and 3 runs |
| Inter-Assay CV% (Positive samples) | 4.35% - 11.76% | Range across 4 positive sera |
| Inter-Assay CV% (Negative samples) | 20.86% - 30.51% | Range across 2 negative sera |
2. Sample sized used for the test set and the data provenance
- Test Set Sample Size: 176 patient sera were used for the clinical performance study.
- Data Provenance: The data used was from retrospective sera from patients. The country of origin is not explicitly stated, but given the applicant and reporting of a 510(k) to the FDA, it is highly likely to be from the USA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The ground truth for the test set was established by characterizing the 176 frozen retrospective sera using "commercially available kits for VCA IgM, VCA IgG, EBNA IgG and heterophile antibodies."
- Number of Experts: Not applicable, as the "ground truth" (or reference standard) was established using other commercial serological assays, not by expert interpretation.
- Qualifications of Experts: Not applicable.
4. Adjudication method for the test set
The concept of an "adjudication method" as typically applied in scenarios involving multiple human readers (e.g., 2+1, 3+1 for discrepancies) is not relevant here. The ground truth for the test set was determined by the results of other commercial serological assays, which are considered objective measurements, not subjective interpretations requiring adjudication.
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
- MRMC Study Done: No, an MRMC comparative effectiveness study was not done.
- Effect Size of Human Readers Improvement with/without AI: Not applicable, as this is an in vitro diagnostic device for antibody detection, not an imaging analysis or interpretive AI system that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the primary clinical performance study (Section A) evaluates the device in standalone mode. The results of the Is-EBV-EA-D IgM Test Kit were directly compared to the classification of patient sera based on other commercial EBV serologies. While a technician performs the test, the result (positive, negative, equivocal) is generated by the kit itself, making it a standalone assessment of the device's diagnostic capability. The section on manual vs. MAGO Plus correlation also demonstrates standalone performance for both methods.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for the clinical performance study was established using a combination of commercially available serological assays for Epstein-Barr Virus (EBV) antibodies. This allowed for the classification of sera into "convalescent," "current infection," and "seronegative" categories based on established serological patterns for EBV infection. It's a form of clinical reference standard based on established serology.
- Specifically:
- Convalescent (past infection): Positive for VCA IgG and/or EBNA IgG antibodies; negative for VCA IgM and heterophile antibody.
- Seronegative: Negative for VCA IgG, VCA IgM, EBNA IgG, and heterophile antibody.
- Current (recent) infection: Positive for VCA IgM and/or heterophile antibody; negative for EBNA IgG.
8. The sample size for the training set
The document does not explicitly describe a separate "training set" for the development of the EA-D IgM ELISA Kit. The provided studies focus on the performance evaluation of the developed device. For in vitro diagnostic kits, the "training" (development and optimization) phase is usually internal and not detailed in 510(k) summaries in the same way as machine learning models. Therefore, the sample size for a training set (in the ML sense) is not reported.
9. How the ground truth for the training set was established
As there is no distinct "training set" described in the context of machine learning model development, the method for establishing its ground truth is not applicable/not reported in this 510(k) summary. The development of an ELISA kit involves biochemical optimization and formulation, rather than algorithmic training on labeled data in the way an AI/ML model would.
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