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The TRIG test within the VITROS XT Chemistry Products TRIG-CHOL Slides quantitatively measure triglyceride (TRIG) concentration in serum and plasma using VITROS XT 7600 Integrated Systems. Triglyceride measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver diseases involving lipid metabolism, or various endocrine disorders.

The CHOL test within the VITROS XT Chemistry Products TRIG-CHOL Slides quantitatively measure cholesterol (CHOL) concentration in serum and plasma using VITROS XT 7600 Integrated Systems. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders mellitus), atherosclerosis, and various liver and renal diseases.

The new device, the VITROS XT Chemistry Products TRIG-CHOL Slide is a single device that contains both a TRIG test and a CHOL test multilayered, analytical elements coated on a polyester support separated by a plastic barrier sealed within a single slide frame. In this format, individual reactions occur and test results are generated for each analyte independently of the other analyte.

To perform the TRIG test, a drop of patient sample is deposited on the slide and is evenly distributed by the spreading layer to the underlying layers. The Triton X-100 surfactant in the spreading layer aids in dissociating the triglycerides from lipoprotein complexes present in the sample. The triglyceride molecules are then hydrolyzed by lipase to yield glycerol and fatty acids. Glycerol diffuses to the reagent layer, where it is phosphorylated by glycerol kinase in the presence of adenosine triphosphate (ATP). In the presence of L-a-glycerolphosphate oxidase, L-α-glycerophosphate is then oxidized to dihydrox vacetone phosphate and hydrogen peroxide. The final reaction involves the oxidation of a leuco dye by hydrogen peroxide, catalyzed by peroxidase, to produce a dye. The density of the dye formed is proportional to the triglyceride concentration present in the sample and is measured by reflectance spectrophotometry.

To perform the CHOL test, a drop of patient sample is deposited on the slide and is evenly distributed by the spreading layer to the underlying layers. The Triton X-100 (TX100) surfactant in the spreading layer aids in dissociating the cholesterol and cholesterol esters from lipoprotein complexes present in the sample. Hydrolysis of the cholesterol esters to cholesterol is catalyzed by cholesterol ester hydrolase. Free cholesterol is then oxidized in the presence of cholesterol oxidase to form cholestenone and hydrogen peroxide. Finally, hydrogen peroxide oxidizes a leuco dye in the presence of peroxidase to generate a colored dye. The density of dye formed is proportional to the cholesterol concentration present in the sample and is measured by reflectance spectrophotometry.

The provided text describes the analytical performance of the VITROS XT Chemistry Products TRIG-CHOL Slides, an in vitro diagnostic device for quantitatively measuring triglyceride (TRIG) and cholesterol (CHOL) concentrations in serum and plasma.

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

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

The document does not explicitly present a table of "acceptance criteria" but rather reports the analytical performance of the new device and shows its comparison to the predicate devices. The implicit acceptance criteria are that the new device performs at least as well as, and is substantially equivalent to, the predicate devices. The reported performance metrics are detailed in the tables for method comparison, precision, detection capability, and linearity.

TRIG Test

CHOL Test

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

• Method Comparison: 148 serum samples were used for both TRIG and CHOL tests.
• Precision: 80 observations (2 replicates per run, 2 runs per day over 20 days) for serum samples (patient pools and quality control materials).
• Detection Capability (LoQ): 180 determinations for both TRIG and CHOL.
• Linearity: Eighteen proportionally related admixtures of low and high test fluids, each tested in quadruplicate.

The data provenance is not explicitly stated in terms of country of origin or whether the samples were retrospective or prospective. It implies the use of patient samples, but specific details are absent.

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

This document describes the analytical performance of an in vitro diagnostic device, not a device that relies on expert human interpretation for its output (like an AI imaging device). Therefore, there is no mention of "experts used to establish the ground truth" in the way it would apply to a clinical imaging study or a study validating human performance. The "ground truth" for this type of device is established by its quantitative measurements against established analytical standards and reference methods/predicate devices.

4. Adjudication method for the test set

Not applicable. As noted above, this is an analytical performance study for an in vitro diagnostic device, not a human reader study 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 is an analytical performance study of an in vitro diagnostic device, not an AI-assisted diagnostic tool that would involve human readers.

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

Yes, this entire study represents a "standalone" performance evaluation of the device (VITROS XT Chemistry Products TRIG-CHOL Slides on the VITROS XT 7600 Integrated System) without human intervention in the result generation. The device quantitatively measures the analytes.

7. The type of ground truth used

The ground truth for this in vitro diagnostic device is established through:

• Comparison to a legally marketed predicate device: The VITROS Chemistry Products TRIG Slides and VITROS Chemistry Products CHOL Slides. This implies that the predicate devices serve as the established reference standard for performance.
• Established analytical methods and materials: CLSI protocols (EP09c, EP05-A3, EP17-A2, EP06-A, EP07-03) are referenced, which dictate the methodology for evaluating analytical performance parameters.
• Quality Control Materials and reference pools: Used in precision and linearity studies.
• Clinically established guidelines: NCEP guidelines are referenced for expected values/classification of TRIG and CHOL, indicating alignment with clinical understanding of these analytes.

8. The sample size for the training set

This document describes pre-market validation studies for a diagnostic test kit and instrument system. It does not refer to a "training set" in the context of machine learning or AI. The development of such a device involves internal optimization and development work, but the data presented in this 510(k) summary are for the validation of the finalized product.

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

Not applicable, as this refers to a diagnostic test kit and instrument's analytical validation, not an AI or machine learning model that would involve a "training set" with ground truth established through expert annotation.

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