(48 days)
The DSL-10-3100 T3 Enzymeimmunoassay (EIA) Kit provides materials for the guantitative measurement of T3 in serum. This assay is intended for in vitro diagnostic use in the diagnosis and treatment of thyroid diseases such as hyperthyroidism.
The ElA format is a competitive binding protein assay. Enzyme-labeled T3 competes with un-labeled T3 in the serum sample for binding sites with the Anti-T3 antibody in microtitration wells. Separation of free from bound T3 is achieved by washing and decanting the microtiter plates after incubation. The resultant is analyzed in a spectrophotometer for absorbance. The amount of enzyme-labeled T3 bound to the antibody is inversely proportional to the concentration of the T3 present in the sample.
The provided document describes the substantial equivalence of the DSL ACTIVE™ T3 EIA Kit to the DSL ACTIVE™ T3 RIA, not the acceptance criteria and study for a new device or algorithm in the way typically expected for AI/ML medical devices. The submission is for a traditional in-vitro diagnostic (IVD) kit.
Therefore, many of the requested categories are not directly applicable or are interpreted within the context of an IVD comparison rather than an AI/ML device study.
Here's an interpretation based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criterion for substantial equivalence in this context is based on a statistical comparison (linear regression and correlation coefficient) between the new device (DSL ACTIVE™ T3 EIA) and a legally marketed predicate device (DSL ACTIVE™ T3 RIA).
| Acceptance Criteria | Reported Device Performance | Comments |
|---|---|---|
| Linear correlation coefficient (r) between predicate and new device | r = 0.97 | This value indicates a strong positive linear relationship between the results of the two assays. |
| Regression equation | Y = 1.08(X) - 6.0 | This equation describes the relationship between the new device (Y) and the predicate device (X). An ideal relationship would be Y = X or Y = 1(X) + 0. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: n = 68 patient samples.
- Data Provenance: The document does not specify the country of origin. Samples were "chosen based on expected T3 levels so that samples with low, intermediate and high levels would be evaluated," indicating a strategic selection to cover the dynamic range of the assay. The study is implicitly retrospective as patient samples were "collected and assayed."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This concept is not applicable in the context of this submission. The "ground truth" for evaluating the new assay is the performance of the legally marketed predicate device (DSL ACTIVE™ T3 RIA) itself. The comparison is between two quantitative assays measuring the same analyte, not an expert-derived truth.
4. Adjudication Method for the Test Set
Not applicable. This is a quantitative comparison of two assays. There is no qualitative assessment or expert adjudication involved in generating the reference values or evaluating the results of the new device; raw numerical data from the predicate device serves as the reference.
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 not an AI/ML device or a diagnostic imaging device requiring human reader interpretation, hence no MRMC study or AI assistance evaluation was performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a laboratory immunoassay kit. Its performance is inherent to the kit's reagents and methodology, not an algorithm's standalone performance. The results are read by a spectrophotometer, which is a standard lab instrument.
7. The Type of Ground Truth Used
The "ground truth" for the performance evaluation of the DSL ACTIVE™ T3 EIA Kit was the quantitative measurement of T3 in human serum obtained from the predicate device, the DSL ACTIVE™ T3 RIA. This is a "comparative ground truth" against an existing, legally marketed device of the same type, rather than pathology, expert consensus, or outcomes data.
8. The Sample Size for the Training Set
Not applicable in the AI/ML sense. This device is a biochemical measurement kit. It does not involve a "training set" for model development. The development of the kit (e.g., reagent formulation, antibody selection) is not described in terms of machine learning training.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no "training set" in the context of an AI/ML model for this type of device, this question is not relevant.
§ 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.