(299 days)
The Thyretain ™ TSI Reporter BioAssay is intended for the qualitative detection in serum of thyroid stimulating autoantibodies to the thyroid stimulating hormone (TSH) receptors (TSHRs) on the thyroid. The detection of these stimulating autoantibodies, in conjunction with other clinical and laboratory findings, may be useful as an aid in the differential diagnosis of patients with Graves' disease (GD).
The number of wells tested per Positive, Reference and Negative control has been reduced from three to two for each. The number of wells tested per patient specimen has been reduced from three to two.
The provided submission (K092229) is a special 510(k) for a device modification; therefore, it primarily focuses on demonstrating that the device, post-modification, remains substantially equivalent to its predicate device. This type of submission usually doesn't include new, large-scale clinical studies with specific acceptance criteria as would be found in a De Novo or PMAs. Instead, it relies on bridging data to show the modification doesn't negatively impact performance.
Here's an analysis based on the provided text:
Device: Thyretain™ TSI Reporter BioAssay (Modified)
Predicate Device: Thyretain™ TSI Reporter BioAssay (K083391)
Modification: Reduction of the number of wells tested per Positive, Reference, and Negative control from three to two. Reduction of wells tested per patient specimen from three to two.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state formal acceptance criteria in a quantitative manner (e.g., "sensitivity must be >90%"). Instead, the performance assessment aims to demonstrate that the modified device remains equivalent to the predicate, particularly in its non-clinical performance.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| No significant negative impact on device performance due to modification. | "Based on the analysis of the study site data (see Attachment 2) the modification poses little risk." |
| Maintain the intended use and diagnostic accuracy. | Intent to maintain the same intended use as the predicate device. The FMEA indicated little risk from the modification. |
Note: "Attachment 2" which would contain the detailed study site data is not provided in the input, so specific quantitative performance metrics like sensitivity, specificity, or agreement with the predicate are not available in this summary. The assessment focuses on risk analysis.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document refers to "study site data" in "Attachment 2". However, the details of this data, including sample size, provenance (country of origin), and whether it was retrospective or prospective, are not provided in the given text extract.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the given text extract. Given this is a modification to an in vitro diagnostic (IVD) device, the ground truth would likely refer to established diagnostic methods or clinical outcomes, rather than expert interpretation of images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the given text extract. It is unlikely to be relevant for this type of IVD modification, which assesses analytical performance rather than interpretation by human readers.
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
No. A MRMC comparative effectiveness study was not done. This is an in vitro diagnostic device (a bioassay) for detecting autoantibodies, not an imaging device that requires human interpretation or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable in the context of this device. The Thyretain™ TSI Reporter BioAssay is a laboratory assay for detecting antibodies, not an algorithm. The "performance" refers to the analytical performance of the assay itself. The submission is not about an algorithm, but a modification to the assay's procedure (number of wells).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The submission is for an immunoassay. The ground truth for such an assay would typically be established by:
- Reference methods: Comparison to established, clinically validated assays for the same analyte.
- Clinical diagnosis: Correlation with the clinical diagnosis of Graves' disease (GD), which would involve a combination of clinical symptoms, other laboratory findings, and potentially outcomes data over time.
- Pathology: Less likely to be the primary ground truth for an antibody assay, but could be part of the broader clinical picture for Graves' disease.
The provided text does not explicitly state the type of ground truth used for the "study site data" referenced.
8. The sample size for the training set
This information is not provided in the given text extract. For an IVD assay modification, there isn't typically a "training set" in the machine learning sense. Any data used to validate the modified procedure would be considered a "test set" or verification/validation data.
9. How the ground truth for the training set was established
As there is no "training set" in the context of this IVD device, this question is not applicable. Any ground truth for validation samples would be established by methods similar to those described in point 7.
§ 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).