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The Express Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood. Testing is done outside the body (in vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes, or in a clinical setting by health care professionals, as an aid to monitor the effectiveness of diabetes control.

Express Control Solution is intended for use with the Express as a quality control check to verify the accuracy of blood glucose test results. Use the Express Control Solution to verify that the Express System is functioning properly.

Device Description

The Express Blood Glucose Monitoring System includes a disposable meter containing 100 biosensors (test strips) plus control solution. It is intended for over-the-counter, home use by diabetics to monitor their blood glucose levels, or for use in a clinical setting by healthcare professionals. The system tests fresh capillary whole blood. The meter is a portable, battery-operated instrument.

AI/ML Overview

Here's an analysis of the provided text regarding the Express Blood Glucose Monitoring System, formatted to address your specific points:

Since this is a blood glucose monitoring system, the "acceptance criteria" are typically related to the accuracy and precision of glucose measurements, often compared against a reference method (like a YSI analyzer) or a predicate device. The "device performance" refers to the results obtained from the non-clinical and clinical testing sections.

Acceptance Criteria and Reported Device Performance

Criteria Type	Acceptance Criteria (Implied)	Reported Device Performance and Evidence
Precision	Within-run and between-run precision values should be substantially equivalent to the predicate device and meet FDA Guidance Document recommendations.	Within-run Precision: Twenty replicates at six glucose concentrations across the performance range for six spiked venous whole blood samples. Performed within four hours of blood collection. Between-run Precision: Twenty replicates per day at six glucose concentrations using six tests with six different blood donors. Result: "The within-run and between-run precision values were substantially equivalent to that of the predicate."
Hematocrit Effect	Acceptable accuracy within the tested hematocrit range.	Study Design: Evaluated at a range of hematocrit levels from 30% to 55%. YSI plasma-referenced data used for comparison. Result: "Results showed acceptable accuracy within this hematocrit range."
Altitude Effect	No significant effect on performance due to high elevation.	Study Design: Tested using two control solutions and capillary whole blood spiked to three different levels. Performed at 800-feet and 40,000-feet elevations. Result: "Evaluation of mean values and CVs indicated no significant effect of high elevation on performance. The Express Blood Glucose Monitoring System is qualified at altitudes up to 10,000 ft. above sea level." (It's important to note the device is qualified to 10,000 ft, even though testing went up to 40,000 ft, suggesting that the 40,000 ft test might have demonstrated the lack of effect up to the qualified altitude).
Dynamic Range / Linearity	Good performance across the specified dynamic range (20-600 mg/dL).	Study Design: Testing conducted using venous blood spiked with D-glucose to provide samples across the 20-600 mg/dL dynamic range. Used Express Strip Readers and one YSI glucose analyzer. Result: "The results demonstrated good performance across the 20-600 mg/dL range."
Accuracy / Method Correlation	Good correlation with the YSI plasma reference method, and substantially equivalent regression statistics to the predicate device.	Study Design: Compared Express Strip Reader against the predicate and the YSI 2300 analyzer (reference method). Included men and women, Type 1 and Type 2 diabetes, ages 18-80s, and a wide range of educational levels. Blood glucose values encompassed 30-90 mg/dL (low end) to over 250 mg/dL (high end). Result: "Linear regressions statistics showed good correlation between Express Strip Reader results and the YSI plasma reference method, whether testing was carried out by the clinician or the patient. Regression statistics were substantially equivalent to those obtained for the predicate device."

Additional Information Addressing Your Request:

Sample size used for the test set and the data provenance:
- Precision Study:
  - Within-run: Twenty replicates.
  - Between-run: Twenty replicates per day.
  - Blood Donors: Six different blood donors (for between-run).
- Hematocrit Study: Not specified how many samples or donors were used for the hematocrit range evaluation, only the range of hematocrit (30-55%).
- Altitude Study: Not specified, only mentions "two control solutions and capillary whole blood spiked to three different levels."
- Dynamic Range/Linearity: Not specified how many samples/replicates were used, only that venous blood was spiked to cover the range.
- Accuracy/Method Correlation: Not explicitly stated, but implies a diverse group of "both men and women, both Type 1 and Type 2 diabetes, ages from eighteen to eighties, and a wide range of educational levels" was included.
- Data Provenance: Not explicitly stated, but typically clinical studies for 510(k) submissions in the US are conducted in the US. The reference to "YSI plasma-referenced data" suggests a well-established laboratory method for comparison. The studies appear to be prospective as they describe specific testing protocols.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this is an in-vitro diagnostic device measuring a quantitative analyte (glucose). The "ground truth" is established by a highly accurate reference instrument (YSI 2300 analyzer) or by comparing against the predicate device. No human expert consensus for image interpretation is involved.
Adjudication method for the test set:
- Not applicable. The "ground truth" (reference method) for glucose measurement doesn't involve subjective human adjudication. It's an objective measurement compared against another objective measurement.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is not an imaging AI device requiring human reader interpretation or assistance. The study evaluates the device's accuracy in measuring glucose, which is a standalone quantitative measurement. The "patient use" aspect of the accuracy study implies that both clinicians and patients used the device, suggesting a form of usability/performance evaluation for different user groups, but not an MRMC study in the typical AI sense.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, this entire study is effectively a standalone performance evaluation of the device (Express Strip Reader) itself. While patients and clinicians used the device, their role was as the users performing the test, not as "human-in-the-loop" for an algorithm's decision-making process. The system provides a direct blood glucose measurement.
The type of ground truth used:
- Reference Method: YSI 2300 analyzer (for accuracy/method correlation, hematocrit, and dynamic range).
- Predicate Device: Hypoguard Advance™ Blood Glucose Monitoring System (for substantial equivalence claims in precision and accuracy).
- Spiked Samples: Used in precision, altitude, and dynamic range studies where known concentrations of glucose were introduced into blood samples or control solutions.
The sample size for the training set:
- This is a traditional medical device (blood glucose meter), not an AI/machine learning product. Therefore, there is no "training set" in the context of machine learning model development. The device relies on a pre-programmed electrochemical or optical methodology, not a learned algorithm.
How the ground truth for the training set was established:
- Not applicable for the same reason as point 7.

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