(85 days)
DYNOtest anti-Tgn is a competitive radioimmunoassay (RIA) for the quantitative determination of autoantibodies against thyroglobulin (Tg) in human serum using the coated tube technique. The DYNOtest anti-Tg, kit is used as an aid in the diagnosis of Hashimoto's thyroiditis and Graves' disease, autoimmune diseases affecting the thyroid gland.
DYNOtest anti-Tg, is a competitive radioimmunoassay intended for the quantitative determination of autoantibodies against thyroglobulin in human sera using a coated tube technique. Human polyclonal antibodies against thyroglobulin bound to the solid phase compete with autoimmune antithyroglobulin antibodies in the sample for 1351 labeled thyroglobulin. Following incubation, unreacted labeled thyroglobulin is washed from the tube and radioactivity bound to the tube is counted. The measured radioactivity is inversely proportional to the quantity of anti-thyroglobulin antibody in the sample.
Here's an analysis of the provided text regarding the DYNOtest® anti-Tgn device, focusing on acceptance criteria and supporting study details:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly define acceptance criteria as a standalone quantitative metric (e.g., "sensitivity must be >X%"). Instead, it focuses on demonstrating substantial equivalence to a predicate device. The performance is assessed through a direct comparison where the agreement between the new device and the predicate device is the key metric.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device based on overall agreement. | Overall Agreement: 70.3% with the Orgentec Anti-Tg ELISA. |
| Comparable performance characteristics. | Shown through the 70.3% agreement in diagnosing autoimmune thyroid diseases. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 74 serum samples.
- Data Provenance: The document states the samples were "from patients with Graves' disease, Hashimoto's thyroiditis and non-autoimmune thyroid disease." The country of origin is not specified, nor is whether the data was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
The document explicitly states that the ground truth for this comparison study was the results obtained from the predicate device, the Orgentec Anti-Tg ELISA (K952130). Therefore, no human experts were directly involved in establishing the ground truth for this particular comparison. The predicate device's performance established the reference.
4. Adjudication Method for the Test Set
Not applicable. The "ground truth" was the result from the predicate device; therefore, no expert adjudication was required or performed.
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
Not applicable. This device is an in vitro diagnostic (IVD) assay, not an AI-assisted diagnostic tool or an imaging device requiring human interpretation. The study is a comparative effectiveness study between two IVD kits.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
Yes, in the context of an IVD, the comparison study against the predicate device effectively functions as a standalone performance evaluation of the DYNOtest® anti-Tgn assay. It evaluates the kit's performance independently without human interpretation influencing the final result beyond conducting the assay.
7. The Type of Ground Truth Used
The ground truth used for the comparison study was the results obtained from the legally marketed predicate device, the Orgentec Anti-Tg ELISA (K952130). This functions as a "reference standard" rather than a clinical ground truth like pathology or expert consensus. Patients were characterized by their diagnoses (Graves', Hashimoto's, non-autoimmune thyroid disease), but the direct comparison was against the predicate's output.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/Machine Learning device that requires a separate training set. The study describes the validation of an IVD kit.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
§ 866.5870 Thyroid autoantibody immunological test system.
(a)
Identification. A thyroid autoantibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the thyroid autoantibodies (antibodies produced against the body's own tissues). Measurement of thyroid autoantibodies may aid in the diagnosis of certain thyroid disorders, such as Hashimoto's disease (chronic lymphocytic thyroiditis), nontoxic goiter (enlargement of thyroid gland), Grave's disease (enlargement of the thyroid gland with protrusion of the eyeballs), and cancer of the thyroid.(b)
Classification. Class II (performance standards).