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Indication of serum and plasma bilirubin is useful in the screening of liver function disorders or in the diagnosis of jaundice.

Wako Total Bilirubin V is based on a chemical oxidation method, utilizing vanadate as an oxidating agent, shows good correlation with conventional methods, practically no interference by coexistent serum and plasma substances, and is convenient ready-to-use liquid type reagent. When a sample is mixed with the reagent containing the detergent and the vanadate, at around pH3, total bilirubin in the sample is oxidized to biliverdin. This causes the absorbance of yellow, specific to bilirubin, to decrease. Therefore, the total bilirubin concentration in the sample can be obtained by measuring the adsorbances before and after the vanadate oxidation.

This submission is for a reagent, the Wako Total Bilirubin V assay, and thus the acceptance criteria and study design are related to the analytical performance of the assay rather than a diagnostic device that requires expert consensus or advanced imaging.

Here's an analysis of the provided text in relation to your request:

Acceptance Criteria and Device Performance

The provided text does not explicitly state specific numerical acceptance criteria for the Wako Total Bilirubin V assay. Instead, it relies on demonstrating "substantial equivalency" to a previously marketed device (510(K) # 970985).

The reported device performance, in terms of meeting implicit acceptance criteria, is based on the following:

• Substantial Equivalency: The key claim is that "The safety and effectiveness of the Wako Total Bilirubin V assay is demonstrated by its substantial equivalency to our previous Total Bilirubin assay (510(K) # 970985)."
• Correlation with Conventional Methods: The device "[Wako Total Bilirubin V] shows good correlation with conventional methods."
• Interference by Coexistent Serum and Plasma Substances: It demonstrates "practically no interference by coexistent serum and plasma substances."
• Convenience and Stability: It is also "convenient ready-to-use liquid type reagent."

Table of Acceptance Criteria and Reported Device Performance (Inferred):

Study Details

Given the nature of the submission (510(k) for an in vitro diagnostic reagent, primarily adding a sample type), the study described is an analytical validation comparing the new device to a predicate and conventional methods. It is not a clinical study involving human readers or extensive ground truth establishment in the way a diagnostic imaging device would be studied.

1. Sample Size used for the test set and the data provenance:

   • Sample Size: Not explicitly stated in the provided text.
   • Data Provenance: Not explicitly stated, but typical for such submissions would be laboratory-based analytical studies using human serum and plasma samples. It does not specify country of origin or whether it's retrospective or prospective, but these are generally prospective analytical studies for IVD reagents.

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

   • Not applicable in the sense of expert human interpretation of images/data. The "ground truth" (or reference values) would be established by the "conventional methods" mentioned (diazo coupling, bilirubin oxidase enzymatic method) which are laboratory-based chemical analyses, often performed by trained medical technologists or clinical chemists. No specific number or qualifications of individual "experts" are provided as this is a chemical assay validation.

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

   • Not applicable. This is an analytical performance study of a chemical reagent, not a diagnostic interpretation study requiring adjudication of expert opinions.

4. 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 is not an AI-assisted diagnostic device, nor is it a study involving human readers.

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

   • This is inherently a "standalone" device in the sense that it is a chemical reagent that performs its function without a human-in-the-loop interpretative step once the sample is added. However, the term "standalone" usually refers to AI algorithms. In the context of IVDs, this refers to the assay's analytical performance on its own. The description implies such a standalone analytical validation was performed.

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

   • The "ground truth" for bilirubin measurement is established through reference laboratory methods, specifically the "conventional methods" like the diazo coupling method and the bilirubin oxidase enzymatic method, which are well-established chemical assays for bilirubin quantification.

7. The sample size for the training set:

   • Not applicable. This is a chemical reagent, not a machine learning algorithm that requires a "training set."

8. How the ground truth for the training set was established:

   • Not applicable. (See #7).

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