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The ATAC Direct LDL Reagent Kit, the ATAC Direct LDL Calibrator and the ATAC 8000 Random Access Chemistry System are intended for the quantitative determination of LDL-cholesterol in serum and plasma. LDL-cholesterol measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases, and for the assessment of the risk of developing cardiovascular disease.

The ATAC Direct LDL Reagent determines LDL-cholesterol through a two step reaction, which specifically consumes non-LDL cholesterol in a series of reactions without producing color. In the second reaction step, the chromogen is added, and a second detergent solubilizes the LDL-cholesterol, allowing it to react with cholesterol oxidase, cholesterol esterase and peroxidase in the reagent to produce a color that is proportional to the amount of LDL-cholesterol in the sample.

Here's a breakdown of the acceptance criteria and the study details for the ATAC Direct LDL Reagent Kit, ATAC Direct LDL Calibrator, and ATAC 8000 Random Access Chemistry System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Sizes Used for the Test Set and Data Provenance

• Linearity Study: n = 35 (number of standard factors, implicitly indicating the number of samples used to establish linearity)
• Precision Study:
  • Serum 1: n = 60
  • Serum 2: n = 60
  • Serum 3: n = 59
• Comparison to Competitive Reagent: n = 159 (mixed serum and plasma specimens from adult patients)
• Accuracy (Comparison to Beta-Quantification Reference Method): n = 42 (serum and plasma specimens from 22 adults)
• Detection Limit Study: 30 replicates of a diluted serum pool.

Data Provenance: The text states, "Mixed serum and plasma specimens, collected from adult patients," and "42 serum and plasma specimens, collected from 22 adults." This indicates the data is from human patients. While the specific country of origin is not explicitly stated, the submission is to the US FDA, implying testing relevant to that regulatory body, likely involving US-based studies. The studies are prospective in nature, as they involve performing assays to determine the device's performance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This device is an in vitro diagnostic for measuring a chemical analyte (LDL-cholesterol). The "ground truth" is established by standard laboratory reference methods or highly-regarded comparative methods, not by expert interpretation of images or other subjective assessments.

• For "Accuracy" studies: The ground truth was established by the beta-quantification reference method.
• For "Comparison" studies: The ground truth was established by a "commercially available method" (another LDL-cholesterol assay).

Therefore, there were no human "experts" in the sense of clinicians or radiologists establishing ground truth. The "experts" are the established and validated laboratory methodologies.

4. Adjudication Method for the Test Set

Not applicable for this type of in vitro diagnostic device study. Adjudication methods (like 2+1, 3+1) are typically used for studies where multiple human readers interpret data (e.g., medical images) and their interpretations need to be reconciled to form a ground truth. Here, the ground truth is determined by objective chemical or reference methods.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

No. An MRMC study is not relevant for this type of in vitro diagnostic device. This device measures an analyte; it's not an imaging or diagnostic tool where human readers interpret outputs.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)

Yes, the studies directly assess the "standalone" performance of the ATAC Direct LDL Reagent Kit and the ATAC Direct LDL Calibrator used on the ATAC 8000 Random Access Chemistry System. The reported performance metrics (linearity, precision, correlation, accuracy, detection limit, stability) are all measurements of the device's inherent capability, without human intervention in the analytical measurement process itself. The "human-in-the-loop" would be the laboratory personnel operating the system and interpreting the quantitative numerical results, but the performance data presented here are for the device alone.

7. Type of Ground Truth Used

The ground truth used in the studies includes:

• Reference Method: Beta-quantification method (for accuracy assessment). This is a highly accurate and established method for measuring LDL-C.
• Comparative Commercial Method: Another commercially available LDL-cholesterol assay (for method comparison).
• Standard Factors: Pre-defined concentrations of LDL-cholesterol (for linearity assessment).
• Commercially Available Control Serum / Serum Pool: Materials with known or expected LDL-C values (for precision assessment).

8. Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of machine learning or AI. This device is a chemical reagent and an automated chemistry analyzer, not an AI/ML algorithm that requires training data in the typical sense. It relies on chemical reactions and photometric detection calibrated against known standards.

9. How the Ground Truth for the Training Set Was Established

As there is no "training set" in the AI/ML sense for this type of device, this question is not applicable. The device's operational parameters and calibration are established using defined standards and controls, as outlined in the linearity and stability studies, which serve a similar function to "training" in ensuring the device performs correctly.

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