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For the quantitative determination of high density lipoprotein fractions of cholesterol in serum. For IN VITRO diagnostic use. A lipoprotein test system is a device intended to measure lipoprotein in serum. High Density Lipoprotein (HDL) cholesterol measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.

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This document is a 510(k) clearance letter for a medical device called the "HDL-ADVANCE Assay." While it confirms FDA clearance based on substantial equivalence to a predicate device, it does not contain the detailed study information, acceptance criteria, or performance data typically found in a full submission.

Therefore, I cannot extract the specific information requested in your prompt regarding acceptance criteria and the study proving the device meets those criteria from this document alone.

Here's what I can tell you based on the provided text, and where the requested information would typically be found in a full 510(k) submission:

Information NOT available in this document:

1. A table of acceptance criteria and the reported device performance: This letter only states that the device is "substantially equivalent" to legally marketed predicate devices. It does not provide the specific performance data (e.g., accuracy, precision, linearity, analytical sensitivity, specificity) or the acceptance criteria used to assess it. This information would be found in the "Performance Characteristics" section of a detailed 510(k) submission.
2. Sample size used for the test set and the data provenance: Not available. This would be part of the study design details in the performance data section.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for an in vitro diagnostic (IVD) test for a biomarker. Ground truth for an IVD like an HDL assay is typically established through reference methods or gold standard assays, not expert consensus on images or outcomes.
4. Adjudication method for the test set: Not applicable for an IVD for a biomarker.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. MRMC studies are typically used for imaging devices where human interpretation is involved.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable for an IVD assay. The "device performance" refers to the analytical performance of the assay itself.
7. The type of ground truth used: While not explicitly stated, for an HDL assay, the ground truth would typically be established using a recognized reference method for cholesterol or lipoprotein quantification, or by comparing it to an established, FDA-cleared predicate device.
8. The sample size for the training set: Not available. For an IVD, "training set" might refer to samples used for method development, calibration, or establishing reference ranges, rather than an ML-specific training set.
9. How the ground truth for the training set was established: Not available, but similar to point 7 above, it would involve reference methods or predicate devices.

What this document does tell us:

• Device Name: HDL-ADVANCE Assay, Cat. No. 278-20, 278-50A, 278-50B
• Intended Use/Indications for Use: For the quantitative determination of high density lipoprotein fractions of cholesterol in serum. For IN VITRO diagnostic use. HDL cholesterol measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.
• Regulatory Class: Class I (general controls)
• Predicate Device: The substantial equivalence determination is made "to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976." The specific predicate device(s) are not identified in this letter, but would be in the full submission.

To get the information you are looking for, you would need to access the full 510(k) submission (K041928), which contains the detailed analytical performance data and studies.

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