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The BioScanner Glucose Test Strips are intended to be used by healthcare professionals to measure glucose in whole blood and by individuals with diabetes to measure fingerstick whole blood at home. Glucose measurements are used in the management of carbohydrate metabolism disorders.

Glucose in the whole blood sample reacts with glucose oxidase in the presence of peroxidase, 4-aminoantipyrine and a di-substituted aniline to produce a colored end product. The BioScanner reads the percent reflectance of the color produced and converts reflectance into glucose concentration.

The provided text is a 510(k) summary for the BioScanner Glucose Test Strips, which is a medical device for measuring glucose levels. While it describes the device, its intended use, and substantial equivalence to a predicate device, it does not contain detailed information regarding the acceptance criteria, study design, or performance metrics in the way you've requested for a device evaluation.

Specifically, the document lacks the following information:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set and data provenance.
• Number of experts used to establish ground truth and their qualifications.
• Adjudication method for the test set.
• Results of a multi-reader multi-case (MRMC) comparative effectiveness study.
• Detailed standalone (algorithm only) performance results.
• The specific type of ground truth used (e.g., pathology, outcomes data) beyond "laboratory plasma glucose result" as a reference for calibration.
• Sample size for the training set.
• How ground truth for the training set was established.

The document states:

• "Both systems are calibrated with a glucose hexokinase laboratory method as the . reference." This implies that a laboratory reference method (glucose hexokinase) is used for calibration, which serves as a form of ground truth for that process. However, it doesn't describe the performance study or acceptance criteria for the final device.
• "Both systems provide a result that correlates to the laboratory plasma glucose result." This is a general statement about correlation but doesn't specify the correlation strength (e.g., R-squared, bias, precision) or the acceptance criteria for that correlation.

To answer your request comprehensively, one would typically need a separate clinical performance study report or verification and validation documentation, which is not included in this 510(k) summary. This summary primarily focuses on regulatory approval based on substantial equivalence to a predicate device, rather than detailed performance data and acceptance criteria from a specific clinical study.

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