(23 days)
The intended use of this product is the quantitative determination of ACTH [Adrenocorticotropic Hormone] in human EDTA plasma. This immunoassay is based on the principles of the two site "sandwich" Enzyme-Linked ImmunoSorbent Assay (ELISA).
Quantitative determination of ACTH in human EDTA plasma. This immunoassay is based on the principles of the two site "sandwich" Enzyme-Linked ImmunoSorbent Assay (ELISA).
The provided text describes the Sangui BioTech, Inc. ACTH ELISA kit and its substantial equivalence to a predicate device. The information primarily focuses on the device's technical characteristics and the study conducted to demonstrate its performance.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based solely on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criterion, though not explicitly stated as a numerical threshold in the document, is implied by the goal of demonstrating substantial equivalency to the predicate device. The primary performance metric used to establish this is the correlation coefficient (R) between the proposed device and the predicate device.
| Acceptance Criteria | Numerical Target (Implied by Substantial Equivalency) | Reported Device Performance |
|---|---|---|
| Correlation (R) | High correlation (close to 1) between proposed device and predicate device | 0.995 |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: One hundred seventeen (117) patient plasma samples.
- Data Provenance:
- Country of Origin: Not specified in the provided text.
- Retrospective or Prospective: Not specified in the provided text. It is simply stated that "patient plasma analyzed using both the proposed device and the predicate device."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the text. The study compares the proposed device's performance against a "predicate device" (Nichols Institute Diagnostics ACTH Radioisotopic Assay), not against a 'ground truth' established by human experts in the traditional sense of a diagnostic interpretation study. The predicate device's results are effectively the reference standard in this comparison.
4. Adjudication Method for the Test Set
This information is not applicable/not provided in the context of this type of study. The study compares quantitative results from two devices, not subjective interpretations 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
This information is not applicable/not provided. The study is a comparison of two in vitro diagnostic (IVD) kits, not an AI-assisted diagnostic imaging or interpretation study involving human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This study is inherently a standalone performance assessment of the device (an ELISA kit) as it's an in vitro diagnostic test. The device itself performs the quantitative determination; there is no human-in-the-loop component for the device's operation in the context of this evaluation. The comparison is between two automated assay systems.
7. The Type of Ground Truth Used
In this context, the "ground truth" or reference standard for comparison is the results obtained from the predicate device: Nichols Institute Diagnostics ACTH Radioisotopic Assay. The data used for comparison ranged from 1.5 to 1,045 pg/mL of ACTH as measured by the predicate device.
8. The Sample Size for the Training Set
This information is not provided and is generally not applicable to the evaluation of an ELISA kit in the same way it would be for a machine learning algorithm. An ELISA kit is a biochemical assay, not an algorithm that requires a "training set" to learn from data.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no "training set" for an ELISA kit in the context of its development and validation.
§ 862.1025 Adrenocorticotropic hormone (ACTH) test system.
(a)
Identification. An adrenocorticotropic hormone (ACTH) test system is a device intended to measure adrenocorticotropic hormone in plasma and serum. ACTH measurements are used in the differential diagnosis and treatment of certain disorders of the adrenal glands such as Cushing's syndrome, adrenocortical insufficiency, and the ectopic ACTH syndrome.(b)
Classification. Class II.