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ELITech Clinical Systems CREATININE PAP SL is intended for the quantitative in vitro diagnostic determination of creatinine in human serum, plasma and urine on ELITech Clinical Systems Selectra Pro Series Analyzers. It is not intended for use in Point of Care settings.

Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.

ELITech Clinical Systems ELICAL 2 is a multi-parametric calibrator for in vitro diagnostic use in the calibration of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Selectra Pro Series Analyzers.

ELITech Clinical Systems ELITROL I and ELITROL II are multi-parametric control sera for in vitro diagnostic use in quality control of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Selectra Pro Series Analyzers.

ELITech Clinical Systems URINE CONTROL BI-LEVEL is a set of 2 levels of urine controls used for in vitro diagnostic in the quality control of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Selectra Pro Series Analyzers.

ELITech Clinical Systems CREATININE PAP SL is available as kit only. It consists of a bi-reagent R1 and R2 whose composition is, for R1: MOPS buffer (pH 7.50), EHSPT, Creatinase, Sarcosine oxidase, Ascorbate oxidase. For R2: MOPS buffer (pH 7.50), 4-Aminoantipyrine, Creatininase, Peroxidase, sodium azide.

ELITech Clinical Systems ELICAL2 is a lyophilized calibrator based on human serum containing constituents to ensure optimal calibration. ELICAL 2 is prepared exclusively from the blood of donors tested individually and found to be negative for HbsAg and to the antibodies to HCV and HIV according to FDA-approved methods.

ELITech Clinical Systems ELITROL I and ELITROL II are two level quality control products consisting of a lyophilized human serum containing constituents at desired levels. ELITROL I and ELITROL II are prepared exclusively from the blood of donors tested individually and found to be negative for HbsAg and to antibodies to HCV and HIV according to FDA-approved methods.

ELITech Clinical Systems URINE CONTROL BI-LEVEL is a liquid solution prepared from human urine supplemented with constituents of human and animal origin, chemicals, preservatives and stabilizers. Human sera corresponding to the URINE CONTROL BI-LEVEL were tested for each urine donor and found to be negative for HbsAg and antibodies to HCV and HIV-1/HIV-2 according to FDA-approved methods.

1. Acceptance Criteria and Reported Device Performance:

2. Sample Sizes and Data Provenance:

• Test Set Sample Sizes:
  • Precision (Serum/Plasma and Urine): 80 measurements per level (3 levels for each matrix).
  • Method Comparison (Serum/Plasma): 100 patient serum samples.
  • Method Comparison (Urine): 54 patient urine samples.
  • Matrix Comparison (Plasma): 43 patient plasma samples (lithium heparin).
  • Detection Limit (Serum/Plasma and Urine): 15 measurements of 4 samples for LoD and LoQ for each matrix.
• Data Provenance: The document does not explicitly state the country of origin for the patient samples or if the data was retrospective or prospective. However, the studies were conducted by ELITech Clinical Systems SAS, which is located in France, suggesting the data may originate from a European setting. The methodology described (e.g., patient sample testing, specific protocols) implies these were prospective studies where samples were collected and tested as part of the validation process.

3. Number of Experts and Qualifications for Ground Truth:

The document describes performance studies for an in-vitro diagnostic (IVD) reagent for creatinine measurement. For such devices, "ground truth" is typically established by reference methods or validated comparative methods.

• No human experts were used to establish ground truth for the test values of the samples in the analytical performance studies (precision, linearity, detection limit, interference). These are determined by the measurements themselves and compared against established analytical criteria and industry standards.
• For Traceability, ELITech Clinical Systems ELICAL 2 calibrator values are traceable to the ID-MS (Isotope Dilution -Mass Spectrometry) reference method. This is considered the "gold standard" for accuracy in many clinical chemistry analytes and represents the highest level of ground truth for calibration.
• For Method Comparison, the "ground truth" for the comparative study was the results obtained from the predicate device, the Roche Diagnostics CREP2 (Creatinine Plus ver 2) reagent on a cobas c111 analyzer. The predicate device itself has undergone its own validation and regulatory clearance processes.

4. Adjudication Method:

• None. Adjudication methods (like 2+1, 3+1) are typically used in image-based diagnostic studies where human interpretation of medical images generates the ground truth, and discrepancies between readers need to be resolved. This document describes an IVD device for quantitative chemical analysis, where measurements are objective and do not involve human interpretation requiring adjudication.

