(199 days)
The Sentinel UIBC Liquid (Unsaturated Iron Binding Capacity) assay is intended to measure the unsaturated iron-binding capacity in serum and plasma. Iron-binding capacity measurements are used in the diagnosis and treatment of anemia. CFR 862.1415
The Sentinel UIBC Liquid described in this 510(k) submission is composed of reagents and standard, packaged and distributed in the same kit. The device is intended to be sold as an in vitro test for professional use. Serum is added to an alkaline buffer/reductant solution containing a known concentration of iron to saturate the available binding sites on transferrin. The iron that remains free after transferrin saturation is reduced to a ferrous state and then complexed by Ferene-S to form a stable complex, of which the color intensity is measured at 580-600nm. UIBC is therefore determined by subtracting the quantity of unbound iron from the total added quantity.
The document describes the Sentinel UIBC Liquid device and its comparison to a predicate device. Here's a breakdown of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria." However, it presents a method comparison study as evidence of performance. The implicit acceptance criterion for substantial equivalence is a strong correlation with the predicate device.
| Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Correlation (r) | High correlation with predicate | 0.9144 |
| Regression (y=mx+q) | Slope near 1, intercept near 0 | y = 1.024x + 14.64 |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 60 serum samples
- Data Provenance: Not explicitly stated, but it's a clinical evaluation of human serum samples, likely prospective for the purpose of the 510(k) submission. No country of origin is mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable and not provided in the document. For in vitro diagnostic devices like the Sentinel UIBC Liquid, "ground truth" is typically established by the results from a legally marketed predicate device, not by expert consensus in the same way it would be for image-based diagnostic AI.
4. Adjudication Method for the Test Set
Not applicable. The ground truth for this type of device is the measurement from the predicate device, not a subjective assessment 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
Not applicable. This document describes an in vitro diagnostic device for laboratory 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 assay, meaning its performance is inherently standalone (algorithm/reagent only). The method comparison study is effectively a standalone performance evaluation against a gold standard (the predicate device).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the performance evaluation was the results obtained from the predicate device (Roche UIBC). For this type of IVD, the predicate device's performance is considered the established method against which the new device is compared for substantial equivalence.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that requires a training set in the conventional sense. The device's performance is based on chemical principles and reagent formulations.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
§ 862.1415 Iron-binding capacity test system.
(a)
Identification. An iron-binding capacity test system is a device intended to measure iron-binding capacity in serum. Iron-binding capacity measurements are used in the diagnosis and treatment of anemia.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.