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The e-San Bluetooth Cradle is intended to be used by patients at home. It is physically connected to a LifeScan OneTouch® Ultra® Blood Glucose Monitoring System and wirelessly sends the signals (via Bluetooth V1.2) to a Bluetooth enabled cellular phone such as the Nokia 6230.

The e-San Bluetooth Cradle serves as the remote communication link between the LifeScan OneTouch® Ultra® Blood Glucose Monitoring System and a cellular telephone.

The t+ Diabetes System enables users to store and display data on the cellular phone, and to send data from the cellular telephone to a remote database for storage and display via the internet.

The e-San Bluetooth Cradle is connected to a LifeScan OneTouch® Ultra® Blood Glucose Monitoring System and uses short-range low power wireless transmission (Bluetooth V1.2) to send the data to a Bluetooth compatible cellular telephone such as the Nokia Model 6230. The t+ Diabetes System allows the blood glucose data to be stored and displayed on a cell phone, and transmitted to a centralized database for storage and display.

The provided document is a 510(k) summary for the Think Positive (t+) Diabetes Management System. It states that the device is substantially equivalent to a previous version and functions as an accessory to a blood glucose test system for data transmission and storage.

Based on the provided text, there is no information available about acceptance criteria or a study that proves the device meets specific performance criteria. The document focuses solely on establishing substantial equivalence to a predicate device, which is a regulatory pathway that often doesn't require new clinical performance studies if the fundamental technology and intended use are similar.

Therefore, for your request, I must state that none of the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or human reader performance is present in the provided document.

The document's conclusion is:

• "This pre-market submission has demonstrated Substantial Equivalence as defined and understood in Sections 513(f)(1) and 513(i)(l) of the Federal Food, Drug, and Cosmetic Act and guidance documents issued by the Center for Devices and Radiological Health."

This indicates that the submission did not include a study with performance metrics against acceptance criteria, but rather a comparison to a predicate device to show similar characteristics.

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