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DPC's IMMULITE® Free T4 is intended for use with the IMMULITE® Automated Analyzer. It is a solid-phase, 2-step chemiluminescent enzyme immunoassay designed for the quantitative measurement of non-protein-bound thyroxine (free T4) levels in serum. It is intended strictly for in vitro use as an aid in the clinical assessment of thyroid status related to abnormality in thyroid function or simply a variation (physiological or pathological) in the carrier proteins, chief of which is thyroxine-binding globulin (TBG). This assay is useful in assessment of thyroid status due to TBG elevations typical of pregnancy, oral contraceptive use and estrogen therapy. Additionally, this test system is for use as an aid in detecting alterations in the TBG level which mask the effects of abnormal thyroid function in hypothyroid and hyperthyroid patients.

IMMULITE® Free T4 (2-Step) is a solid-phase, Chemiluminescent enzyme immunoassay for use with the IMMULITE® Automated Immunoassay Analyzer.

This document is a 510(k) premarket notification for the IMMULITE® Free T4 (2-Step) Reagent system. It seeks to demonstrate substantial equivalence to a predicate device, the DPC's Coat-A-Count® Free T4. As such, the study described is a method comparison study intended to show that the new device performs similarly to the already marketed predicate device, rather than establishing de novo acceptance criteria solely based on the device's intrinsic performance.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for substantial equivalence are implicitly based on a strong correlation and agreement with the predicate device. The document does not explicitly state numerical acceptance criteria (e.g., minimum R-squared value, maximum bias). However, the results presented are intended to demonstrate that these unstated criteria were met.

2. Sample size used for the test set and the data provenance

• Sample size for the test set: 172 patient samples.
• Data provenance:
  • Country of origin: Not explicitly stated.
  • Retrospective or prospective: Not explicitly stated, but the mention of "patient samples" typically implies retrospective collection for a method comparison of this type.

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

This type of study (method comparison for an in vitro diagnostic device) does not typically involve human expert readers establishing ground truth in the way image analysis or clinical diagnosis studies do. The "ground truth" for the test set is established by the predicate device's measurement (Coat-A-Count® Free T4). Therefore, this section is not applicable in the traditional sense. The predicate device itself is considered the "expert" or reference method for comparison.

4. Adjudication method for the test set

Not applicable. As explained above, the "ground truth" is the measurement from the predicate device. There is no human adjudication process described for reconciling differences between the new device and the predicate in this context.

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

Not applicable. This is a study comparing two automated in vitro diagnostic (IVD) devices for measuring Free T4 in serum. It is not an MRMC study and does not involve AI assistance for human readers.

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

Yes, this was a standalone performance study of the IMMULITE® Free T4 (2-Step) assay. The comparison was entirely between the measurements generated by the new automated system and the measurements generated by the predicate automated system. There is no human-in-the-loop component described for the measurement process itself.

7. The type of ground truth used

The "ground truth" for this comparative study was the measurements obtained from the predicate device, DPC's Coat-A-Count® Free T4 assay. This predicate device is an established, legally marketed assay for Free T4.

8. The sample size for the training set

Not applicable. This document describes a validation study for a device. For IVD assays, "training set" is not typically a concept explicitly described in the same way as for machine learning algorithms. The device's components (reagents, analyzer system) are developed by the manufacturer, and their performance characteristics are optimized during that development process rather than being "trained" on a specific dataset in the statistical learning sense. The provided text refers to a method comparison study for showing equivalence, not a development or training phase.

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

Not applicable, as a training set in the machine learning sense is not described for this type of IVD device validation. The established reference method (Coat-A-Count® Free T4) serves as the comparator for the validation study, rather than a "ground truth" for a training set.

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