Search Results
Found 1 results
510(k) Data Aggregation
(153 days)
The Eu-tTG® IgA is an in vitro diagnostic enzyme immunoassay for the semi-quantitative detection of IgA specific antibodies directed against tissue transglutaminase (tTG) in human serum. It is an aid in the diagnosis of celiac disease and should be used in conjunction with other serological tests and clinical findings.
The Eu-tTG® IgG is an in vitro diagnostic enzyme immunoassay for the semi-quantitative detection of IgG specific antibodies directed against tissue transglutaminase (tTG) in human serum. It is an aid in the diagnosis of celiac disease and should be used in conjunction with other serological tests and clinical findings.
Each test kit for Eu-tTG® IgA & Eu-tTG® IgG consists of one (1) microtiter plate (12 strips with 8 microwells coated with the human recombinant tTG antigen), assay controls (positive and negative), a ready-to-use set of five (5) calibrators, Horseradish Peroxidase (HRP) goat anti-human IgA or IgG conjugate, serum diluent, Tetramethylbenzidine (TMB) enzyme substrate, stop solution, and washing solution required for the assay.
The provided text describes two diagnostic devices, Eu-tTG® IgA and Eu-tTG® IgG, both intended as aids in the diagnosis of celiac disease. The study described focuses on their analytical and clinical performance.
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined acceptance criteria (e.g., "The device must achieve a sensitivity of at least X%"). Instead, it presents the results of method comparison and clinical studies, implying that the achieved performance was deemed sufficient for substantial equivalence to predicate devices. The comparator devices' performance would implicitly serve as a benchmark for acceptability.
However, based on the provided data, we can infer performance metrics. For this response, I will list the observed performance from the clinical studies as the "Reported Device Performance." Since no explicit "acceptance criteria" are given for these values, they serve as the performance characteristics that were reviewed for market clearance.
Eu-tTG® IgA
| Performance Metric | Reported Device Performance (with Borderline Samples Considered Positive, Cut-off 9 AU/mL) | Reported Device Performance (with Borderline Samples Considered Negative, Cut-off 16 AU/mL) |
|---|---|---|
| Sensitivity (95% C.I.) | 97.5% (92.9% - 99.5%) | 85.1% (77.5% - 90.9%) |
| Specificity (95% C.I.) | 98.3% (95.8% - 99.5%) | 99.2% (97.0% - 99.9%) |
| Positive Predictive Value (PPV) (95% C.I.) | 96.7% (91.8% - 99.1%) | 98.1% (93.3% - 99.8%) |
| Negative Predictive Value (NPV) (95% C.I.) | 98.8% (96.4% - 99.7%) | 93.0% (89.2% - 95.8%) |
Eu-tTG® IgG
| Performance Metric | Reported Device Performance (Cut-off 20 AU/mL) |
|---|---|
| Sensitivity (95% C.I.) | 57% (49% - 64.6%) |
| Specificity (95% C.I.) | 94.2% (90.5% - 96.8%) |
| Positive Predictive Value (PPV) (95% C.I.) | 87.0% (79.2% - 92.7%) |
| Negative Predictive Value (NPV) (95% C.I.) | 76.3% (71.0% - 81.0%) |
2. Sample Size Used for the Test Set and Data Provenance
- Eu-tTG® IgA Clinical Study Test Set: 363 clinical samples (121 positive celiac patients, 242 negative samples).
- Eu-tTG® IgG Clinical Study Test Set: 407 clinical samples (165 positive celiac patients, 242 negative samples).
- Data Provenance: The document does not explicitly state the country of origin. It indicates that samples were from "clinically diagnosed celiac positive" and "negative samples... from healthy blood donors, IBD patients, patients affected by food intolerances and patients with autoimmune or infectious diseases." This suggests the samples are retrospective, sourced from clinical settings or blood banks, and are clinical samples, not necessarily from a controlled prospective study for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document states that "The positive celiac patient samples were diagnosed with clinical findings and/or confirmed with biopsy." It does not specify the number of experts or their qualifications involved in establishing this ground truth (e.g., gastroenterologists, pathologists, etc.).
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for establishing the ground truth. It relies on existing clinical diagnoses and biopsy confirmations.
In the method comparison studies, the "comparator test" results served as the reference for agreement calculations, but this is not an adjudication of ground truth for the clinical diagnosis itself.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study focuses on the performance of a diagnostic immunoassay, not on human readers' interpretation of images or other data, with or without AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done
Yes, the studies presented are for the standalone performance of the Eu-tTG® IgA and Eu-tTG® IgG immunoassay kits. These are in vitro diagnostic devices that directly analyze human serum samples; they do not involve a human-in-the-loop for interpreting the assay's output to render a diagnosis. The results (AU/mL values) are generated solely by the device.
7. The Type of Ground Truth Used
The ground truth for the clinical studies was established by:
- Clinical findings: This implies a physician's assessment of symptoms, medical history, and other diagnostic indicators.
- Biopsy confirmation: This refers to histological examination of intestinal tissue, which is the gold standard for diagnosing celiac disease.
- For negative samples, the ground truth was based on being "healthy subjects and patients with autoimmune disorders, infectious disease and IBD" without celiac disease.
8. The Sample Size for the Training Set
The document does not specify a separate "training set" in the context of machine learning or AI development. These are immunoassay kits, which are typically developed and optimized through laboratory procedures, rather than being "trained" on data in the AI sense.
However, the "Assay Cut-off" section refers to testing "153 samples" (103 healthy subjects and 50 non-celiac controls) to establish the normal range and cut-off values. While not a "training set" in the AI sense, these samples were used to define parameters of the assay.
9. How the Ground Truth for the Training Set Was Established
As explained above, there isn't a "training set" in the typical AI sense. However, for the 153 samples used to establish cut-off values:
- Healthy subjects: Presumed to be healthy without celiac disease.
- Non-celiac controls (IBD patients): Diagnosed with IBD but implicitly confirmed not to have celiac disease.
The exact methods for establishing the "ground truth" (e.g., confirmation of health status, specific IBD diagnosis without co-occurring celiac disease) for these 153 samples are not detailed in the provided text.
Ask a specific question about this device
Page 1 of 1