(59 days)
For the quantitative determination of free thyroxine (FT4) in serum using the Ciba Corning Automated Chemiluminescence Systems.
The Ciba Corning ASC FrT4 Immunoassay is a competitive immunoassay. FT4 in the-sample competes with the acridinium ester (AE-labeled T4 (Lite Reagent) for a limited amount of polyclonal rabbit anti-T4 antibody, which is covalently coupled to paramagnetic particles (solid phase). An indirect relationship exists between the FT4 in a sample and the relative light units (RLUs) detected.
Here's an analysis of the provided information, focusing on acceptance criteria and the study proving device performance:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Implied/Direct) | Reported Device Performance |
|---|---|---|
| Sensitivity | Minimum detectable concentration | 0.1 ng/dl |
| Upper detection limit | 11.0 ng/dl | |
| Accuracy | Correlation with reference method | r = 0.97 |
| Equation describing correlation | ACS FrT4 = 1.06 (RIA) - 0.33 | |
| Precision | Total % CV | 2.81 to 4.65 |
Note: The document
does not explicitly state "acceptance criteria" but rather presents performance data. The table infers acceptance criteria based on the reported performance being considered acceptable for submission.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Accuracy Test: 74 samples.
- Data Provenance: Not specified (country of origin, retrospective or prospective).
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 document. The "ground truth" for the accuracy study appears to be a "RIA reference method assay," not expert adjudication.
4. Adjudication Method for the Test Set
This information is not applicable/not provided. The accuracy was assessed by comparing the device's results to an "RIA reference method assay," not through human 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 device is an in-vitro diagnostic immunoassay, not an AI-assisted diagnostic imaging device that involves human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
Yes, a standalone performance evaluation was done. The entire "Performance Data" section describes the quantitative output of the device itself (sensitivity, accuracy against a reference method, and precision) without involving a human in the loop for interpreting the results in a diagnostic context.
7. The Type of Ground Truth Used
The ground truth used for the accuracy assessment was a reference method assay, specifically an "RIA reference method assay."
8. The Sample Size for the Training Set
This information is not provided in the document. The document describes studies to validate the performance of the device, not the training of a machine learning model.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/not provided. The device described is an immunoassay, not a machine learning model that requires a training set and corresponding ground truth.
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.