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The DataPro™/DataPro Plus™ Clinical Chemistry Analyzer is a fully automated clinical chemistry analyzer intended for routine diagnostic clinical laboratory use. The DataPro™ has replaceable parts, automated maintenance monitoring and backup of both patient and system data. With a throughput of up to 230 tests per hour, the DataPro™ is intended for small and medium-sized laboratories, or as a backup analyzer in large volume laboratories.

The DataPro™/DataPro Plus™ Clinical Chemistry Analyzer is intended to be used in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae related to the measurement of various clinical assays, such as Albumin, Alkaline Phosphatase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Urea Nitrogen (BJ N), Calcium, Cholesterol, Creatinine, Direct Bilirubin, Glucose, Phosphorus, Total Billirubin, Total Protein, Triglyceride, and Uric Acid.

The DataPro™, and all of the reagents included in this test system are for in vitro diagnostic use only.

The DataPro™/DataPro Plus™ Clinical Chemistry Analyzer is a fully automated clinical chemistry analyzer intended for routine diagnostic clinical laboratory use. The DataPro™ has replaceable parts, automated maintenance monitoring and backup of both patient and system data. With a throughput of up to 230 tests per hour, the DataPro™ is intended for small and medium-sized laboratories, or as a backup analyzer in large volume laboratories.

The provided text is a 510(k) premarket notification approval letter for a clinical chemistry analyzer. It does not contain the detailed acceptance criteria or a study proving that the device meets those criteria, as typically found in a clinical study report or a detailed validation document.

This document primarily states that the FDA has reviewed the device and determined it to be substantially equivalent to legally marketed predicate devices. It lists the "Indications for Use" for the DataPro™/DataPro Plus™ Clinical Chemistry Analyzer, which describes its intended purpose and the types of assays it can perform.

Therefore, I cannot provide the requested information based on the given input regarding:

1. A table of acceptance criteria and the reported device performance
2. Sample sizes used for the test set and data provenance
3. Number of experts and qualifications
4. Adjudication method
5. MRMC comparative effectiveness study results
6. Standalone performance
7. Type of ground truth used
8. Sample size for the training set
9. Ground truth establishment for the training set

The document is purely an FDA approval letter, not a technical study report.

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1. The Thermo Electron Infinity™ ACE Reagent Kit is intended for the quantitative determination of ACE in human serum or plasma. The product is for in vitro diagnostic use only. Measurements obtained by this device are used in the diagnosis and treatment of diseases such as sarcoidosis, a disease characterized by the formation of nodules in the lungs, bones, and skin, and Gaucher`s disease, a hereditary disorder affecting the spleen.
2. The Thermo Electron Infinity™ ACE Calibrator is intended for the calibration of ACE assays. The product is for in vitro diagnostic use only.
3. The Thermo Electron ACE Normal and Elevated Controls are intended for monitoring the accuracy and precision of ACE assays. The product is for in vitro diagnostic use only.

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This document is a 510(k) premarket notification for in vitro diagnostic devices. It does not contain information about an AI/ML-based device or a study that uses acceptance criteria and device performance as typically understood for AI/ML or imaging devices. The devices described are reagent kits, calibrators, and controls for measuring Angiotensin Converting Enzyme (ACE) in human serum or plasma.

Therefore, I cannot extract the requested information from the provided text as it is not relevant to AI/ML or imaging device studies.

However, if this were an AI/ML or imaging device submission, the requested information would typically be found in sections detailing clinical study results, performance validation, or substantial equivalence comparisons, which are absent in this specific document.

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