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510(k) Data Aggregation
(238 days)
The FT4L method is an in vitro diagnostic test for the quantitative measurement of Free Thyroxine in human serum and plasma on the Dimension® EXL™ integrated chemistry system with LOCI® Module. Measurements of free thyroxine are used in the diagnosis and monitoring of thyroid disease.
The TSHL method is an in vitro diagnostic test for the quantitative measurement of Thyroid Stimulating Hormone (TSH, thyrotropin) in human serum and plasma on the Dimension® EXL™ integrated chemistry system with LOCI® Module. Measurements of TSH are used in the diagnosis and monitoring of thyroid disease.
The Dimension® LOCI Free Thyroxine Flex® reagent cartridge, FT4L and Dimension® LOCI Thyroid Stimulating Hormone Flex® reagent cartridge, TSHL are in vitro diagnostic tests for the quantitative measurement of Free Thyroxine and Thyroid Stimulating Hormone, respectively, in human serum and plasma on the Dimension® EXL™ integrated chemistry system with LOCI® Module. The submission is for the inclusion of pediatric reference intervals to the labeling (Package Inserts) of these assays. No changes were made to the reagents, device design, or manufacturing process.
The provided document is a 510(k) summary for the Siemens Healthcare Diagnostics Dimension® LOCI Free Thyroxine Flex® Reagent Cartridge (FT4L) and Dimension® LOCI Thyroid Stimulating Hormone Flex® Reagent Cartridge (TSHL). The focus of this submission is the addition of pediatric reference intervals to the existing devices, not a primary submission for a new device. Therefore, the information provided primarily pertains to the establishment of these pediatric reference intervals.
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1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the pediatric reference intervals are defined by the statistical methods used to establish them and the resulting intervals. The performance reported is the calculated pediatric reference intervals.
| Acceptance Criteria | Reported Device Performance (FT4L) | Reported Device Performance (TSHL) |
|---|---|---|
| Infant (01-23 months): Reference interval established using robust symmetrical method due to sample size < 120, validated against simulated non-parametric and robust symmetric intervals. | Reference Interval: 0.93 - 1.45 ng/dL | Reference Interval: 0.867 – 6.43 µIU/mL (Established using robust symmetrical method after log transformation due to skewed data) |
| Children (02-12 years): Reference interval established using non-parametric approach (2.5th and 97.5th percentiles). | Reference Interval: 0.82 - 1.40 ng/dL | Reference Interval: 0.704 - 4.01 µIU/mL |
| Adolescents (13-20 years): Reference interval established using non-parametric approach (2.5th and 97.5th percentiles). | Reference Interval: 0.78 - 1.34 ng/dL | Reference Interval: 0.516 - 4.13 µIU/mL |
| Confidence Intervals for Infant 95% Reference Intervals: 90% confidence intervals for lower and upper limits. | 90% CI of Lower Limit: 0.89 - 0.97 ng/dL 90% CI of Upper Limit: 1.41 - 1.50 ng/dL | 90% CI of Lower Limit: 0.710 - 1.04 µIU/mL 90% CI of Upper Limit: 5.40 - 7.54 µIU/mL |
2. Sample Size Used for the Test Set and the Data Provenance
The "test set" in this context refers to the patient samples used to establish the pediatric reference intervals.
- FT4L Assays: Data from a total of 411 patients
- Infants (01 – 23 months): 77 patients
- Children (02 – 12 years): 187 patients
- Adolescents (13 – 20 years): 147 patients
- TSHL Assays: Data from a total of 407 patients
- Infants (01 – 23 months): 75 patients
- Children (02 – 12 years): 185 patients
- Adolescents (13 – 20 years): 147 patients
Data Provenance: The document does not specify the country of origin. It also doesn't explicitly state whether the data was retrospective or prospective, but the phrasing "Data ... were analyzed to establish the reference intervals" suggests it was likely 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
The ground truth here is the definition of "healthy" individuals within the pediatric age groups to establish reference intervals. The document does not mention the use of experts to establish individual ground truths for each sample in the test set. Instead, it refers to a population used to establish the reference intervals. The underlying assumption is that these patients were deemed healthy for their age group. The statistical methods (CLSI C28-A3c, CLSI EP28-A3) mentioned are standard guidelines for establishing reference intervals in clinical laboratories, which are developed and endorsed by experts in the field of clinical pathology and laboratory medicine, but individual experts are not described as adjudicating each case.
4. Adjudication Method for the Test Set
No explicit adjudication method (e.g., 2+1, 3+1) is mentioned for the test set. The process involves collecting samples presumably from healthy individuals within the pediatric age groups and applying statistical methods guided by CLSI standards to determine the reference 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
This section is not applicable. The device (reagent cartridge) is an in vitro diagnostic test for quantitative measurement of hormones, not an imaging device or an AI-driven tool requiring human reader interpretation in the manner of an MRMC study. The study focuses on establishing reference intervals for a laboratory test.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable. The device is a laboratory reagent. The "performance" being evaluated here is the ability to accurately define reference intervals for existing assays, which is a statistical and clinical validation task, not an algorithm's standalone performance in the typical sense of AI. The assay itself works in a standalone (automated) manner on the Dimension® EXL™ system with LOCI® Module. The current submission's scope is the labeling modification to add pediatric reference intervals.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for establishing pediatric reference intervals is based on healthy pediatric populations. The individuals included in the study for establishing reference intervals are assumed to be "healthy" (euthyroid, meaning normal thyroid function) for their age group. This is a common method for establishing reference ranges in laboratory medicine, following guidelines like CLSI C28-A3c. It's not individual expert consensus on specific cases, pathology reports, or long-term outcomes data, but rather a statistical representation of a healthy population.
8. The Sample Size for the Training Set
This submission is about establishing reference intervals, which traditionally does not involve a "training set" in the machine learning sense. The patient data described in point 2 is used directly to establish the reference intervals, rather than training an algorithm.
9. How the Ground Truth for the Training Set Was Established
As explained above, there isn't a "training set" in the typical AI/ML context. The patient samples used to establish the reference intervals are assumed to be from "healthy" individuals in the respective pediatric age groups, following standard clinical laboratory guidelines for reference interval studies.
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