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

• No. An MRMC comparative effectiveness study was not done. These studies are relevant for AI-powered diagnostic tools that assist human readers (e.g., radiologists interpreting images). This device is an in-vitro diagnostic reagent and does not involve human readers in the diagnostic process beyond performing the test and interpreting the quantitative result.

6. Standalone (Algorithm Only) Performance:

• Yes, effectively. The performance described (precision, linearity, detection limits, interference, method comparison) represents the standalone performance of the ELITech Clinical Systems CREATININE PAP SL reagent as performed on the ELITech Clinical Systems Selectra Pro Series Analyzers, without human interpretation as part of the measurement process itself. The "algorithm" here is the enzymatic colorimetric assay methodology of the reagent combined with the automated analyzer.

7. Type of Ground Truth Used:

• Primarily Expert Concensus (ID-MS Traceability) and Comparative Method (Predicate Device):
  • For calibration and absolute accuracy, the calibrator (ELICAL 2) is traceable to the ID-MS (Isotope Dilution -Mass Spectrometry) reference method, which is a highly accurate, consensus-driven method used by reference laboratories to establish true values.
  • For method comparison, the ground truth was established by the predicate device (Roche Diagnostics CREP2 on a cobas c111 analyzer). The performance of the new device was compared against this already legally marketed and validated method.
  • For analytical performance characteristics like precision, linearity, detection limits, and interference, the "ground truth" is defined by adherence to established analytical protocols (CLSI guidelines) and the reproducibility/accuracy of the measurements themselves in controlled conditions.

8. Sample Size for the Training Set:

• Not explicitly stated/Not applicable in the traditional sense. This is an in-vitro diagnostic reagent, not an AI/machine learning model that typically involves a "training set" in the computational sense.
• However, the development of such reagents involves extensive research and development, including formulation, optimization, and preliminary testing, which could be considered an analogous "training" phase to refine the product. The document highlights the use of CLSI standard protocols for performance evaluation, which are used to test the final product, not to "train" it.

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

• Not applicable in the traditional AI/ML sense. For an IVD reagent, the "ground truth" during its development (analogous to training) would involve:
  • Chemical principle validation: Ensuring the enzymatic reaction effectively measures creatinine.
  • Formulation optimization: Through numerous experiments, determining optimal concentrations of reagents for sensitivity, specificity, and stability.
  • Calibration standards: Developing and validating calibrators against recognized reference materials (like ID-MS) to ensure accurate quantification across the measuring range.
  • This iterative process relies on established chemical principles, analytical instrumentation, and validation against known standards and samples with established values, often aligned with international reference methods.

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ELITech Clinical Systems ELICAL 2 is a multi-parametric calibrator for in vitro diagnostic use in the calibration of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Selectra Analyzers.

ELITech Clinical Systems ELITROL I and ELITROL II are multi-parametric control sera for in vitro diagnostic use in quality control of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Selectra Analyzers.

ELITech Clinical Systems ELICAL 2 is a lyophilized calibrator based on human serum containing constituents to ensure optimal calibration. ELICAL 2 is prepared exclusively from the blood of donors tested individually and found to be negative for HbsAg and to antibodies to HCV and HIV according to FDA-approved methods or methods in compliance with the European Directive 98/79/EC, Annex II, List A.

ELITech Clinical Systems ELITROL I and ELITROL II are two level quality control products consisting of lyophilized human serum containing constituents at desired levels. Elitrol I and Elitrol II are prepared exclusively from the blood of donors tested individually and found to be negative for HbsAg and to antibodies to HCV and HIV according to FDA-approved methods or methods in compliance with the European Directive 98/79/EC, Annex II, List A.

The provided text describes two in vitro diagnostic devices, ELICAL 2 (a calibrator) and ELITROL I / ELITROL II (controls), and their comparison to predicate devices for 510(k) clearance.

However, the documentation provided does not contain information related to an AI/ML-based device. It describes traditional in vitro diagnostic devices, specifically a multi-analyte calibrator and multi-analyte controls based on human serum.

Therefore, I cannot provide an answer that includes details typical of an AI/ML device study, such as sample sizes for test/training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone algorithm performance, or a table of acceptance criteria and reported device performance for an AI/ML model.

The document focuses on demonstrating substantial equivalence of the new calibrator and control devices to existing predicate devices based on attributes like intended use, format, levels, handling, traceability, and stability. The "performance data" mentioned in the Conclusion likely refers to the analytical performance characteristics (e.g., stability) that were tested to show the new devices perform comparably to the predicates, rather than the performance of an AI algorithm.

To answer your request thoroughly, I need information about an AI/ML device study. The current document does not provide the necessary details.

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