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The CLEVER CHEK Auto-Code Voice Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the following alternative sites: the palm, the forearm, the upper-arm, the calf and the thigh. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

The alternative site testing in the CLEVER CHEK Auto-Code Voice Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions.

This system contains a speaking functionality which provides step by step instructions to aid visually impaired persons.

CLEVER CHEK Auto-Code Voice Blood Glucose Monitoring System

This looks like a 510(k) clearance letter for a blood glucose monitoring system, not a study report. Therefore, much of the requested information about acceptance criteria and study details for an AI/ML device is not directly available in these documents.

However, I can extract the general indication for use which implies the functional requirements of the device and how it is expected to perform, and then discuss what kind of studies would typically be done for such a device to meet acceptance criteria, even if the specifics aren't here.

Based on the provided document, the following information can be extracted or reasonably inferred:

The document describes the CLEVER CHEK Auto-Code Voice Blood Glucose Monitoring System, intended for quantitative measurement of glucose in fresh capillary whole blood.

1. A table of acceptance criteria and the reported device performance

The provided document does not explicitly list acceptance criteria or reported device performance in a table format. For blood glucose monitoring systems, performance is typically assessed against accuracy standards. A common standard is ISO 15197 for in vitro diagnostic test systems, which typically requires a certain percentage of results to fall within specific accuracy ranges when compared to a laboratory reference method.

• Inferred Performance Requirement (based on device type): The device is intended for "quantitative measurement of glucose." This implies accuracy and precision.
• Typical Acceptance Criteria (based on similar devices, not from this document):
  • For glucose concentrations

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