(52 days)
The ARCHITECT™ Free Ts (FT2) assay is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of free triiodothyronine (free T3) in human serum and plasma. The ARCHITECT Free T3 assay is to be used as an aid in the assessment of thyroid status.
ARCHITECT Free T, is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of free T, in human serum and plasma (lithium heparin, sodium heparin or potassium EDTA). ARCHITECT Free T2 is calibrated with ARCHITECT Free T2 Calibrators. ARCHITECT Free T2 Controls are assayed for the verification of the accuracy and precision of the Abbott ARCHITECT i System.
This 510(k) summary describes a traditional device equivalence study rather than an AI/ML-based device study. Therefore, many of the requested categories are not applicable.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| The criteria for acceptance are implicit: to demonstrate substantial equivalence to the predicate device (AxSYM® Free T3 assay) in terms of quantitative determination of free T3. | Least squares linear regression: correlation coefficient = 0.958, slope = 0.82, y-axis intercept = 0.94 pg/mL. |
| Passing-Bablok linear regression: correlation coefficient = 0.958, slope = 1.05, y-axis intercept = 0.21 pg/mL. |
Explanation of Acceptance Criteria: The document directly states that "Substantial equivalence has been demonstrated between the ARCHITECT Free T3 assay and the AxSYM® Free T3 assay." This implies that the statistical metrics (correlation, slope, intercept) were compared against a pre-defined range of acceptable values (often based on clinical relevance or previous regulatory approvals for similar devices) to determine if the new device performed similarly enough to the predicate. The specific thresholds for these metrics (e.g., minimum correlation coefficient, acceptable range for slope and intercept) are not explicitly stated in this summary but would have been part of the full submission.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 1101 specimens
- Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. It only states "human serum and plasma."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This is not applicable to this type of in vitro diagnostic device study. The "ground truth" for quantitative assays is typically established by the reference method (the predicate device in this case) and traceable standards, not by expert consensus.
4. Adjudication Method for the Test Set
- Not applicable. Adjudication is typically for subjective assessments (e.g., image interpretation), not for quantitative chemical assays.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. This is an analytical performance study comparing two quantitative assays, not a diagnostic accuracy study involving human readers interpreting outputs.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes, in a sense. The study assesses the performance of the ARCHITECT Free T3 assay (the "device" being evaluated) in comparison to the AxSYM® Free T3 (the "predicate device"). Both are automated or semi-automated assays, and their output is a quantitative value, not subject to human interpretation in the same way an AI output would be. The study focuses purely on the analytical performance of the device itself.
7. The Type of Ground Truth Used
- Predicate Device Comparison: The "ground truth" or reference for comparison was the AxSYM® Free T3 assay. This is a common approach for 510(k) submissions where a new device's performance is demonstrated to be substantially equivalent to an already legally marketed device with the same intended use.
8. The Sample Size for the Training Set
- Not applicable. This is an analytical validation of an in vitro diagnostic device, not an AI/ML model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. (See point 8)
§ 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.