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For the direct, quantitative determination of low-density lipoprotein cholesterol (LDL-C) in human serum or plasma.

The Boehringer Mannheim Direct LDL-Cholesterol test uses detergent and a sugar compound to inhibit reaction of VLDL, HDL and chylomicrons. The remaining LDL-Cholesterol is quantitatively measured with cholesterol esterase, cholesterol oxidase, and 4-aminoantipyrin.

This document is a 510(k) Pre-Market Notification for the Boehringer Mannheim Direct LDL-Cholesterol test. It establishes substantial equivalence by comparing it to a predicate device, the Equal Diagnostics LDL Direct Liquid Select™ Cholesterol Test, and does not provide detailed acceptance criteria or a comprehensive study report with the specific information requested.

Here's an analysis based on the provided text, highlighting what is present and what is missing:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state formal acceptance criteria in a table format. It focuses on demonstrating "substantial equivalence" to a predicate device.
However, it does mention "Specific data on the performance of the test have been incorporated into the draft labeling in Attachment 5." This attachment is not provided in the input, so the detailed performance characteristics and how they meet any implicit or explicit criteria are not available here.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the given text.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the given text. For an in vitro diagnostic (IVD) device measuring a biomarker, "ground truth" would typically refer to a validated reference method for LDL-C measurement rather than expert interpretation of images or clinical cases.

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

This information is not provided in the given text. Adjudication methods are typically relevant for interpretive tasks where multiple human readers are involved in establishing ground truth, which is not the primary focus of validating a quantitative IVD device.

5. 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

An MRMC study is not applicable and was not performed for this type of device. This device is a quantitative in vitro diagnostic test for LDL-Cholesterol, not an imaging-based AI system that assists human readers.

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

Yes, this device is a standalone test. The Boehringer Mannheim Direct LDL-Cholesterol test quantitatively measures LDL-C in serum and plasma using a chemical reaction. Its performance is evaluated intrinsically through analytical studies (e.g., accuracy, precision, linearity, interference) rather than through comparison to human interpretation. The provided text states: "The Boehringer Mannheim Direct LDL-Cholesterol test uses detergent and a sugar compound to inhibit reaction of VLDL, HDL and chylomicrons. The remaining LDL-Cholesterol is quantitatively measured with cholesterol esterase, cholesterol oxidase, and 4-aminoantipyrin." This describes an entirely automated analytical process.

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

For a quantitative diagnostic test like this, the ground truth would typically be established using a reference method or a gold standard method for LDL-C measurement. The specific reference method used for comparison is not explicitly stated in the provided text. However, to demonstrate substantial equivalence, the device's measurements would have been compared against a clinically accepted method for LDL-C.

8. The sample size for the training set

This information is not applicable and not provided. This device is a chemical reagent-based diagnostic test, not an AI/ML algorithm that requires a "training set" in the conventional sense. Its "training" is in the formulation and optimization of the reagents.

9. How the ground truth for the training set was established

This information is not applicable and not provided for the reasons stated above.

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