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The Quantimetrix Lipoprint™ System LDL Subfractions is a device intended to measure lipoprotein cholesterol (for lipoprotein fractions and subfractions) in fasting serum or plasma with a Total Cholesterol concentration of ≥ 100 mg/dl. Lipoprotein cholesterol measurements are used as an aid in evaluating lipid metabolism disorders when used in conjunction with other lipid tests, patient risk assessment and clinical evaluation.

Quantimetrix is implementing an analysis software capability to the LipoPrint™ System LDL Subfractions. The software application is used in conjunction with commercially available hardware (computer, scanner and color printer) to analyze scanned tube images and generate characterizations of lipoprotein fractions and subfractions resolved by Lipoprint (VLDL, IDL, LDL, HDL).

The provided text is a 510(k) summary for the LipoPrint™ System LDL Subfractions, detailing its intended use and classification. However, it does not contain the specific information required to answer the question about acceptance criteria and the study proving the device meets those criteria.

The document states that Quantimetrix is implementing an analysis software capability to the LipoPrint™ System LDL Subfractions, and the modification was determined to be "moderate," concerning only the software. It also indicates that the intended use of the modified device remains the same as the unmodified device.

Therefore, crucial information such as acceptance criteria, reported performance, sample sizes, data provenance, expert qualifications, ground truth establishment, adjudication methods, multi-reader multi-case study details, or standalone algorithm performance are not present in the provided text.

Without this information, it is impossible to create the requested table and provide descriptions of the studies.

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