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Abbott ARCHITECT™ TSH is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of thyroid stimulating hormone (TSH) in human serum and plasma. The ARCHITECT TSH assay is to be used as an aid in the assessment of thyroid status, diagnosis of thyroid disease, and treatment of thyroid disease.

ARCHITECT TSH is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of TSH in human serum and plasma (lithium heparin, sodium heparin, or potassium EDTA). ARCHITECT TSH is calibrated with ARCHITECT TSH Calibrators. ARCHITECT TSH Controls are assayed to verify the accuracy and precision of the Abbott ARCHITECT i System.

The provided text describes the Abbott ARCHITECT™ TSH device, an in vitro diagnostic assay, and its demonstration of substantial equivalence to a predicate device, the AxSYM® Ultrasensitive hTSH assay.

Here's an analysis of the provided information against your requested categories:

1. A table of acceptance criteria and the reported device performance

Note: The document implicitly defines acceptable performance through the reported metrics demonstrating substantial equivalence to the predicate device. Specific numerical "acceptance criteria" for these metrics are not explicitly stated, but the strong correlation and narrow confidence intervals indicate acceptable performance for substantial equivalence.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: 534 specimens.
• Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective.

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

• This information is not provided in the document. The "ground truth" for this type of assay comparison is typically derived from the predicate device's results.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments. For a quantitative immunoassay comparison, direct numerical comparison to a predicate device usually serves as the validation method. Therefore, an explicit adjudication method is not applicable/not mentioned.

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

• This is an in vitro diagnostic device (IVD) assay, not an AI-assisted diagnostic imaging or human-read interpretation system. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not done.

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

• Yes, this was a standalone performance study as it evaluated the performance of the ARCHITECT TSH assay (the "algorithm") directly against a predicate device, without human intervention in the result generation or comparison process beyond standard laboratory procedures.

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

• The "ground truth" in this context is the results obtained from the legally marketed predicate device, the AxSYM® Ultrasensitive hTSH assay. The new device's performance is compared against the established performance of the predicate device to demonstrate substantial equivalence.

8. The sample size for the training set

• This involves an in vitro diagnostic assay with a chemical reaction, not a machine learning algorithm that typically requires a distinct "training set." Therefore, the concept of a "training set" as understood in AI/ML is not applicable to this type of study. The 534 specimens likely represent the entire dataset used for demonstrating equivalence.

9. How the ground truth for the training set was established

• As a "training set" in the AI/ML sense is not applicable, the method for establishing its "ground truth" is also not applicable. For the overall study, the predicate device's results served as the reference standard.

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