Search Results

The Wako Direct HDL-C test is an in vitro diagnostic assay for the quantitative determination of high density lipoprotein cholesterol in serum.

The Wako Direct HDL-C test eliminates the precipitation procedure by employing a specific antibody, and thus, can be applied on automated analyzers. Anti human β-lipoprotein antibody Reagent 1 binds to lipoproteins (LDL, VLDL, and chylomicrons) other than HDL. The antigen-antibody complexes formed block enzyme reactions when Reagent 2 is added. Cholesterol esterase (CHE) and cholesterol oxidase (CO) in Reagent 2 react only with HDL-C. Hydrogen peroxide produced by enzyme reactions with HDL-C yields a blue color complex upon condensation with FDAOS [N-ethyl-N- (2-hydroxy-3oxidase sulfopropyl)-3,5-dimethoxy-4-fluoroaniline, sodium salt] and 4aminoantipyrine (4AA) in the presence of peroxidase (POD). By measuring the absorbance of the blue color complex produced, at approximately 600 mm, the HDL-C concentration in the sample can be calculated when compared with the absorbance of the HDL-C Calibrator.

The provided text describes a medical device, the "Wako Direct HDL-C test," which is an in vitro diagnostic assay. It's not a device that uses AI or machine learning, nor does it involve image analysis or human readers. Therefore, many of the requested categories for AI/ML device studies are not applicable.

Below is an attempt to address the relevant points based on the provided text, recognizing the limitations of its scope concerning AI/ML criteria.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document mentions "comparison studies against the predicate assay" using "serum samples," but it does not specify the sample size for this test set. The data provenance (e.g., country of origin, retrospective/prospective) is also not specified.

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

This is not applicable as the device is an in vitro diagnostic assay and does not rely on expert interpretation to establish ground truth for a test set in the way an AI/ML diagnostic system would (e.g., for image analysis). The ground truth would be the actual HDL-C concentration measured by the predicate device.

4. Adjudication method for the test set

This is not applicable as the device is an in vitro diagnostic assay and does not involve adjudication of readings for a test set.

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 is not applicable. The Wako Direct HDL-C test is an automated diagnostic assay, 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

The entire study described is a standalone performance study of the diagnostic assay itself. It's an "algorithm only" in the sense of the chemical reactions and measurement principles. There is no human-in-the-loop performance component beyond the technician operating the automated analyzer.

7. The type of ground truth used

The ground truth for comparison was established by the predicate HDL-Cholesterol assay (510(k) # K801834). This means the values obtained from the predicate device served as the reference for determining the accuracy and substantial equivalency of the new Wako Direct HDL-C test.

8. The sample size for the training set

The concept of a "training set" as understood in machine learning is not applicable to this traditional in vitro diagnostic assay. The device operates based on established chemical reactions, not on data-driven learning.

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

As there is no "training set" in the context of an AI/ML device, this question is not applicable. The assay's chemical principles are inherent without requiring a data-driven training phase to establish its functionality.

Ask a specific question about this device