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AxSYM® 3rd Generation TSH is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative determination of thyroid stimulating hormone (TSH) in human serum or plasma on the AxSYM System. The AxSYM 3rd Generation TSH assay is used as an aid in the assessment of thyroid status, diagnosis of thyroid disease, and treatment of thyroid disease.

AxSYM 3rd Generation TSH is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative determination of TSH in human serum or plasma. AxSYM 3rd Generation TSH is calibrated with Abbott AxSYM 3rd Generation TSH Calibrators. Abbott AxSYM 3rd Generation TSH Controls are assayed for the verification of the accuracy and precision of the AxSYM System.

This document describes the 510(k) summary for the Abbott AxSYM® 3rd Generation TSH, an in vitro diagnostic device. The submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, the AxSYM Ultrasensitive hTSH II assay.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are not explicitly stated as distinct thresholds against which the new device's performance is measured. Instead, the study aims to show substantial equivalence to a predicate device. The performance is reported in terms of statistical correlation and agreement between the new device and the predicate device.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: 921 specimens were used to compare the AxSYM 3rd Generation TSH assay with the AxSYM Ultrasensitive hTSH II assay.
• Data Provenance: The document does not explicitly state the country of origin for the data or whether it was retrospective or prospective. It refers to "human serum or plasma" specimens.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of study does not involve "experts" establishing a ground truth in the traditional sense of clinical diagnosis. Instead, the "ground truth" for comparison is the measurement obtained from the predicate device, the AxSYM Ultrasensitive hTSH II assay. Therefore, this section is not applicable in the context of this 510(k) submission.

4. Adjudication Method for the Test Set

Not applicable. The study compares the results of two assays directly on the same specimens. There is no adjudication process involving human reviewers for discrepancies between different measurements.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No. This is not an MRMC study. It is a method comparison study evaluating the performance of a new assay against a predicate assay.

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

Yes, in essence. This is a standalone performance evaluation of the analytical capabilities of the in vitro diagnostic device (the immunoassay) itself, as it compares the results generated by the device to those of a predicate device. It is not evaluating a human-in-the-loop scenario.

7. The Type of Ground Truth Used

The "ground truth" for this study is the analytical measurement provided by the predicate device, the AxSYM Ultrasensitive hTSH II assay. This is a common approach for demonstrating substantial equivalence for in vitro diagnostic assays. It is not based on expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" or its size. This type of submission (510(k) for an IVD) typically focuses on demonstrating the analytical performance of the final device against a predicate, rather than detailing the machine learning (ML) model development process which would include a training set. The term "calibration" is used in relation to the AxSYM 3rd Generation TSH Calibrators, but this refers to the routine calibration of the instrument and assay, not a machine learning training set.

9. How the Ground Truth for the Training Set Was Established

As no "training set" in the machine learning sense is described, this question is not applicable. The device is calibrated using "Abbott AxSYM 3rd Generation TSH Calibrators," which would involve reference materials with known TSH concentrations.

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