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510(k) Data Aggregation
(85 days)
The Access Thyroglobulin Antibody II assay is a paramagnetic chemiluminescent immunoassay for the quantitative determination of thyroglobulin antibody levels in human serum and plasma using the Access Immunoassay Systems. The measurement of thyroid autoantibodies may aid in the diagnosis of Hashimoto's disease, nontoxic goiter, and Graves' disease.
The Access Thyroglobulin Antibody II reagents, Thyroglobulin Antibody II calibrators, and the Access Immunoassay analyzers comprise the Access lmmunoassay System for the quantitative determination of thyroglobulin antibody in human serum and plasma.
Here's a breakdown of the acceptance criteria and study information for the Access Thyroglobulin Antibody II for use on the Access Immunoassay Systems, as extracted from the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the "Summary of Studies" section, which describes the performance characteristics that were measured and deemed acceptable for demonstrating substantial equivalence. Exact numerical acceptance thresholds for each test (e.g., "imprecision must be less than X%") are not explicitly stated as distinct criteria, but the reported performance values are presented as evidence of meeting acceptable levels.
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Method Comparison | Strong correlation with predicate device | New = m(predicate)1.0 ± 0.12, R² ≥ 0.92 (for 397 samples, range <0.9 to 2500 IU/mL) |
| Imprecision | Low imprecision across various concentrations | Within-run: 3.6 to 5.7 %CVBetween-run: 0.0 to 5.2 %CVTotal: 4.8 to 7.7 %CV (at 26.9 to 1889.6 IU/mL).Overall: < 10% CV for ≥ 15 IU/mL; < 1.5 IU/mL SD for < 15 IU/mL. |
| High-dose Hook Effect | No hook effect at high concentrations | No hook to 50,000 IU/mL |
| Linearity | Linear across the assay's measuring range | Linear across the range of the assay (0.0 to 2500 IU/mL) |
| Limit of Blank (LoB) | Lowest measurement with no analyte | 0.9 IU/mL (n=221) |
| Limit of Detection (LoD) | Lowest detectable concentration (95% probability) | 0.9 IU/mL |
| Analytical Specificity | No significant interference; 100% agreement for autoimmune samples | No significant interference from total protein, bilirubin, hemoglobin, or triglycerides. 100% total agreement with autoimmune disease state samples. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 397 samples were used for the method comparison study. The LoB study used 221 samples. The number of samples for other studies (imprecision, linearity, analytical specificity) is not explicitly stated, although "samples with autoimmune disease state" were "tested" for analytical specificity.
- Data Provenance: Not explicitly stated (e.g., country of origin). The data is from a prospective study, as it involves running samples on both the new device and the predicate device for comparison and performance characterization.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This device is an in vitro diagnostic (IVD) immunoassay that measures an analyte (thyroglobulin antibody) directly. Therefore, there is no "ground truth" established by human experts in the way that would apply to image-based diagnostic AI. The "ground truth" for method comparison and performance comes inherently from the measurements of the predicate device and established analytical methods.
4. Adjudication Method for the Test Set
Not applicable, as the device is an immunoassay and does not involve human interpretation or adjudication for its raw output. The "comparison" is between the new device's quantitative output and the predicate device's quantitative output.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with AI vs. Without AI Assistance
Not applicable. This device is an automated immunoassay system, not an AI-assisted diagnostic tool that aids human readers in interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the studies described are standalone performance evaluations of the device (immunoassay system), as it functions as an automated system producing quantitative results. There is no "human-in-the-loop" component for the actual measurement process.
7. The Type of Ground Truth Used
The "ground truth" used for comparison, particularly in the method comparison study, is the quantitative measurement provided by the predicate device (Access Thyroglobulin Antibody II, K062516). For other performance metrics (imprecision, linearity, LoB, LoD), the "ground truth" is derived from established analytical methods and reference materials (e.g., NIBSC Anti-Thyroglobulin Serum, Human First International Reference Preparation, WHO Coded 65/93 for standardization).
8. The Sample Size for the Training Set
Not applicable. This device is an immunoassay, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. The "training" for such devices typically involves calibration using specific calibrators as described ("Utilizes a stored calibration curve").
9. How the Ground Truth for the Training Set Was Established
Not applicable. As described above, there isn't a "training set" in the AI/ML context. The calibration of the immunoassay system uses specific calibrators, and its standardization is based on NIBSC Anti-Thyroglobulin Serum, Human First International Reference Preparation, WHO Coded 65/93.
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