Search Results

FOR IN VITRO DIAGNOSTIC USE.
The Transferrin SPQ™ III ANTIBODY REAGENT SET is designed for the quantitative determination of transferrin in human serum by immunoprecipitin analysis.

Transferrin (TRF) Immunological Test Kit

The provided document is a 510(k) summary for the Transferrin SPQ™ III Antibody Reagent Set, which is a modification of an existing device. It discusses the substantial equivalence to a predicate device rather than presenting a standalone study with acceptance criteria and detailed performance metrics. Therefore, many of the requested details about acceptance criteria, specific performance numbers, sample sizes, ground truth establishment, and expert involvement are not explicitly stated in the provided text.

Based on the information available:

1. A table of acceptance criteria and the reported device performance

The document does not provide a specific table of acceptance criteria with numerical targets. Instead, it states that the modified device was compared to a predicate device (Transferrin SPQ™ II Antibody Reagent Set) and found to be "substantially equivalent."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not specified in the provided document.
• Data Provenance: Not specified in the provided document. It is not mentioned whether the data was retrospective or prospective, nor the country of origin.

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)

Not applicable. The document describes an in vitro diagnostic device for quantitative determination of transferrin, not an imaging or diagnostic device that typically involves expert interpretation for ground truth establishment in a study of this nature. The "ground truth" for such a device would typically be established by a reference method or validated assays, not expert consensus on images.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation (e.g., radiology reads) to resolve discrepancies. This is an in vitro diagnostic device, and its performance is evaluated against chemical/biological measurements, not human consensus on visual findings.

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

Not applicable. An MRMC study is relevant for AI systems assisting human readers, typically in medical imaging. This document describes an in vitro diagnostic reagent set for chemical analysis, not an AI-assisted diagnostic tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is an in vitro diagnostic reagent set. Performance refers to the assay's ability to accurately measure transferrin levels. The "algorithm only" concept does not directly apply in the way it would for AI/software devices. The "standalone" performance would be the analytical performance of the assay itself (e.g., precision, accuracy, linearity, limit of detection), which is what "Nonclinical Testing" and "Clinical Testing" generally refer to for such devices. The document states that both nonclinical and clinical testing demonstrated substantial equivalence to the predicate device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The document does not explicitly state the type of ground truth used. For an in vitro diagnostic quantitative assay like this, "ground truth" would typically be established by:

• Reference method/assay: Comparing results to a recognized, highly accurate, and precise reference method for transferrin measurement.
• Calibrators and controls: Using materials with known transferrin concentrations.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set in that context. It is an in vitro diagnostic reagent set. The development involved modification of an existing reagent set, not training an algorithm.

9. How the ground truth for the training set was established

Not applicable, as there is no "training set" in the context of an AI/machine learning algorithm for this type of device.

Ask a specific question about this device