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For use in clinical laboratories and physicians' office laboratories for quantitative determination of high density lipoprotein (HDL) cholesterol in human serum as a risk factor in coronary artery disease.

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This is a 510(k) Premarket Notification for the "RDI Homogeneous HDL Cholesterol Test", cleared in 1997. The available document is the FDA's clearance letter and the "Indications for Use" statement.

Unfortunately, this document does not contain the detailed study information required to answer your request about acceptance criteria and device performance.

The FDA 510(k) clearance process historically relies on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than requiring extensive clinical trials for efficacy and safety like a PMA (Premarket Approval) process. While a 510(k) submission typically includes performance data, that data is not included in the provided clearance letter.

Therefore, I cannot provide the specific details you asked for regarding:

1. A table of acceptance criteria and the reported device performance: This information is not in the clearance letter.
2. Sample size used for the test set and the data provenance: Not available in this document.
3. Number of experts used to establish the ground truth... and qualifications: Not available in this document.
4. Adjudication method: Not available in this document.
5. MRMC comparative effectiveness study results: Not applicable as this is not an AI/imaging device and this type of study is for comparing human readers with and without AI assistance.
6. Standalone performance: While the device has standalone performance (as a diagnostic test), the specific metrics are not detailed here.
7. Type of ground truth used: Not available in this document.
8. Sample size for the training set: Not applicable, as this is not an AI/machine learning device that requires a "training set" in the modern sense. It's a chemical assay.
9. How the ground truth for the training set was established: Not applicable.

The document only states the device's Indications For Use:
"For use in clinical laboratories and physicians' office laboratories for quantitative determination of high density lipoprotein (HDL) cholesterol in human serum as a risk factor in coronary artery disease."

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