(21 days)
DPC's IMMULITE® Free T3 is a chemiluminescent assay for use with the IMMULITE® Automated Immunoassay Analyzer and is designed for the quantitative measurement of Free T3 in serum. It is intended strictly for in vitro diagnostic use as an aid in clinical assessment of thyroid status.
Free T3 is a solid-phase, IMMULITE® Chemiluminescent enzyme immunoassay for use with the IMMULITE® Automated Immunoassay Analyzer.
Here's a breakdown of the acceptance criteria and study information for the Diagnostic Products Corporation IMMULITE® Free T3 device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document doesn't explicitly state quantitative acceptance criteria in a pass/fail format for a primary outcome. Instead, it demonstrates performance by comparing the IMMULITE® Free T3 assay to a legally marketed predicate device (Chiron Diagnostics' ACS:180 Free T3) through a method comparison. The acceptance is implied by the "substantial equivalence" determination by the FDA.
| Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance (IMMULITE® Free T3 vs. ACS:180 Free T3) |
|---|---|
| Demonstrates comparable performance to the predicate device, Chiron Diagnostics' ACS:180 Free T3, for quantitative measurement of non-protein-bound triiodothyronine (free T3) levels in serum, as an aid in the clinical assessment of thyroid status. | Linear Regression Analysis: (IMMULITE® Free T3 2-Step) = 0.99 (ACS:180 Free T3) - 0.11 pg/mL, with a correlation coefficient (r) = 0.930. |
| Mean Values: 3.13 pg/mL (IMMULITE® Free T3 2-Step) vs. 3.28 pg/mL (ACS:180 Free T3) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 237 patient samples.
- Data Provenance: Not explicitly stated (e.g., country of origin). The samples are referred to as "patient samples," which typically implies prospective or retrospective collection from a clinical setting, but it's not specified. It is a retrospective study since it compares the device to an existing predicate device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This information is not provided in the document. The study is a method comparison against a predicate device, not a diagnostic accuracy study establishing ground truth based on expert consensus.
4. Adjudication Method for the Test Set
This information is not applicable as the study is a method comparison between two assays, not a diagnostic performance study requiring adjudication of expert interpretations.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study focuses on the analytical performance of the new device compared to an existing one.
6. Standalone (Algorithm Only) Performance Study
This is an in vitro diagnostic (IVD) device, not an algorithm in the typical sense of AI. The performance reported is the standalone performance of the IMMULITE® Free T3 assay in direct comparison with the ACS:180 Free T3 assay. There is no human-in-the-loop component described for its operation or interpretation beyond the standard laboratory workflow.
7. Type of Ground Truth Used
The "ground truth" in this context is the results obtained from the predicate device (Chiron Diagnostics' ACS:180 Free T3 assay). The study aims to demonstrate that the new IMMULITE® Free T3 assay provides comparable results to an already legally marketed and established assay for free T3 measurement.
8. Sample Size for the Training Set
This information is not provided and is largely not applicable in the same way it would be for a machine learning algorithm. The IMMULITE® Free T3 device is a chemiluminescent immunoassay, and its "training" or optimization would involve laboratory development and calibration, not a traditional machine learning training set. The standard curve (mentioned as "stored" and "calibrated") is analogous to a training phase in a broader sense, but the specific sample size for its establishment is not detailed.
9. How the Ground Truth for the Training Set Was Established
Similar to point 8, this information is not explicitly detailed in the document. For an immunoassay, the "ground truth" for calibration curves is typically established using a series of known concentration standards of free T3. These standards would be meticulously prepared and verified to ensure accurate calibration of the assay.
§ 862.1710 Total triiodothyronine test system.
(a)
Identification. A total triiodothyronine test system is a device intended to measure the hormone triiodothyronine in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases such as hyperthyroidism.(b)
Classification. Class II. This device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.