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The ThyroTest is a whole blood, qualitative assay for the detection of an increased level of TSH (Thyroid Stimulating Hormone). An increase level of TSH can be an indication of primary hypothyroidism. For professional use only.

Purified Polyclonal anti TSH antibodies are passively absorbed on the absorbent membrane. Anti-TSH monoclonal antibodies are absorbed on colloidal gold and then mixed in a protein matrix to obtain the final dye conjugate. Once applied to the specimen well, blood sample undergoes vertical capillary filtration through the porous filtration system. The blood cells are retained in the top layers while the liquid phase (plasma) reaches the bottom membrane layer. The buffer, when applied to the specimen well, flows along the bottom membrane layer, mixes with plasma and migrates horizontally along the test membrane. If TSH is present in the sample in concentrations at or above the detection level, labeled antibody-dye conjugates binds to it, forming an antigen-antibody-dye complex. This complex is then captured by antibody immobilized in the Test Zone ("T") of the membrane, producing a visible pink-rose color band on the membrane. A similarly colored conjugate is captured by a parallel immunochemical reaction in the Control Zone ("C") of the membrane. A distinctive control band is the marker of proper test performance.

Here's a summary of the acceptance criteria and the study that proves the ThyroTest device meets them, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

There are no explicit, pre-defined quantitative acceptance criteria stated in the document. However, the study aims to demonstrate substantial equivalence to an FDA-approved predicate device based on measures of agreement and correlation. The "Statement of Safety and Efficacy" section implies that achieving a high correlation, positive agreement, and negative agreement compared to an FDA-cleared method constitutes meeting safety and efficacy requirements.

Study Details

1. Sample size used for the test set and the data provenance:

   • Sample Size: 289 total participants.
   • Data Provenance: The study was a "three center clinical trial." The country of origin is not explicitly stated, nor is there an indication if it was retrospective or prospective. However, clinical trials are generally prospective in nature.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Number of Experts: Not applicable. The ground truth was established by a predicate device, the Abbott AxSYM, not human experts.
   • Qualifications of Experts: Not applicable.

3. Adjudication method for the test set:

   • Not applicable. The ground truth was established by a single, pre-existing FDA-approved device (Abbott AxSYM), not through an adjudication process among human readers.

4. 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 multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study compared a new device (ThyroTest) to a predicate device (Abbott AxSYM), not human readers with and without AI assistance.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • Yes, this was a standalone performance study. The ThyroTest itself is a qualitative assay (a rapid diagnostic test), and its performance was directly compared to the predicate device. While a "trained Laboratory Technician performed testing," this is the standard operation for such a device, and the device's output (positive/negative) is the primary focus of the comparison.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The ground truth was established by comparison to the Abbott AxSYM TSH method, which is identified as an "approved FDA TSH method." This serves as a reference standard.

7. The sample size for the training set:

   • The document does not provide information about a separate training set. The clinical trial data (N=289) appears to be the primary dataset for performance evaluation. Rapid diagnostic tests like ThyroTest typically do not have a "training set" in the machine learning sense, as their chemistry and assay design are fixed.

8. How the ground truth for the training set was established:

   • Not applicable, as no separate training set is described. If one were to consider the initial development and validation of the ThyroTest (not detailed in this summary), the ground truth for establishing its operational characteristics would likely have involved comparison to established laboratory methods or reference materials.

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