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The GS Infinity TM Meter device is used along with the G5 Infinity TM Test Strips for the quantitative measurement of glucose level in whole blood as an aid in monitoring the effectiveness of diabetes manage:nent in the home by patients with diabetes and in clinical settings by healthcare professionals. G5 Infinity TM System is for testing outside the body (in vitro diagnostic use only). Testing sites include the traditional fingertip testing along with alternate site testing on the dorsal palm, ventral palm, forearm, upper arm, calf and thigh. The G5 Infinity™ Blood Glucose Monitoring System is not intended for screening or diagnosis of diabetes and also not for use with neonates.

The Infinity ™ Monitor is an in vitro diagnostic device designed for measuring the concentration of glucose in whole blood, which is used with the Infinity ™ Test Strips.
The test principle is:
This device is an in vitro diagnostic product intended for the measurement of glucose concentration in human blood. The principle of the test relies upon a specific type of glucose in the blood sample, the dehydrogenase glucose that reacts to electrodes in the test strip. The test strip employs an electrochemical signal generating an electrical current that will stimulate a chemical reaction. This reaction is measured by the Meter and displayed as your blood glucose result.

The provided text describes the U.S. Diagnostics, Inc. G5 Infinity™ Blood Glucose Monitoring System, including its intended use and comparison to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets those criteria, nor does it include details about sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

The document is a 510(k) summary and clearance letter, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance study results that would include acceptance criteria and specific data about how those criteria were met.

Therefore, most of the requested information cannot be extracted from the provided text.

Here's what can be stated based on the given document:

• 1. A table of acceptance criteria and the reported device performance: This information is not available in the provided text. The document refers to "substantial equivalence" to predicate devices without listing specific performance metrics or their acceptance criteria.
• 2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): This information is not available in the provided text.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): This information is not available in the provided text.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: This information is not available in the provided text.
• 5. 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: This information is not available in the provided text. This device is a blood glucose monitoring system, not an AI-assisted diagnostic imaging device for human readers.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This information is not available in the provided text. The device is a "Blood Glucose Test System" for quantitative measurement of glucose, implying a direct output rather than an "algorithm only" performance in the context of interpretation by human readers.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): This information is not available in the provided text. For a blood glucose monitor, the "ground truth" would typically refer to a reference laboratory method for glucose measurement, but this is not mentioned.
• 8. The sample size for the training set: This information is not available in the provided text.
• 9. How the ground truth for the training set was established: This information is not available in the provided text.

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