(160 days)
The Nichols Advantage® Chemiluminescence Soluble Transferrin Receptor Immunoassay is intended for use on the Nichols Advantage® Specialty System for the quantitative determination of Soluble Transferrin Receptor in human serum, EDTA and Heparin plasma as an adjunct in the diagnosis of Iron Deficiency Anaemia and for the differential diagnosis of Iron Deficiency Anaemia and Anaemia of Chronic Disease.
The Nichols Advantage® Soluble Transferrin Receptor Assay is a two-site chemiluminescence assay for use with the Nichols Advantage® Specialty System.
The provided text describes the 510(k) notification for the Nichols Advantage® Chemiluminescence Soluble Transferrin Receptor Immunoassay and its comparison to a predicate device. However, it does not include specific acceptance criteria, performance data, or details of a study designed to prove the device meets acceptance criteria. The document focuses on regulatory approval based on substantial equivalence.
Therefore, I cannot fulfill most of your request as the information is not present in the provided text.
Here's what can be extracted based on the information provided:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the text. The document doesn't state specific statistical acceptance criteria for accuracy, precision, or other performance metrics for the Nichols Advantage® assay. It only compares its characteristics (e.g., sensitivity, sample size, incubation) to the predicate device.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the text. There is no mention of a test set, sample size, or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the text. There is no mention of experts or ground truth establishment for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the text.
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 provided in the text. This device is an in-vitro diagnostic immunoassay, not an AI-assisted diagnostic tool for human readers, so an MRMC study in this context would not be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is a standalone immunoassay system. Its performance is determined by the assay itself, not an algorithm that assists a human. The text describes the device's characteristics and its equivalence to a predicate device, which implies standalone performance was evaluated for regulatory purposes. However, specific standalone performance data (e.g., accuracy, precision) against defined acceptance criteria is not provided. The "Sensitivity" listed in the table is a device characteristic, not necessarily a performance outcome against a clinical ground truth.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided in the text. For an immunoassay, the "ground truth" would typically refer to a gold standard method for measuring soluble transferrin receptor or clinical diagnoses against which the assay's results are validated. This is not detailed in the provided summary.
8. The sample size for the training set
This information is not provided in the text. Training sets are typically relevant for machine learning algorithms or for initial assay development/optimization. This document does not describe such studies.
9. How the ground truth for the training set was established
This information is not provided in the text.
§ 866.5880 Transferrin immunological test system.
(a)
Identification. A transferrin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the transferrin (an iron-binding and transporting serum protein) in serum, plasma, and other body fluids. Measurement of transferrin levels aids in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders, such as iron deficiency anemia.(b)
Classification. Class II (performance standards).