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510(k) Data Aggregation
(38 days)
The Diamedix Is anti-Gliadin IgG Test Kit is an indirect enzyme immunoassay (EIA) for the semi-quantitative measurement of IgG antibodies to gliadin in human serum as an aid in the diagnosis of celiac disease. These reagents can be used either manually or in conjunction with the MAGO® Plus Automated EIA Processor.
The Is-anti-Gliadin IgG Test System is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative measurement of IgG antibodies to gliadin in human serum.
Here's an analysis of the provided 510(k) summary, extracting the requested information about acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary does not explicitly state pre-defined "acceptance criteria" in a quantitative format (e.g., "sensitivity must be >X%"). Instead, it presents performance characteristics and implies that these results are deemed acceptable for substantial equivalence to the predicate device and for the intended use.
Based on the provided data, we can infer the following performance metrics:
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Relative Sensitivity (vs. other EIA) | Should be comparable to or better than predicate device. (No explicit threshold stated.) | 87.5% (95% CI: 79.2-93.4%) |
| Relative Specificity (vs. other EIA) | Should be comparable to or better than predicate device. (No explicit threshold stated.) | 100.0% (95% CI: 95.8-100.0%) |
| Overall Agreement (vs. other EIA) | Should be comparable to or better than predicate device. (No explicit threshold stated.) | 93.4% (95% CI: 88.8-96.6%) |
| Clinical Specificity (Normals) | High specificity in healthy population. (No explicit threshold stated.) | 97.1% (203/209) |
| Clinical Specificity (Other Diseases) | High specificity in other disease populations to minimize cross-reactivity. (No explicit threshold stated.) | 96.2% (128/133) |
| Clinical Sensitivity (Possible Celiac Disease) | High sensitivity in suspected celiac disease. (No explicit threshold stated.) | 94.4% (68/72) |
| Clinical Sensitivity (Diagnosed Celiac Disease) | High sensitivity in confirmed celiac disease. (No explicit threshold stated.) | 75.0% (42/56) |
| Correlation (Manual vs. Automated) | Strong positive correlation (e.g., r > 0.9). | Correlation Coefficient (r) = 0.9577 |
| Precision (Intra-assay & Interassay) | Low variability (e.g., CV% < 20% typically for ELISA). No explicit thresholds stated. | Manual (CV%): Max Intra-assay CV% ~8.99%, Max Interassay CV% ~13.41% MAGO Plus (CV%): Max Intra-assay CV% ~18.81%, Max Interassay CV% ~14.19% |
| Minimum Detection Limit | Clearly defined and acceptable for clinical use. | 3.0 U/ml |
| Prevalence in Normal Population | Low incidence in healthy population. | 3.4% positive in S. Florida blood donors (148 total). |
2. Sample Size Used for the Test Set and Data Provenance
- Relative Sensitivity and Specificity Study (Section A):
- Sample Size: 190 frozen retrospective sera.
- Data Provenance: Not explicitly stated (e.g., country of origin), but described as "normal samples, clinical samples submitted to a large reference laboratory for celiac disease evaluation." Contains samples from pediatric patients.
- Clinical Sensitivity and Specificity Study (Section B):
- Sample Size: 484 frozen retrospective, clinically characterized sera.
- Data Provenance: Not explicitly stated (e.g., country of origin). Sera were from "normal sera," "patients with possible celiac disease," "patients with diagnosed celiac disease," and various other autoimmune/gastrointestinal diseases.
- Manual and MAGO Plus Correlation Study (Section C):
- Sample Size: 174 serum samples.
- Data Provenance: Not specified.
- Precision Study (Section D):
- Sample Size: 6 serum samples, each tested in triplicate in 3 separate runs (total of 9 measurements per sample for inter-assay).
- Data Provenance: Not specified.
- Expected Values Study (Normal Population) (Section D, TABLE 5):
- Sample Size: 148 S. Florida blood donors.
- Data Provenance: Prospective (implied, as they were "blood donors") from South Florida, USA.
- Expected Values Study (Clinical Population) (Section D):
- Sample Size: 61 sera from patients with diagnosed celiac disease.
- Data Provenance: Not specified, likely retrospective from a clinical setting.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document does not mention the use of experts to establish ground truth for the test set samples themselves.
- For the "Relative Sensitivity and Specificity" study, the comparison is made against "a commercially available ELISA kit for detecting gliadin IgG antibodies" and a "referee EIA method" for discordant samples. The "ground truth" for this study is the result obtained from these other assays.
- For the "Clinical Sensitivity and Specificity" study, sera are described as "clinically characterized" or from "patients with diagnosed celiac disease." This implies that the ground truth was established through broader clinical diagnosis, which would typically involve a multidisciplinary approach by medical professionals (e.g., gastroenterologists, pathologists), but the number and specific qualifications of these experts are not detailed within this summary.
4. Adjudication Method for the Test Set
No formal adjudication method (like 2+1 or 3+1 consensus) for establishing ground truth is explicitly described for any of the studies.
- In the "Relative Sensitivity and Specificity" study, discordant samples between the investigational device and the initial comparator EIA were "further resolved" by a "referee EIA method." This implies a form of tie-breaking or verification rather than a formal expert adjudication of all cases.
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 performed. This device is an in-vitro diagnostic (IVD) ELISA test system, not an imaging device or a system requiring human interpretation comparison with and without AI assistance. The performance evaluation focuses on the assay's ability to detect antibodies, not on reader performance improvements.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the studies are inherently "standalone" in the sense that they evaluate the performance of the device (the assay kit, with both manual and automated processing options) directly. The device itself is not an "AI algorithm" in the modern sense but an ELISA kit. The "performance characteristics" sections (Relative Sensitivity/Specificity, Clinical Sensitivity/Specificity, Precision) directly assess the output of the assay (antibody levels) against comparator methods or clinical diagnoses.
7. The Type of Ground Truth Used
The types of "ground truth" used vary across the studies:
- Relative Sensitivity and Specificity: Results from a "commercially available ELISA kit" and a "referee EIA method."
- Clinical Sensitivity and Specificity: "Clinically characterized sera" and "sera from patients with diagnosed celiac disease." This suggests a combination of clinical diagnosis, patient history, and possibly other diagnostic tests (e.g., endoscopy, biopsy, genetic testing for celiac disease diagnosis), rather than a single direct pathology outcome for every case. However, the specific diagnostic methods for characterization are not detailed.
- Expected Values (Normal Population): Blood donor status and clinical absence of symptoms/disease for the normal population.
- Expected Values (Clinical Population): Diagnosis of celiac disease.
8. The Sample Size for the Training Set
The document does not mention a "training set." This type of IVD device is an immunoassay kit, not an AI/machine learning model that typically requires a large training dataset. The studies described are performance validation studies for the device itself.
9. How the Ground Truth for the Training Set was Established
As no training set is mentioned or applicable for this type of device, this question is not relevant.
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