(85 days)
DYNOtest anti-TPOn is a competitive radioimmunoassay for the quantitative determination of autoantibodies to thyroid peroxidase (TPO) in human serum using the coated tube technique. The DYNOtest anti-TPO, kit is used as an aid in the diagnosis of Hashimoto's thyroiditis and Graves' disease, autoimmune diseases affecting the thyroid gland.
DYNOtest anti-TPOn is a competitive radioimmunoassay intended for the quantitative determination of autoantibodies against thyroid peroxidase in human sera using a coated tube technique. Monoclonal antibodies against thyroid peroxidase bound to the solid phase compete with autoimmune anti-thyroid peroxidase antibodies in the sample for indirectly 12-1 labeled thyroid peroxidase. Following incubation, unreacted indirectly labeled thyroid peroxidase and unreacted 1251 labeled antibody against TPO is washed from the tube and radioactivity bound to the tube is counted. The measured radioactivity is inversely proportional to the quantity of anti-thyroid peroxidase antibody in the sample.
Here's an analysis of the provided text regarding the DYNOtest® anti-TPOn device, focusing on acceptance criteria and the supporting study:
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Overall agreement with predicate device (Orgentec Anti-TPO ELISA) | 81.8% |
Note: The document primarily focuses on demonstrating substantial equivalence to a predicate device rather than setting explicit quantifiable acceptance criteria for novel performance metrics. The 81.8% agreement is presented as sufficient to demonstrate substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 77 serum samples
- Data Provenance: The document does not explicitly state the country of origin. It indicates the samples were "from patients with Graves' disease, Hashimoto's thyroiditis and non-autoimmune thyroid disease," implying they were clinical samples, likely retrospective given the nature of a 510(k) submission for an already developed product. The study is a "clinical comparison."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The "ground truth" for the test set is established by comparing the DYNOtest anti-TPOn results to those of the predicate device, the Orgentec Anti-TPO ELISA. The performance of the predicate device itself is the reference. There's no mention of independent expert review of the 77 samples to establish a separate ground truth.
4. Adjudication Method for the Test Set
This information is not applicable/provided as there's no mention of individual expert assessment and subsequent adjudication. The comparison is directly between the new device and the predicate device's results. The 2x2 table shows the direct agreement and disagreement.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This device is an in vitro diagnostic (IVD) assay; therefore, human interpretation/reading of the assay results is not the primary focus in the same way it would be for an imaging AI device. The comparison is between two automated assay results.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance study was done. The "clinical comparison" directly compares the results of the DYNOtest anti-TPOn assay (the algorithm/device) to the results of the predicate Orgentec Anti-TPO ELISA. There is no human intervention or "human-in-the-loop" component in interpreting the quantitative results of either assay within this comparison.
7. The Type of Ground Truth Used
The "ground truth" for the comparison study is the results of the legally marketed predicate device, Orgentec Anti-TPO ELISA. The study evaluated whether the DYNOtest anti-TPOn agreed sufficiently with the established predicate device, which is a common approach for 510(k) submissions seeking substantial equivalence for IVD devices.
8. The Sample Size for the Training Set
This information is not provided and is generally not relevant for 510(k) submissions of traditional IVD assays like radioimmunoassays, as they are not "trained" in the typical machine learning sense. The device is a chemical/biological assay run on samples.
9. How the Ground Truth for the Training Set was Established
This information is not applicable/provided for the reasons mentioned above. There is no "training set" or "ground truth" establishment in the context of machine learning training 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).