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GlucoSure HT Plus Blood Glucose Monitoring System is intended to quantitatively measure blood glucose in fresh capillary whole blood drawn from fingertips, palm, or forearm. Alternative site testing for glucose test should be performed only during steady-state (when glucose is not changing rapidly). It is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control and should only be used by a single patient and it should not be shared. It is not intended for diagnosis or screening of diabetes or for neonatal use.
The GlucoSure HT Blood Glucose Test Strips are to be used with the GlucoSure HT Plus Blood Glucose Meter to quantitatively measure glucose in capillary whole blood taken from fingertips, palm, or forearm.

The GlucoSure HT Plus blood glucose monitoring system consists of the GlucoSure HT Plus meter and GlucoSure HT Test Strips. It is used for testing of blood glucose by self-testers at home.

The provided text describes the 510(k) premarket notification for the GlucoSure HT Plus Blood Glucose Monitoring System, which is a medical device for measuring blood glucose. The information necessary to fully answer your request regarding acceptance criteria and study proving device meets criteria (especially as it pertains to AI/algorithm performance) is not fully detailed in this document, as it focuses on the substantial equivalence to a predicate device for a glucose monitoring system, and not an AI-assisted diagnostic tool in the typical sense this question implies.

However, based on the provided text, I can infer and extract some relevant information as best as possible, particularly regarding the clinical testing and the overall performance evaluation for this type of device.

Key takeaway for AI-related questions: This document describes a blood glucose monitoring system, not an AI-based diagnostic device where radiologists or extensive adjudication methods for image analysis would typically apply. The "algorithm" mentioned refers to the measurement algorithm within the glucose meter, not necessarily a complex AI/ML algorithm for image interpretation.

Here's a breakdown based on the available text:

Acceptance Criteria and Device Performance (Inferred from device type and general FDA requirements for glucose meters):

For a blood glucose monitoring system, the primary acceptance criteria revolve around the accuracy of glucose measurements compared to a reference method. While specific numerical acceptance criteria (e.g., % within 15% range) are not explicitly stated in the provided summary, these are standard for blood glucose meters. The summary states:

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

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