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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.

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.

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The Wako L-type UIBC test is an in vitro diagnostic assay for the quantitative determination of iron in serum. Measurement of serum iron concentration, UIBC and total iron binding capacity (TIBC) are is largely of use in the diagnosis of iron deficiency anemia, hemochromatosis, chronic inflammatory disorders and malignancies.

The Wako L-type UIBC is a method utilizing bathophenanthroline as a chromogen. When a sample is mixed with the Buffer containing a known excess amount of iron, unsaturated transferrin in serum quantitatively associates with iron in the Buffer and is converted to a saturated state. The portion of iron which remains unassociated is assayed through color development with ascorbic acid and bathophenanthroline disulfonic acid disdoium salt. The unsaturated transferrin concentration in the sample can be determiend by calculating the decrement of iron in the Buffer.

The provided text describes a 510(k) submission for the Wako L-type UIBC test, an in vitro diagnostic assay. The primary study proving the device meets acceptance criteria is a demonstration of its substantial equivalency to the Wako UIBC manual test.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

The document mentions "precision studies" and "substantial equivalency" but does not specify the sample size used for these tests. Data provenance (e.g., country of origin, retrospective or prospective) is also not explicitly stated.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document does not provide this information. The "ground truth" for the test appears to be the performance of the predicate device (Wako UIBC manual test) and various analytical performance characteristics.

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

The document does not describe any adjudication method for establishing ground truth, as it's an in vitro diagnostic assay and not a subjective image interpretation task.

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 MRMC study was performed or is relevant in this context. This is an in vitro diagnostic assay, not an AI-assisted diagnostic imaging device for human interpretation.

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

This refers to an in vitro diagnostic assay, which by nature operates as a "standalone" system in terms of producing a quantitative result from a sample. The device measures "unsaturated transferrin concentration in the sample" and then "determines...by calculating the decrement of iron in the Buffer." This suggests an automated or semi-automated process without a human-in-the-loop performance component beyond sample handling and result interpretation.

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

The ground truth for evaluating the Wako L-type UIBC assay is its analytical performance relative to a predicate device (Wako UIBC manual test) and established analytical standards (e.g., linearity, minimum detectable level, precision). The "truth" is based on the chemical measurement of UIBC.

8. The sample size for the training set

The document does not refer to a "training set" as this is not a machine learning or AI-based device in the common sense. It's a chemical diagnostic assay.

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

As there is no mention of a training set in the context of machine learning, this question is not applicable. The "ground truth" for the development of any chemical assay would be established through rigorous analytical chemistry principles and reference methods to ensure accurate measurement of the analyte.

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