(46 days)
The Nichols Advantage® Chemiluminescence Cortisol Immunoassay is intended for use with the Nichols Advantage® Specialty System for the quantitative determination of cortisol concentration in human serum, EDTA plasma, and urine. Measurements of cortisol are used in the diagnosis and treatment of disorders of the adrenal gland.
The Nichols Advantage® Chemiluminescence Cortisol Immunoassay (hereinafter referred to as the Assay) is a Chemilumeniscence assay intended for use with the Nichols Advantage® Specialty System.
The provided text describes the Nichols Advantage® Chemiluminescence Cortisol Immunoassay. While it lists performance characteristics, it does not present a formal "acceptance criteria" table or a specific "study" with a comparative effectiveness design that would typically be seen for AI/ML devices. Instead, it details various analytical performance studies conducted to demonstrate the assay's suitability for its intended use and its substantial equivalence to a predicate device.
Here's an attempt to structure the information based on your request, highlighting where the provided text does not contain the requested details (especially for AI-specific questions):
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a tabular format for each specific test. However, it presents the results of several analytical performance studies, implying that these results met internal criteria for demonstrating the assay's performance.
| Performance Characteristic | Reported Device Performance |
|---|---|
| Reproducibility | Inter-assay precision: 8.6-10.3% CV |
| Recovery | Mean extraction recovery (spiked urine): 102% |
| Analytical recovery (mixed high/low cortisol samples): 98 ± 5% (mean ± SD) | |
| Linearity/Recovery | Linearity/recovery (diluted urine after extraction): 99 ± 9% (mean ± SD) |
| Extraction Efficiency | Mean extraction recovery (spiked urine): 102% (indicating efficient, complete, and reproducible extraction) |
| Parallelism | Mentioned as studied, but no specific quantitative result provided. |
| Effect of Interferents | No observed interference at pathological concentrations for protein, urea, creatinine, glucose, and sodium chloride. |
| Expected Values | Mentioned as studied for normal individuals, but no specific quantitative results provided. |
| Sensitivity | Sufficient to measure Cortisol found in patients with disorders of the adrenal gland. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes used for each specific test (reproducibility, recovery, interference, etc.). It describes the types of samples used (human serum, EDTA plasma, urine) but does not provide details on their provenance (e.g., country of origin, retrospective or prospective collection).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable as the device is a laboratory immunoassay for quantitative determination of cortisol, not an AI/ML device requiring expert interpretation of images or other complex data for ground truth establishment. The "ground truth" for this type of device is typically established through reference methods or known concentrations in spiked samples.
4. Adjudication Method for the Test Set:
This information is not applicable for a quantitative immunoassay. Adjudication methods like 2+1 or 3+1 are typically used for expert consensus in AI/ML performance evaluations, not for validating chemical assays.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI/ML devices where the AI is intended to assist human readers (e.g., radiologists interpreting images). This device is a standalone diagnostic assay.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
While the term "standalone" in the context of AI refers to the algorithm's performance without human intervention, in the context of this immunoassay, it inherently operates as "standalone" in the sense that it provides a quantitative result without requiring human interpretive intervention in the measurement process itself. The reported performance characteristics (reproducibility, recovery, etc.) reflect the device's inherent analytical capabilities.
7. The Type of Ground Truth Used:
The ground truth for this device (a quantitative immunoassay) is established through:
- Known concentrations: For spiked urine samples (e.g., to determine extraction recovery).
- Reference methods: Implicitly, the comparison to a predicate device (Nichols Advantage® Chemiluminescence Cortisol Assay K962208) suggests that the underlying principles and expected performance are aligned with established methods.
- Mixing experiments: For calculating analytical recovery.
8. The Sample Size for the Training Set:
This information is not applicable as this is not an AI/ML device that requires a "training set." The assay's performance is based on chemical and immunological principles, not on learned patterns from a training dataset.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the same reason as point 8.
§ 862.1205 Cortisol (hydrocortisone and hydroxycorticosterone) test system.
(a)
Identification. A cortisol (hydrocortisone and hydroxycorticosterone) test system is a device intended to measure the cortisol hormones secreted by the adrenal gland in plasma and urine. Measurements of cortisol are used in the diagnosis and treatment of disorders of the adrenal gland.(b)
Classification. Class II.