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The cassette COBAS Integra HDL-Cholesterol plus 2nd Generation contains an in vitro diagnostic reagent system intended for use on COBAS Integra systems for the quantitative determination of HDL-cholesterol concentration in serum and plasma. A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.

The HDL-Cholesterol plus 2nd Generation test principle uses magnesium sulfate and dextran sulfate to form water-soluble complexes with LDL, VLDL, and chylomicrons which are resistant to PEG-modified enzymes. The cholesterol concentration of HDL-cholesterol is determined enzymatically by cholesterol esterase and cholesterol oxidase coupled with PEG. The color intensity of the blue quinoneimine dye formed is directly proportional to the HDL-cholesterol concentration. It is determined by measuring the increase in absorbance at 583 nm.

The provided text does not contain detailed acceptance criteria, the study or performance data of the HDL-Cholesterol plus 2nd Generation device.

The document is a 510(k) summary and an FDA clearance letter, which primarily focuses on establishing substantial equivalence to a predicate device (Roche/Hitachi HDL-Cholesterol plus 2nd generation assay, K963213). It describes the device, its intended use, and indicates that it has the "same intended use and indication for use, the same scientific principle, the same formulation and similar application parameters" as the predicate device.

Therefore, I cannot provide the requested information, specifically:

1. A table of acceptance criteria and the reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts and their qualifications for ground truth.
4. Adjudication method for the test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done.
6. If a standalone performance study was done.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

This type of detailed performance data is typically found in the full 510(k) submission, specifically in the performance testing sections, which are not included in this summary document.

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