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The Nova Primary Glucose Analyzer System is indicated for in vitro diagnostic use by healthcare professionals in clinical laboratory setting for the quantitative determination of Glucose in lithium heparinized venous whole blood and plasma.

The measurement of Glucose is used in the diagnosis and treatment of carbohydrate metabolism distuding diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and pancreatic islet cell carcinoma.

The Nova Primary Glucose Analyzer System is a small, portable laboratory glucose analyzer that measures blood glucose levels in lithium heparinized whole blood or plasma utilizing a glucose oxidase based sensor and membrane/cap assembly.

The Nova Primary Glucose Analyzer accepts samples from syringes, blood collection tubes, microcentrifuge tubes, and sample cups. The sample size for analysis is 25 microliters (aspirated volume).

Nova Primary System Components:
The Nova Primary Glucose Analyzer System is comprised of the following components.

• Nova Primary Glucose Analyzer
• Nova Primary Glucose Sensor
• Nova Primary Glucose Membrane
• Nova Primary Calibrator Cartridge
• Optional Barcode Scanner
• IFU/Labeling

Sample Types:
The Nova Primary Glucose Analyzer System accepts lithium heparinized venous whole blood and plasma.

The Nova Primary Glucose Analyzer System by Nova Biomedical Corporation is indicated for in vitro diagnostic use by healthcare professionals in clinical laboratory settings for the quantitative determination of Glucose in lithium heparinized venous whole blood and plasma.

The study presented does not explicitly list acceptance criteria in a tabular format with corresponding performance results. Instead, it describes performance testing conducted to demonstrate substantial equivalence to the predicate device, the YSI 2300 Stat Glucose and L-Lactate Analyzer. The performance tests included:

• Method Comparison Studies
• Precision/Reproducibility Studies
• Linearity Testing
• Specificity / Interference Testing
• Detection Limit
• Shelf Life Stability Testing

The "Summary of Performance Testing" section states, "The results of the performance testing confirmed that the Nova Primary Glucose Analyzer demonstrates substantial equivalence to the YSI 2300 Stat Glucose and L-Lactate Analyzer." This implies that the device met the criteria necessary to be considered substantially equivalent to the predicate device in terms of these performance characteristics. However, specific numerical acceptance criteria and the exact reported device performance metrics are not detailed in the provided text.

Here's an attempt to structure the information based on the provided text, while acknowledging the lack of explicit numerical acceptance criteria:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance

The document does not explicitly state the sample sizes used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature) for the performance testing. It only mentions that "Testing was completed to show that the Nova Primary Glucose Analyzer demonstrates substantial equivalence to the YSI 2300 Stat Glucose and L-Lactate Analyzer."

3. Number of Experts for Ground Truth and Qualifications

This information is not provided in the document. The device is a laboratory instrument for quantitative determination of glucose, and ground truth would typically be established by recognized reference methods or predicate devices, not by human experts in the diagnostic sense.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. As noted above, the ground truth is based on objective laboratory measurements and reference methods, not subjective assessments requiring adjudication.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically relevant for interpretative diagnostic devices where human reader performance is a key metric, often in image-based diagnostics. The Nova Primary Glucose Analyzer System is a quantitative measurement device.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)

Yes, the performance testing described (Method Comparison, Precision/Reproducibility, Linearity, Specificity/Interference, Detection Limit, Shelf Life Stability) would inherently be a standalone evaluation of the algorithm and device's accuracy and reliability in measuring glucose concentration. The device is designed for automated quantitative measurement.

7. Type of Ground Truth Used

The ground truth for the device's performance is established by comparison to a legally marketed predicate device (YSI 2300 Stat Glucose and L-Lactate Analyzer) and traceability to isotope dilution mass spectrometry (for plasma equivalent glucose results). This suggests established laboratory reference methods and comparison to a 'gold standard' device.

8. Sample Size for the Training Set

The document does not specify a separate "training set" sample size. For an analytical device like this, the "training" (calibration and algorithm development) is typically an internal process, and the performance testing is done on independent samples.

9. How Ground Truth for the Training Set Was Established

The document states that "All glucose measurement algorithms are intended to report plasma equivalent glucose results that are substantially equivalent to the predicate device plasma glucose result, and are traceable to isotope dilution mass spectrometry." This implies that the algorithms were developed or "trained" using data and methods that align with these established analytical principles and reference standards. However, the specific details of how this "ground truth" was established for internal algorithm development (training) are not elaborated.

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