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The Comprehensive Metabolic Panel is intended to be used for the quantitative determination of Alkaline Phosphate (ALP), Alanine Aminotransferase (ALP/GPT), Aspartate Aminotransferase (AST/GOT), Blood Urea Nitrogen (BUN) and Creatinine (CREA) in concentrations in lithium-heparinized venous whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location.

• Alkaline phosphatase or its isoenzymes measurements are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.

• Alanine aminotransferase measurements are used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases.

• Aspartate aminotransferase measurements are used in the diagnosis and treatment of certain types of liver and heart disease.

• Blood urea nitrogen measurements are used in the diagnosis and treatment of certain types of renal and metabolic diseases.

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

The skyla Clinical Chemistry Analyzer is an in-vitro diagnostic device for the quantitative determination of clinical chemistry analytes in lithium-heparinized venous whole blood, heparinized plasma, or serum. It is for clinical laboratory and point-of-care use.

The Minicare C300 Clinical Analyzer is an in-vitro diagnostic devices for the quantitative determination of clinical chemistry analytes in lithium-heparinized venous whole blood, heparinized plasma, or serum. It is for clinical laboratory and point-of-care use.

The skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry Analyzer (private label) and Comprehensive Metabolic Panel is an automatic chemistry system intended for use in clinical laboratories or point-of-care locations. The system consists of a portable analyzer and single-use disposable reagent panel discs.

The analyzer utilizes precision photometric measurement technology, combined with the use of specific reagent panel disc, to measure the amount of substance in blood. The analyzer measures absorbance change of each reaction well in reagent panel disc and covert it to a concentration value for each analyte included on the panel.

The skyla and Minicare Comprehensive Metabolic Panel reagent disc (which contains the Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Blood Urea Nitrogen and Creatinine test systems) is designed to separate a heparinized venous whole blood sample into plasma and blood cells. The disc meters the required quantity of plasma and diluent, mixes the plasma with diluent, and delivers the mixture to the reaction cuvettes along the disc perimeter. The diluted plasma mixes with the reagent beads, initiating the chemical reactions that are then monitored by the analyzer.

The Lite-On Technology Corp.'s Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, and Minicare C300 Clinical Chemistry Analyzer (K171971) were evaluated for substantial equivalence. The acceptance criteria and performance data are primarily based on precision, matrix comparison, detection limits, linearity, and interference testing.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied by the predicate device's performance and the established clinical laboratory standards (e.g., CLSI guidelines, recovery within 90-110% for interference). The reported device performance aligns with these expectations.

2. Sample Sizes Used for the Test Set and Data Provenance

• Internal Precision/Reproducibility: 80 runs per level (quadruplicate testing a day for 20 working days) for each of the three serum levels for all 5 analytes. Data provenance is not specified (e.g., country of origin) but refers to "patient serum samples." Implied prospective collection for the study.
• Matrix Comparison: 40 human samples. Data provenance not specified. Implied prospective collection for the study.
• Detection Limit: LoB: 60 measurements of a near-zero sample over 10 days. LoD/LoQ: serum samples containing very low concentrations, tested in triplicate using 2 lots of reagent discs for 10 days. Data provenance not specified. Implied prospective collection.
• Linearity: 9 intermediate dilutions created from high and low human serum pool samples, plus spiked samples. Data provenance not specified. Implied prospective collection.
• Endogenous Interferences: Not explicitly stated, but implies multiple samples to test two different concentrations (normal and abnormal) of analytes against specified interference levels. Data provenance not specified. Implied prospective collection.
• Exogenous Substances: Two concentrations (low and high level) of samples for each of the 10 potential interferents. Data provenance not specified. Implied prospective collection.
• Point-of-Care (POC) Method Comparison: Over 120 heparinized venous whole blood and serum samples for each analyte. Data provenance not specified; likely collected from the three POC sites, implying prospective collection.
• Point-of-Care (POC) Precision Studies: Three levels of human serum samples from POC sites, assayed in quadruplicate twice a day for 20 days. Data provenance not specified. Implied prospective collection.
• Point-of-Care (POC) Whole Blood Precision: Not explicitly stated, but tabular data suggests multiple analyses (mean, SD, CV) for low, medium, and high samples across 3 POC sites and multiple operators (OP1, OP2, OP3).

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

This type of submission (510k for a clinical chemistry analyzer) does not typically involve human experts establishing a "ground truth" for the test set in the same way an image analysis or diagnostic AI device would. Instead, the ground truth is established by:

• Reference Methods/Materials: Traceability to established reference methods (e.g., IFCC reference method for ALT/ALP/AST, CDC reference method for BUN, IDMS Reference Method for CREA) and reference materials (NIST SRM967).
• Comparative Clinical Analyzers: For method comparison studies, the Beckman Coulter AU2700 clinical analyzer served as the comparative (reference) method.

Therefore, the "experts" in this context are the established, validated, and traceable laboratory methods and instruments, rather than individual human practitioners.

4. Adjudication Method for the Test Set

Not applicable. Diagnostic test performance for clinical chemistry analyzers is typically evaluated by statistical comparison to a reference method or established clinical ranges, not by an adjudication process as seen in clinical trial settings for diagnostic imaging.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where multiple human readers interpret cases with and without AI assistance. This submission is for a clinical chemistry analyzer.

However, the "POC Precision studies" did evaluate performance across multiple operators (9 operators) at three POC sites. This demonstrates inter-operator variability, which is a related concept to multi-reader studies in a laboratory context, but it does not measure an "improvement with AI vs. without AI assistance" since the device itself is the primary measurement tool, not an AI assistant to a human reader.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Yes, the studies presented are generally "standalone" performance evaluations of the device (skyla/Minicare Clinical Chemistry Analyzer with Comprehensive Metabolic Panel) itself. The device automatically measures analytes and displays results; there isn't an "algorithm only" component separate from the integrated device performance. All performance data (precision, linearity, detection limits, interference) are solely based on the device's output.

7. The Type of Ground Truth Used

The ground truth for the device's performance is established through:

• Traceability to Reference Methods/Materials: For calibration and analytical accuracy (e.g., IFCC, CDC, IDMS reference methods, NIST reference materials).
• Comparative Clinical Analyzers: The Beckman Coulter AU2700 served as the comparative method for method comparison studies, essentially acting as the "ground truth" or reference for evaluating the test device's performance on patient samples.
• Known Concentrations: For studies like linearity, detection limits, and interference, samples with known or spiked concentrations are used.

8. The Sample Size for the Training Set

This document does not specify a separate "training set" in the context of machine learning or AI. This device is a traditional in-vitro diagnostic (IVD) clinical chemistry analyzer. Its development would involve internal validation and optimization processes by the manufacturer, which might loosely be considered "training," but it's not described as an AI model training set with a specific size or provenance.

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

As this is a traditional IVD device, the concept of a "training set" for an AI model's ground truth is not applicable in the way it would be for AI-powered diagnostic software. The "ground truth" for the development and internal validation of such a device is established through:

• Chemical Principles and Reactions: The underlying scientific principles of colorimetry and specific reagent reactions form the fundamental 'ground truth' for measurement.
• Calibration Standards: The device is calibrated using standards whose concentrations are traceable to recognized reference methods and materials, ensuring accurate quantitative measurements.
• Quality Control Materials: Known quality control materials are used to ensure the device performs within expected ranges over time.

These elements collectively serve as the basis for ensuring the device's accuracy and reliability during its design, development, and manufacturing phases.

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