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This reagent is intended for the quantitative enzymatic determination of glucose in serum or plasma. For in vitro diagnostic use only. This glucose test system is a device intended to measure glucose quantitatively in serum or plasma. 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 tumors.

Glucose test system

This is a 510(k) premarket notification for a Glucose Test System. The provided document does not contain a detailed study report with acceptance criteria and device performance as typically expected for a full medical device evaluation. Instead, it is a letter from the FDA confirming substantial equivalence to a predicate device, based on information provided in the original 510(k) submission (K041052), which is not fully included here.

However, based on the Indications for Use (Page 2), we can infer the primary function of the device and thus, conceptualize what typical acceptance criteria and study designs would entail for such a device.

Here's an interpretation and hypothetical construction of the requested information, given the limitations of the provided document.

Understanding the Device: The device is a "Glucose Test System" intended for the "quantitative enzymatic determination of glucose in serum or plasma." It's for "in vitro diagnostic use only" and its measurements are used in the "diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, gestational diabetes, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell tumors." The intended patient population is "adult, pediatric, and neonatal."

1. Table of Acceptance Criteria and Reported Device Performance

Since specific acceptance criteria and detailed performance data are not explicitly stated in this FDA letter, the following table represents typical performance characteristics and acceptance criteria for a glucose test system, along with hypothetical "reported device performance" values that would generally be expected for a device receiving FDA clearance. These are inferred based on standard practices for such devices.

Note: The FDA letter indicates this is a "Glucose Test System" for serum or plasma, suggesting it's likely a lab-based or professional-use system, which typically has stricter accuracy and precision requirements than home-use blood glucose meters. The "enzymatic determination" further points to a robust analytical method.

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

• Sample Size: The document does not specify the sample size for any test set. For a glucose test system evaluating accuracy, typical studies involve hundreds to thousands of patient samples (e.g., 100-200 samples per comparison, if comparing to a reference method across the clinical range, with additional samples for interference, precision, and other studies). For FDA submission, it would likely involve a sufficient number of samples to cover the entire clinically reportable range from low to high glucose concentrations, usually with adequate representation across different patient populations (e.g., diabetic, non-diabetic, pediatric, neonatal, as indicated).
• Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. Typically, clinical studies for FDA submissions are prospective and conducted in the United States, though multi-center international studies are also common.

3. Number of Experts Used to Establish Ground Truth and Qualifications

For a glucose test system, "ground truth" is typically established by a highly accurate and precise reference method, not by human expert interpretation in the same way as imaging studies.

• Ground Truth Establishment: Ground truth for glucose measurements is typically established using a primary measurement procedure such as isotope dilution-mass spectrometry (ID-MS) or a well-validated secondary reference method like a hexokinase reference method performed on a highly calibrated and quality-controlled laboratory analyzer.
• "Experts": The "experts" in this context would be highly trained clinical chemists or laboratory personnel with extensive experience in operating and maintaining these reference methods, ensuring their accuracy, calibration, and quality control. There isn't a "number of experts" in the sense of inter-rater agreement for diagnosis; rather, it's about the rigor of the reference laboratory and method.

4. Adjudication Method for the Test Set

This concept is not applicable to the type of device described. Adjudication methods (like 2+1, 3+1) are used for resolving discrepancies in human expert interpretations, particularly in qualitative or semi-quantitative assessments (e.g., reading medical images, clinical event classification). For a quantitative diagnostic device like a glucose meter, "ground truth" is an objective numerical value obtained from a reference method, not a subjective interpretation requiring adjudication.

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

• Not applicable. MRMC studies are typically performed for devices that involve human interpretation, such as diagnostic imaging AI tools, to assess how an AI system might improve human reader performance. A glucose test system provides a quantitative numerical output that doesn't inherently involve human "reading" or "interpretation" in the same way. The device's output is directly used by healthcare professionals.

6. Standalone (Algorithm Only) Performance Study

• Yes, a standalone study is fundamental. For a glucose test system, the primary performance evaluation is a standalone study of the algorithm/device itself. This involves:
  • Comparing the device's quantitative glucose measurements against those obtained from a recognized reference method.
  • Evaluating precision (repeatability and reproducibility).
  • Testing for linearity, limits of detection/quantitation, and interferences.
  • These studies assess the device's inherent analytical performance without human intervention in the result generation process.

7. Type of Ground Truth Used

• As described in Section 3, the ground truth is established by a highly accurate and precise reference method, typically a hexokinase reference method or isotope dilution-mass spectrometry (ID-MS), recognized as the gold standard for glucose measurement. This is essentially an objective laboratory measurement from a certified reference laboratory.

8. Sample Size for the Training Set

The document does not provide information on a training set size.

• For enzymatic glucose test systems, specifically for the reagent itself, there isn't a "training set" in the machine learning sense. The device's underlying chemical and enzymatic reactions are based on known spectrophotometric or electrochemical principles. Manufacturers would perform extensive development and validation using a large number of samples, analytical studies, and calibration sets to optimize the reagent formulation, instrument parameters, and ensure robust performance across various conditions. This development might involve hundreds to thousands of samples, but it's not typically categorized as a "training set" for an algorithm in the way AI/ML devices do. If there were any sophisticated signal processing or calibration algorithms, those would be developed on proprietary datasets.

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

• As mentioned above, for a traditional enzymatic glucose test system, the concept of a "training set" with ground truth (as in AI/ML) is not directly applicable.
• Instead, during the development phase, manufacturers would use well-characterized glucose solutions of known concentrations (often traceable to NIST standards) and patient samples whose glucose levels have been verified by a reference method to:
  • Calibrate the device.
  • Optimize reagent formulations and reaction conditions.
  • Verify basic analytical performance (e.g., linearity, sensitivity).
  • This "ground truth" for development and calibration would similarly be derived from highly accurate reference methods or certified reference materials.

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