(48 days)
The DSL-10-3200 T4 Enzymeimmunoassay (EIA) Kit provides materials for the quantitative measurement of T4 in serum. This assay is intended for in vitro diagnostic use in the diagnosis and treatment of thyroid disease.
The DSL ACTIVE™ T4 EIA kit was developed for the quantitative measurement of T4 in human serum. The EIA format is a competitive binding protein assay. Enzyme-labeled T4 competes with un-labeled T4 in the serum sample for binding sites with the Anti-T4 antibody in microtitration wells. Separation of free from bound T4 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 T4 bound to the antibody is inversely proportional to tne concentration of the T4 present in the sample.
The provided text describes a 510(k) submission for the "DSL ACTIVE™ T4 EIA Kit" and its substantial equivalence to a predicate device, the "DSL ACTIVE™ T4 RIA." The study focuses on demonstrating this equivalence rather than establishing acceptance criteria and testing against them in the traditional sense of a clinical trial for a novel device.
However, we can extract the relevant information regarding the performance comparison to demonstrate substantial equivalence, which serves as a form of "acceptance criteria" for regulatory purposes in this context.
Here's the breakdown:
1. Table of Acceptance Criteria and Reported Device Performance
For a 510(k) submission demonstrating substantial equivalence, the "acceptance criteria" revolve around showing comparable performance to a legally marketed predicate device. In this case, the key metric is the correlation between the new device and the predicate.
| Acceptance Criteria | Reported Device Performance (DSL ACTIVE™ T4 EIA Kit vs. DSL ACTIVE™ T4 RIA) |
|---|---|
| Strong linear correlation with predicate device | Linear regression equation: Y = 0.72(X) - 0.24 |
| Correlation coefficient (r): 0.96 | |
| (Indicating a strong positive linear relationship) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 59 patient samples (n=59)
- Data Provenance: The document does not explicitly state the country of origin. It mentions "patient samples were collected." It is a retrospective comparison, as the samples were collected and then assayed using both methods for comparison.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This type of study does not involve "experts establishing ground truth" in the way a diagnostic imaging study might. Instead, the predicate device (DSL ACTIVE™ T4 RIA) itself served as the reference standard against which the new device's performance was compared. The "ground truth" for the T4 levels in the samples was established by the predicate device's readings. No human experts were involved in establishing the T4 values for comparison in this regulatory context.
4. Adjudication Method for the Test Set
No adjudication method was used for the test set. The study directly compared the measurements obtained from the new device with those from the predicate device through linear regression.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This study is an in-vitro diagnostic device comparison, not a human reader performance study. Therefore, an MRMC study and effect size for human readers are not applicable.
6. Standalone Performance (Algorithm only without human-in-the-loop performance)
Yes, in essence, this is a standalone performance study of the DSL ACTIVE™ T4 EIA Kit. The kit (an enzyme immunoassay) is an automated or semi-automated system that provides a quantitative measurement. The performance being evaluated is the kit's ability to measure T4 levels compared to the predicate device, not its interaction with a human operator for interpretation.
7. Type of Ground Truth Used
The "ground truth" for the T4 levels in the patient samples was established by the predicate device, the DSL ACTIVE™ T4 RIA. This is a common approach in 510(k) submissions where a new device is compared to a legally marketed device as a reference.
8. Sample Size for the Training Set
The document does not mention a separate "training set" or "training data" size. This type of submission, focused on demonstrating substantial equivalence, typically relies on a comparison study with a predicate device. The DSL ACTIVE™ T4 EIA kit was "developed" for T4 measurement, implying internal optimization, but details about training data used in its development are not provided in this regulatory summary.
9. How the Ground Truth for the Training Set Was Established
Given that no explicit training set or its size is provided, the method for establishing its ground truth is also not mentioned. Immunoassay development involves calibrators and controls, but these are part of the assay's design and validation rather than a "ground truth" for a machine learning model's training set as might be seen in AI device development.
§ 862.1700 Total thyroxine test system.
(a)
Identification. A total thyroxine test system is a device intended to measure total (free and protein bound) thyroxine (thyroid hormone) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.