(35 days)
The DSL hGH IRMA assay is intended for the quantitative determination of hGH in human serum. The measurement of hGH is used as a diagnostic aid in the evaluation of hGH deficiency disorders or acromegaly.
The DSL 1900 hGH IRMA kit was developed for the quantitative measurement of hGH in human serum. The IRMA format is a non-competitive assay in which the analyte to be measured is "sandwiched" between two antibodies. The first antibody is immobilized to the coated tube, the other antibody is radiolabelled for detection. The analyte present is bound by both the antibodies to form a "sandwiched" complex. Unbound materials are removed be decanting and washing the tube. The resultant is analyzed in a gamma counter for net counts. The amount of bound hGH is directly proportional to the concentration of the hGH present in the sample.
The provided text describes a DSL 1900 hGH IRMA Kit, an immunoradiometric assay for the quantitative determination of human growth hormone (hGH) in human serum. The primary "study" described is a method comparison study to demonstrate substantial equivalence to a predicate device, the DSL 10-1900 hGH ELISA.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The "acceptance criteria" here is implied by the goal of demonstrating substantial equivalence to the predicate device. The performance is measured by the linear regression analysis and correlation coefficient.
| Acceptance Criteria (Implied for Substantial Equivalence to Predicate) | Reported Device Performance (DSL 1900 hGH IRMA vs. DSL 10-1900 hGH ELISA) |
|---|---|
| Strong linear relationship between the two assays | Linear Regression Equation: Y = 0.93 (DSL 10-1900) - 0.19 |
| High correlation between the two assays | Correlation Coefficient (r): 0.97 |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 68 human serum samples
- Data Provenance: Human serum samples were collected. The text does not specify the country of origin. It is a retrospective analysis of collected samples.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This question is not applicable in the context of this device and study. The "ground truth" for a quantitative diagnostic assay of this type is typically the result from a reference method or a highly validated predicate device. In this case, the DSL 10-1900 hGH ELISA serves as the reference for comparison. There is no mention of expert human readers or their qualifications being used to establish ground truth for this type of assay.
4. Adjudication Method for the Test Set
Not applicable. This is a quantitative assay comparison study, not a study involving human interpretation that would require adjudication. The results from each assay (DSL 1900 hGH IRMA and DSL 10-1900 hGH ELISA) are directly compared.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This study is an analytical method comparison, not a study evaluating human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Yes, in a sense, a standalone performance was done. Both assays (the investigational DSL 1900 hGH IRMA and the predicate DSL 10-1900 hGH ELISA) operate as standalone laboratory tests without human-in-the-loop performance during the measurement phase. The study compares the results generated directly by these "algorithms" (i.e., the assay procedures and their interpretation based on standard curves).
7. The Type of Ground Truth Used
The "ground truth" for this substantial equivalence study is the results obtained from the predicate device, the DSL 10-1900 hGH ELISA. This predicate device is considered a validated method for measuring hGH.
8. The Sample Size for the Training Set
Not applicable. This document describes a method comparison study to demonstrate substantial equivalence, not the development or training of an AI algorithm or a machine learning model. Therefore, there is no "training set" in the context of AI/ML. All 68 samples were used for the comparison study.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set in the AI/ML sense.
§ 862.1370 Human growth hormone test system.
(a)
Identification. A human growth hormone test system is a device intended to measure the levels of human growth hormone in plasma. Human growth hormone measurements are used in the diagnosis and treatment of disorders involving the anterior lobe of the pituitary gland.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.