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LDL-cholesterol test system is a device to measure LDL-cholesterol in serum. LDL-Cholesterol measurements are used in diagnosis and treatment of disorders of excess cholesterol in the blood and lipid and lipoprotein metabolisms disorders.

The Wako Direct LDL-C test is an in vitro diagnostic assay for the quantitative determination of low density lipoprotein cholesterol in serum.

Here's an analysis of the provided text to extract the requested information about the Wako Direct LDL-C test:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the comparison to a predicate device and a reference method. The key performance metrics are correlation coefficients and regression equations.

• Serum samples: Correlation coefficient = 0.986; Regression equation (y = Wako Direct LDL-C, x = Predicate) = 1.018x + 0.135
• Plasma samples: Correlation coefficient = 0.988; Regression equation (y = Wako Direct LDL-C, x = Predicate) = 0.98x + 4.18 |
  | Performance against reference method ("beta quantification" involving ultracentrifugation) |
• Serum samples: Correlation coefficient = 0.983; Regression equation (y = Wako Direct LDL-C, x = Reference) = 0.97x + 5.12 |
  | Precision | "Precision studies indicate acceptable values can be obtained on a day to day basis." (No specific quantitative criteria or results provided beyond this statement). |
  | Minimum detectable level | 1 mg/dL |

2. Sample Sizes and Data Provenance

The document does not explicitly state the sample sizes used for the comparison studies (test set). It mentions "serum and plasma samples" for predicate comparison and "serum samples" for reference method comparison, but no specific number of samples.

The data provenance (country of origin, retrospective/prospective) is also not mentioned.

3. Number of Experts and Qualifications for Ground Truth Establishment

This information is not provided. The study relies on comparisons to a predicate device and a "reference method" (beta quantification), which are themselves laboratory procedures, not expert visual assessments.

4. Adjudication Method for the Test Set

Not applicable. This is a laboratory assay, not a study involving human interpretation that would require adjudication.

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

No, an MRMC study was not done. This type of study is typically for evaluating devices that assist human readers in interpreting images or other data, which is not the function of this direct LDL-C measurement assay.

6. Standalone (Algorithm Only) Performance

Yes, the studies described are standalone performance studies. The Wako Direct LDL-C test is an automated in vitro diagnostic assay that directly measures LDL-C in a sample. Its performance is evaluated independently against a predicate device and a reference method. There is no human-in-the-loop component for the measurement itself.

7. Type of Ground Truth Used

The ground truth for the comparison studies was:

• Predicate Device Performance: The results obtained from the "Equal LDL Direct Liquid Select Cholesterol reagent."
• Reference Method Performance: The results obtained from the "beta quantification" method, which involves ultracentrifugation. This is generally considered the gold standard laboratory method for LDL-C.

8. Sample Size for the Training Set

The document does not mention a separate "training set" or "training data." This device is a biochemical assay, not a machine learning algorithm that typically requires a distinct training phase. The development of the assay itself would have involved extensive R&D and optimization, but those details are not part of this 510(k) summary.

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

As there's no explicitly mentioned "training set" in the context of a machine learning algorithm, this question is not directly applicable. If one considers the development and optimization of the assay, the "ground truth" during that phase would have involved established chemical and biochemical principles, validation against known standards, and potentially experiments comparing early versions of the assay to existing methods (like the Friedwald formula or beta quantification). However, the document does not detail this developmental process.

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