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The HDLC method is an in vitro diagnostic test for the quantitative measurement of high-density lipoprotein cholesterol (HDL-C) in human serum and plasma on the Dimension Vista® system. Measurements of HDL-C are used as an aid in the diagnosis of lipid disorders (such as diabetes mellitus), various liver and renal diseases and in the assessment of risk for atherosclerosis and cardiovascular disease.

Dimension Vista® HDCL Flex® reagent cartridge is a pre-packaged in-vitro diagnostic test method (assay) that is specifically designed to be used on the Dimension Vista® Integrated system, a floor model, fully automated microprocessor-controlled, integrated instrument system. The reagents contained in the Dimension Vista® Flex® reagent cartridges are the same as those manufactured for the Dimension® clinical chemistry analyzers. The packaging modification does not affect the fundamental scientific technology of the device. The HDLC assay measures serum HDL cholesterol levels directly without the need for sample pretreatment or separation steps, using a two reagent format. In the first reaction, lipoproteins are precipitated with dextran sulfate in the presence of magnesium sulfate. These complexes are resistant to the polyethylene glycol (PEG)-modified cholesterol esterase (CE) and cholesterol oxidase (CO) that react with HDL cholesterol. In the second reaction, in the presence of oxygen, the HDL cholesterol is oxidized to A-4-cholestenone and hydrogen peroxide. The generated hydrogen peroxide then reacts with 4-aminoantipyrine (4-AAP) and N-ethyl-N-(2-hydroxy-3-sulfopropyl)-3,5-dimethoxyaniline (HSDA) in the presence of peroxidase. The resulting quinoneimine dye is measured using a bichromatic (600/700 nm) technique. The color intensity of the dye is directly proportional to the serum HDL-C concentration.

Here's a breakdown of the acceptance criteria and study information based on the provided document:

Acceptance Criteria and Device Performance

The document doesn't explicitly state "acceptance criteria" with numerical targets in a formal table outside of the comparison, but it implies that the performance of the new device (Dimension Vista® HDLC Flex® reagent cartridge - K3408A) must be "substantially equivalent" to the predicate device (Dimension® AHDL Flex® reagent cartridge - K073072). The comparison table below highlights key identical features and performance aspects. The "Conclusion" section explicitly states that "Comparative testing also demonstrates substantially equivalent performance."

Table of Acceptance Criteria (Implied Equivalence) and Reported Device Performance:

Note on Differences (Not Acceptance Criteria but Design Changes):

• Reagents Cartridge: Predicate uses 6-well plastic Flex® cartridges; New device uses 12-well plastic Flex® cartridges.
• Total Tests per Cartridge: Predicate provides 30 tests; New device provides 120 tests.
• Sample Size: Predicate uses 3 µL; New device uses 1.3 µL.

Study Information:

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence rather than a detailed clinical trial report. As such, specific study details are limited.

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

   • The document states "Comparative testing also demonstrates substantially equivalent performance." However, it does not explicitly state the sample size used for this comparative testing or the data provenance (e.g., country of origin, retrospective/prospective).
   • Given the nature of an in-vitro diagnostic device for cholesterol measurement, it would typically involve human serum/plasma samples, but the specifics are not provided.

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

   • Not applicable/Not mentioned. For this type of in-vitro diagnostic device, ground truth is typically established through a reference method or comparison to a predicate device's established performance, rather than expert interpretation of results. The device and its predicate were "Evaluated by and met the certification criteria of the Cholesterol Reference Method Laboratory Network (CRMLN)," which implies adherence to a highly standardized and validated reference method for ground truth.

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

   • Not applicable/Not mentioned. Adjudication methods are typically used in imaging or clinical interpretation studies where there is subjective assessment. This is an IVD device measuring a quantitative analyte.

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 an in-vitro diagnostic device for quantitative measurement of High-Density Lipoprotein Cholesterol (HDL-C), not an AI-assisted diagnostic imaging or interpretation device that would involve human readers.

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

   • Yes, implicitly. The device itself is an automated assay system (Dimension Vista® Integrated system) designed for quantitative measurement. Its performance, as demonstrated by "comparative testing," refers to the algorithm's ability to accurately measure HDL-C concentrations on the new system compared to the predicate, in a standalone fashion without human intervention in the measurement process itself. Human involvement would be in operating the instrument and interpreting the numerical results, not in the direct measurement by the device.

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

   • The ground truth is established through adherence to the Cholesterol Reference Method Laboratory Network (CRMLN) certification criteria. This indicates that the device's measurements are traceable to a highly accurate and standardized reference method for cholesterol, which serves as the "gold standard" for quantitative cholesterol measurement.

7. The sample size for the training set:

   • Not applicable/Not mentioned. This device is not an AI/machine learning device that requires a separate "training set" in the conventional sense. It's a new formulation/packaging of an existing chemical reagent for a known analytical method. The development would involve analytical validation rather than machine learning training.

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

   • Not applicable. As noted above, there's no "training set" in the context of machine learning. The analytical performance (accuracy, precision) is validated against established reference methods (CRMLN).

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