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TRILOGY is a fully automated, discrete, software-driven, multi-purpose analyzer for spectrophotometric and potentiometric in vitro determination of analytes in body fluids. It is an open system intended for clinical use in a professional setting for use with various chemistry assays that may be adaptable to the analyzer depending on the reagent used to induce a photometric reaction.

TRILOGY is intended for the quantitative determination of glucose, creatinine and urea nitrogen in serum. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma. Creatinine measurements are used in the diagnosis and treatment of renal diseases, and in monitoring renal dialysis. Urea nitrogen measurements are used in the diagnosis and treatment of certain renal and metabolic diseases.

TRILOGY includes an optional Ion Selective Electrodes (ISE) module for the measurement of sodium, potassium, and chloride in serum and urine. These measurements are used to montor electrolyte balance and in the diagnosis and treatment of diseases involving electrolyte imbalance.

The TRILOGY Analyzer is a fully automated, multi-purpose analyzer used for analysis in clinical chemistry with optional ion selective electrode (ISE) module. The analyzer is intended for the in vitro measurement of various analytes in serum and urine.

The analyzer incorporates robotics, computer and communication technology to perform integrated tasks from pipetting and diluting of patient specimens, assaying specimens in Routine or STAT modes, performing spectrophotometric, and potentiometric modes simultaneously and analyzing data using multiple curve-fitting parameters.

The TRILOGY Analyzer is an open system for multiple disciplines including clinical chemistry and an optional ISE module.

Here's a breakdown of the acceptance criteria and study information for the TRILOGY Analyzer, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided text does not explicitly state specific quantitative acceptance criteria or detailed numerical performance achievements for each analyte (Glucose, Creatinine, Urea Nitrogen, Sodium, Potassium, Chloride). It rather states that the "results of all studies demonstrated that the TRILOGY Analyzer performed according to its specifications."

However, based on the performance testing mentioned, the categories of performance assessed would implicitly be the acceptance criteria:

2. Sample Size Used for the Test Set and Data Provenance:

The document

• Does not specify the exact sample size used for the test set in the performance studies.
• Does not specify the data provenance (e.g., country of origin, retrospective or prospective nature of the samples).

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

The document does not mention the use of experts to establish a ground truth. This is a common characteristic of in vitro diagnostic device (IVD) submissions for automated analyzers, where the "ground truth" is typically established by reference methods or validated predicate devices, rather than expert interpretation of results.

4. Adjudication Method for the Test Set:

Not applicable, as expert-based ground truth and adjudication are not described for this type of IVD device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not conducted. This type of study is primarily relevant for imaging devices or AI-assisted diagnostic tools where human reader performance is a key outcome. The TRILOGY Analyzer is an automated chemical analyzer, and its performance is evaluated against chemical reference methods and predicate devices, not human readers.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Yes, the performance testing described ("method comparison, precision, linearity, interference, and limit of quantitation") represents a standalone study of the device's performance. The TRILOGY Analyzer operates as an automated system without direct human intervention in the analytical process once initiated. The results are generated solely by the analyzer.

7. The Type of Ground Truth Used:

The ground truth for the performance studies was implicitly established by:

• Reference analytical methods: For assessing accuracy and linearity.
• Validated predicate devices: For method comparison studies, where the predicate device's results serve as the comparison standard.
• Known concentrations/samples: For evaluating precision, linearity curves, and limits of quantitation.

8. The Sample Size for the Training Set:

The document does not specify a separate training set or its sample size. For automated chemistry analyzers like the TRILOGY, the "training" (calibration and optimization) is typically part of the development and manufacturing process, where internal quality controls and calibrators are used, rather than a distinct "training set" in the context of machine learning. The provided text describes validation/verification studies demonstrating the device's performance post-development.

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

As above, the concept of a "training set" with ground truth in the machine learning sense is not explicitly applicable or described for this traditional automated chemistry analyzer. The ground truth for internal calibration and verification would be established using:

• Certified reference materials.
• Calibrators with known concentrations traceable to international standards.
• Internal quality control samples with established target values.

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