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These products are to be used for the quantitative determination of apolipoprotein A1 and apolipoprotein B in human serum by immunoturbidimetric analysis. The determination of apolipoprotein A1 and apolipoprotein B are commonly performed as an aid in the assessment of individuals who are at risk for developing coronary artery disease.

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The provided text is a clearance letter from the FDA for an in vitro diagnostic device, specifically for Apolipoprotein A1 and Apolipoprotein B reagents and calibrators. This document is a regulatory approval and does not contain the information requested regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert qualifications for a device performance study.

The letter states that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory compliance requirements. It does not include data from a specific performance study.

Therefore, I cannot fulfill your request using the provided text. To answer your questions, I would need a document detailing the actual performance study conducted for the device's clearance.

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The Apolipoprotein A1 assay is used for the quantitation of apolipoprotein A1 in human serum or plasma. Measurement of A lipoproteins, the major proteins found in HDL (high density lipoprotein), is used in the diagnosis and treatment of premature coronary artery disease, hyper-a-lipoproteinemia, and hypo-α-lipoproteinemia.

Apolipoprotein A1 is an in vitro diagnostic assay for the quantitative determination of apolipoprotein A1 in human serum or plasma. Antibodies to apolipoprotein A1 combine with apolipoprotein A1 in the sample to form insoluble immune complexes. The immune complexes cause an increase in light scattering (turbidity). The resulting increase in sample turbidity, measured at 804 nm, is directly proportional to the concentration of apolipoprotein A1 in the sample.

This document describes the validation of an in vitro diagnostic assay for Apolipoprotein A1.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample sizes used for the test set and data provenance:

   • Test Set Sample Size: Not explicitly stated for method correlation. Precision studies were conducted using two levels of control material, but the number of unique samples or runs is not specified.
   • Data Provenance: Not explicitly stated, but typically these studies are conducted by the manufacturer at their facilities. No information on country of origin or retrospective/prospective nature is provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable. This is an in vitro diagnostic device for quantitative measurement, and "ground truth" is established through comparison with a legally marketed predicate device using quantitative performance metrics rather than expert consensus on interpretive tasks.

4. Adjudication method for the test set:

   • Not applicable. The "ground truth" for the test set is derived from the objective measurements obtained from the predicate device (for method correlation) and the device itself (for precision and sensitivity). There is no human adjudication process involved as would be for diagnostic image interpretation.

5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done:

   • No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging devices where human readers interpret medical images, and the AI system acts as an assist. This submission is for an in vitro diagnostic assay with quantitative results.

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

   • Yes, the performance characteristics described (method correlation, precision, assay range, sensitivity) represent the standalone performance of the Apolipoprotein A1 assay on the AEROSET™ System. There is no human-in-the-loop component for the measurement and reporting of Apolipoprotein A1 levels by this automated assay.

7. The type of ground truth used:

   • For method correlation, the "ground truth" was the quantitative results obtained from the predicate device (K-ASSAY® Apo A1 on the Hitachi® 717 Analyzer). The new device's measurements were compared against these established measurements.
   • For precision and sensitivity, the "ground truth" refers to the inherent performance characteristics of the assay itself, demonstrating its consistency and lower detection limit.

8. The sample size for the training set:

   • Not applicable. This is a submission for an in vitro diagnostic chemistry assay, not a machine learning or AI algorithm that requires a separate training set. The assay's performance is based on its chemical and immunological principles, reagents, and instrument calibration, not on data-driven training in the sense of AI.

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

   • Not applicable, as there is no training set in the context of a machine learning algorithm for this type of device. The assay's analytical performance is developed and optimized through standard laboratory practices, reagent formulation, and instrument design.

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