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The SYNCHRON® Systems Direct LDL Cholesterol (LDLD) Reagent, when used in conjunction with the SYNCHRON® Systems LDLD Calibrator, is intended for the quantitative determination of low-density lipoprotein cholesterol (LDL cholesterol) in human serum or plasma on SYNCHRON Clinical Systems.

The SYNCHRON System Direct LDL Cholesterol (LDLD) Reagent is designed for optimal performance on the SYNCHRON CX (CX4/4CE/4J/4PRO, CX5/5CE/5Δ/5PRO, CX7/7RTS/7/7/7PRO, CX9ALX/9PRO) and LX (LX20/PRO) Systems. The assay is intended for use in the quantitative determination of low-density lipoprotein cholesterol concentration in human serum or plasma. The reagent kit contains two 100-test cartridges and is packaged with the single-level calibrator.

{
  "1. A table of acceptance criteria and the reported device performance": {
    "Acceptance Criteria": null,
    "Reported Device Performance": {
      "Method Comparison Study Results (SYNCHRON LX Systems vs. Genzyme N-Geneous on Hitachi 911)": {
        "Range of LDL cholesterol analyzed": "52 to 192 mg/dL",
        "Equation": {
          "SYNCHRON = ": "1.200 * N-Geneous"
        }
      },
      "Estimated SYNCHRON LX LDLD Assay Imprecision": {
        "Within-Run Imprecision": {
          "Level 1 (Mean 49.9 mg/dL)": {
            "S.D. (mg/dL)": "2.2",
            "%C.V.": "nil"
          },
          "Level 2 (Mean 211.9 mg/dL)": {
            "S.D. (mg/dL)": "2.9",
            "%C.V.": "1.4"
          },
          "Level 3 (Mean 410.4 mg/dL)": {
            "S.D. (mg/dL)": "5.0",
            "%C.V.": "1.2"
          }
        },
        "Total Imprecision": {
          "Level 1 (Mean 49.9 mg/dL)": {
            "S.D. (mg/dL)": "1.4",
            "%C.V.": "2.9"
          },
          "Level 2 (Mean 211.9 mg/dL)": {
            "S.D. (mg/dL)": "3.8",
            "%C.V.": "1.8"
          },
          "Level 3 (Mean 410.4 mg/dL)": {
            "S.D. (mg/dL)": "6.7",
            "%C.V.": "1.6"
          }
        }
      }
    }
  },
  "2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)": {
    "Sample Size (for Imprecision Study)": "80 samples per level (Levels 1, 2, and 3)",
    "Data Provenance": "Not specified (neither country of origin nor retrospective/prospective is mentioned in the provided 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)": "Not applicable. The study involves a chemical assay for LDL cholesterol measurement, not expert-based interpretation.",
  "4. Adjudication method (e.g. 2+1, 3+1, none) for the test set": "Not applicable. The study involves a chemical assay, and adjudication methods are typically used for qualitative or imaging-based assessments.",
  "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": "Not applicable. This is a study of a diagnostic reagent, not an AI-assisted interpretation by human readers.",
  "6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done": "Yes, this study represents a standalone performance evaluation of the SYNCHRON® Systems Direct LDL Cholesterol Reagent.",
  "7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)": "The ground truth for the method comparison was implicitly the results obtained from the Genzyme N-Geneous LDL Cholesterol Reagent on the Hitachi 911 clinical analyzer, which is itself a predicate device for quantitative determination of LDL cholesterol. For imprecision, the ground truth is the statistical variation around the measured mean values.",
  "8. The sample size for the training set": "Not applicable. This is a reagent assay, not a machine learning model, so there isn't a 'training set' in the conventional sense. The development of the reagent would involve its own pre-clinical testing and optimization.",
  "9. How the ground truth for the training set was established": "Not applicable. See point 8."
}

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