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The ADVIA Centaur FT4 Immunoassay is for in vitro diagnostic use in the quantitative determination of free thyroxine (FT4) in serum or plasma (heparinized or EDTA) using the ADVIA Centaur and ADVIA Centaur XP Systems. Measurements of free thyroxine are used in the diagnosis and treatment of thyroid diseases.

The ADVIA Centaur FT4 assay is a competitive immunoassay using direct, chemiluminescent technology. Free thyroxine in the patient sample competes with acridinium ester-labeled T4 in the Lite Reagent for a limited amount of biotinylated polyclonal rabbit anti-T4 antibody that is bound to avidin that is covalently coupled to paramagnetic particles in the Solid Phase. There is an inverse relationship between the concentration of free thyroxine in the sample and relative light units (chemiluminescence).

Here's a breakdown of the acceptance criteria and study information for the ADVIA Centaur FT4 Immunoassay, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

The provided document describes the performance characteristics without explicitly stating pre-defined "acceptance criteria" but rather demonstrates substantial equivalence to a predicate device. For the purpose of this analysis, we can infer acceptance criteria as demonstrating comparable performance to the predicate device within reasonable experimental variation.

Table of Acceptance Criteria (Inferred) and Reported Device Performance

Study Details

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

   • Method Comparison (Serum vs. ACS:180 FrT4): N=283
   • Serum / Plasma Equivalency (Heparinized Plasma vs. Serum): N=133
   • Serum / Plasma Equivalency (EDTA Plasma vs. Serum): N=108
   • Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It is typical for such studies to use prospectively collected clinical samples or spiked samples, but this is not confirmed.

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

   • Not applicable. This device is an in vitro diagnostic (IVD) immunoassay measuring a biochemical marker (FT4 concentration) directly. The "ground truth" for the test set primarily relies on the results obtained from a legally marketed, predicate device (ACS:180 FrT4 Immunoassay) and established laboratory methods. It does not involve expert interpretation of images or clinical assessments in the way a diagnostic imaging AI would.

3. Adjudication method for the test set:

   • Not applicable. Since the ground truth is established by quantitative measurement and comparison to a predicate device, there is no expert adjudication process involving multiple readers/interpreters.

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. This is an IVD device for quantitative measurement of a biochemical marker, not a diagnostic imaging or interpretive AI device. Therefore, an MRMC study involving human readers is not applicable.

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

   • Yes, effectively. The performance data presented (imprecision, specificity, interfering substances, correlation, serum/plasma equivalency) represents the standalone analytical performance of the ADVIA Centaur FT4 Immunoassay system. This is a "device only" performance evaluation without human interpretive intervention in the measurement process itself.

6. The type of ground truth used:

   • The ground truth for evaluating the new device's analytical performance is primarily established by:
     • Measurements from a legally marketed predicate device: The ACS:180 FrT4 Immunoassay (K961510) served as the primary comparison for method correlation.
     • Known concentrations: For studies like specificity (cross-reactivity) and interfering substances, the "ground truth" involves starting with known concentrations of the analyte and interferents.
     • Internal standards (USP): The assay's standardization references an Internal Standard (USP), implying a traceable reference material for quantitative accuracy.

7. The sample size for the training set:

   • Not applicable. This document describes an immunoassay (laboratory test), not a machine learning or AI algorithm in the context of "training data." The device's performance is based on its chemical and immunological design, not on being "trained" on a dataset in the AI sense.

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

   • Not applicable. As stated above, this is not an AI/machine learning device that requires a training set with established ground truth. The assay's design and calibration are based on established scientific principles of immunoassay technology and reference materials.

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