(56 days)
For in vitro diagnostic use in the quantitative determination of free thyroxine (FTA) 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 disease.
For in vitro diagnostic use in the quantitative determination of thyroxine (T4) in serum using the ADVIA Centaur and ADVIA Centaur XP systems. Measurements of thyroxine are used in the diagnosis and treatment of thyroid disease.
Not Found
The provided 510(k) summary focuses on the addition of pediatric reference intervals to existing ADVIA Centaur FT4 and T4 assays, rather than the development of a new device or a comparative effectiveness study involving AI. Therefore, many of the requested elements for a study proving device meets acceptance criteria (such as MRMC, standalone performance, ground truth establishment for training, etc.) are not directly applicable or explicitly detailed in this document.
However, based on the information provided, here's a breakdown of the acceptance criteria and the study conducted for the pediatric reference intervals:
1. A table of acceptance criteria and the reported device performance
The "acceptance criteria" here are implicitly tied to the established pediatric reference intervals themselves, and the "reported device performance" is the statistical summary of the patient data used to derive these intervals. The document states that the previously established euthyroid adult reference intervals and analytical measuring ranges already apply. The acceptance criteria for the pediatric reference intervals specifically are:
- The established pediatric reference intervals must be either within or above the previously established euthyroid adult reference intervals.
- The established pediatric reference intervals must be within the analytical measuring ranges of the ADVIA Centaur FT4 and T4 assays.
| Age Group | Pediatric Reference Interval (FT4) | Pediatric Reference Interval (T4) | Analytical Measuring Range (FT4) | Analytical Measuring Range (T4) | Euthyroid Adult Reference Interval (FT4) | Euthyroid Adult Reference Interval (T4) |
|---|---|---|---|---|---|---|
| Infants (01 - 23M) | 0.94 – 1.44 ng/dL | 6.03 – 13.18 µg/dL | 0.10 - 12.0 ng/dL | 0.30 - 30.00 µg/dL | 0.89 – 1.76 ng/dL | 4.50 - 10.90 µg/dL |
| Children (02 - 12Y) | 0.86 – 1.40 ng/dL | 5.50 - 12.10 µg/dL | 0.10 - 12.0 ng/dL | 0.30 - 30.00 µg/dL | 0.89 – 1.76 ng/dL | 4.50 - 10.90 µg/dL |
| Adolescents (13 - 21Y) | 0.83 – 1.43 ng/dL | 5.50 - 11.10 µg/dL | 0.10 - 12.0 ng/dL | 0.30 - 30.00 µg/dL | 0.89 – 1.76 ng/dL | 4.50 - 10.90 µg/dL |
As stated in the conclusions: "The newly-established pediatric reference intervals are either within or are above the previously-established reference intervals for euthyroid (normal thyroid) adult populations and they are within the analytical measuring ranges of the ADVIA Centaur FT4 and T4 assays." This confirms the device (when interpreted with these new intervals) meets its implicitly defined acceptance criteria.
2. Sample size used for the test set and the data provenance
- Sample Size: A total of 454 patients were analyzed: 72 infants, 190 children, and 129 adolescents.
- Data Provenance: Not explicitly stated, but typically reference interval studies use samples collected from healthy individuals within the specified age groups, often from multiple geographic locations to ensure generalizability. It's not specified if this was retrospective or prospective, though the term "analyzed" suggests it could have been retrospective analysis of collected samples.
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 summary. For establishing reference intervals, the "ground truth" is typically defined by recruiting a statistically robust population of "healthy" or "euthyroid" individuals based on clinical criteria and medical examination, rather than expert consensus on individual cases. The document refers to CLSI C28-A3c, which is a guideline for establishing reference intervals. This guideline outlines methods for selecting reference individuals and statistical methods for calculating intervals, but not necessarily "experts" in the sense of adjudicating individual cases.
4. Adjudication method for the test set
This information is not provided and is generally not applicable to the establishment of reference intervals. The process involves clinical selection criteria for healthy individuals and statistical determination of intervals.
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 submission is for updating reference intervals for an existing IVD assay, not for an AI-based device or a comparative effectiveness study involving human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
The device is an in vitro diagnostic (IVD) assay, not an algorithm or AI. Its performance is inherent in its analytical capabilities, which were previously established and cross-referenced to earlier 510(k) submissions (K905532, K080167, K971418). The current submission states, "The inclusion of pediatric reference intervals in the Instructions for Use (Package Inserts) does not necessitate the collection of additional analytical performance data." Therefore, no new standalone performance study was conducted for this submission as the analytical performance was deemed sufficient by previous submissions.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this type of study (establishing reference intervals), the "ground truth" is typically an "apparently healthy" or "euthyroid" state for the pediatric population, as defined by rigorous clinical selection criteria (e.g., absence of diseases, medications, or conditions known to affect thyroid function) as per CLSI guidelines. The specific criteria are not detailed but are implied by the reference to CLSI C28-A3c.
8. The sample size for the training set
This study is focused on establishing reference intervals, which typically involves a single dataset used for derivation. There isn't a "training set" in the context of machine learning. The 454 patients (72 infants, 190 children, 129 adolescents) constitute the dataset used to establish these reference intervals.
9. How the ground truth for the training set was established
As noted in point 7, the "ground truth" for the individuals included in the study (which acts as the "training set" for interval derivation) would be their status as "apparently healthy" or "euthyroid" pediatric individuals. This status would have been established through a process of screening, clinical assessment, and potentially other diagnostic tests, following the methodologies outlined in the CLSI C28-A3c guideline mentioned in the submission. The specific clinical criteria used for selection are not provided in this summary.
§ 862.1695 Free thyroxine test system.
(a)
Identification. A free thyroxine test system is a device intended to measure free (not protein bound) thyroxine (thyroid hormone) in serum or plasma. Levels of free thyroxine in plasma are thought to reflect the amount of thyroxine hormone available to the cells and may therefore determine the clinical metabolic status of thyroxine. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases.(b)
Classification. Class II.