(27 days)
The DSL Active hGH ELISA Kit was developed for the quantitative measurement of human growth hormone in human serum. The measurement of growth hormone in serum is used as a diagnostic aid in the evaluation of hGH deficiency disorders or acromegaly.
Mouse monoclonal antibody "capture antibody" is immobilized to the inner surface of microtiter plate wells. Growth hormone in the standards or serum samples is "sandwiched" between the capture antibody and the anti-hGH monoclonal antibody conjugated to horseradish peroxidase enzyme.
This document is a "SUMMARY OF SAFETY AND EFFECTIVENESS" for a diagnostic device, specifically the "DSL 10-1900 hGH ELISA Kit". It describes the device, its intended use, and a study comparing it to a predicate device to demonstrate substantial equivalence.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a quantitative format for the new device's performance. Instead, it compares the new device to a predicate device (Nichols Institute hGH IRMA) to show "substantial equivalence." The reported performance relates to this comparison.
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance (Comparison to Nichols Institute hGH IRMA) |
|---|---|
| Strong linear correlation with predicate device | Regression analysis: Y = 1.06X + 0.25 |
| High correlation coefficient with predicate device | Correlation coefficient: 0.99 |
| Similar intended use as predicate device | "These kits have the same intended use." |
2. Sample size used for the test set and the data provenance
- Sample Size: 41 patient samples
- Data Provenance: The document does not specify the country of origin. It states "patient samples were collected," implying they are retrospective or a convenience sample collected specifically for the study. It doesn't indicate if they were collected prospectively.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. For an ELISA kit, "ground truth" would typically be established by laboratory reference methods or expert clinical interpretation of patient conditions, but the text focuses on comparing the new ELISA to another established ELISA.
4. Adjudication method for the test set
This information is not provided in the document, as the study is a direct comparison of two assays rather than a human-reader-based assessment requiring adjudication.
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
No, an MRMC comparative effectiveness study was not done. This document describes an in-vitro diagnostic (IVD) device (ELISA kit) for measuring a biomarker, not an AI or imaging device that would typically involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
The entire study described is a standalone performance of the DSL hGH ELISA kit compared to the Nichols Institute hGH IRMA kit. Both are automated or semi-automated laboratory assays, not requiring human "in-the-loop" interpretation in the same way an AI imaging algorithm might.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document implies that the Nichols Institute hGH IRMA served as the de-facto "ground truth" or reference method against which the new DSL hGH ELISA Kit was compared to establish substantial equivalence. It's a comparison against an existing, presumably validated, diagnostic assay.
8. The sample size for the training set
This information is not provided in the document. For an ELISA kit, training would typically involve assay development and optimization (e.g., reagent concentrations, incubation times), not a "training set" in the machine learning sense. The 41 samples discussed are for the equivalence comparison, not for training.
9. How the ground truth for the training set was established
This information is not applicable as there is no mention of a "training set" or "ground truth" for it in the context of this ELISA kit's development and validation in this document. The "ground truth" concept applies more directly to the comparison study described in point 7.
§ 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.