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The Bayer ADVIA IMS® Glucose assay is an in vitro diagnostic device for use to measure glucose in human serum, plasma, urine and cerebrospinal fluid (CSF) on the ADVIA IMS® System. Such measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus and neonatal hypoglycemia.

The ADVIA IMS® Glucose method is based on the combination of hexokinase (HK) and glucose-6-phosphate dehydrogenase (G6PD) for the specific measurement of glucose in serum, plasma, urine and cerebral spinal fluid.

Here's an analysis of the provided 510(k) summary, structured to answer your questions regarding acceptance criteria and the study proving device performance:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the comparison to the predicate device and the presented performance characteristics. The study demonstrates comparable performance in terms of imprecision and correlation to the predicate device.

• Level ~59 mg/dL: 1.8% (Predicate) | - Level 36 mg/dL: 2.1%
• Level 60 mg/dL: 2.1% |
  | CSF Imprecision (Total CV %) | - Level ~31 mg/dL: 2.7% (Predicate)
• Level ~59 mg/dL: 3.1% (Predicate) | - Level 36 mg/dL: 2.3%
• Level 60 mg/dL: 2.2% |
  | CSF Correlation (Regression Equation Slope) | Expected to be close to 1.0 (indicating good agreement with predicate) | 0.92 |
  | CSF Correlation (Regression Equation Y-intercept) | Expected to be close to 0 (indicating good agreement with predicate) | 2.3 |
  | CSF Correlation (Syx - Residual Standard Deviation) | Not explicitly stated but lower values indicate better fit | 1.9 |
  | CSF Correlation (r - Correlation Coefficient) | Expected to be close to 1.0 (indicating strong correlation) | 0.997 |
  | Analytical Range | Not explicitly stated for predicate in summary, but the predicate likely has a similar range for glucose measurement. | 1 mg/dL - 600 mg/dL |
  | Minimum Detectable Concentration | Not explicitly stated for predicate in summary. | 1 mg/dL |

2. Sample Size and Data Provenance

• Test Set Sample Size: 64 CSF samples were used for the CSF correlation study. The sample sizes for the imprecision studies are not explicitly stated as a single number but are implied by the "Within-run CV" and "Total CV" which typically involve multiple runs and replicates.
• Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective).

3. Number of Experts and Their Qualifications for Ground Truth

This information is not applicable and therefore not provided. The study compares the performance of a new in vitro diagnostic device to a legally marketed predicate device, not against human expert interpretation of images or other subjective assessments. The "ground truth" here is the measurement obtained from the predicate device.

4. Adjudication Method for the Test Set

Not applicable. This is a comparison between two quantitative diagnostic devices, not a study involving human interpretation requiring adjudication.

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

No. This study is for an in vitro diagnostic device (glucose assay), not an AI algorithm assisting human readers in diagnostic interpretation. Therefore, an MRMC study is not relevant.

6. Standalone (Algorithm Only) Performance Study

Yes, in a sense. The entire submission describes the standalone performance of the ADVIA IMS Glucose assay in comparison to the predicate device. There is no human-in-the-loop component for the measurement of glucose in this context.

7. Type of Ground Truth Used

The "ground truth" for the performance evaluation is the quantitative measurement obtained from the predicate device, the Bayer ADVIA 1650 Glucose Hexokinase II. The study aims to demonstrate substantial equivalence by showing that the new device's measurements correlate strongly with those of the predicate.

8. Sample Size for the Training Set

Not applicable. This is an in vitro diagnostic device based on established biochemical principles (hexokinase and G6PD), not an AI algorithm that requires a "training set" in the machine learning sense. The device is developed and validated through analytical studies, not trained on data.

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

Not applicable, as there is no "training set" for this type of IVD device. The method relies on well-understood chemical reactions.

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