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The Accu-Chek Safe-T-Pro Plus lancing device is a sterile, single-use, disposable lancing device intended to be used by healthcare professionals. It is designed for capillary blood sampling from the fingertip of adults and children 1 year and older or, if the patient is a child under 1 year, from the heel.

The Accu-Chek Safe-T-Pro Plus lancing device is a sterile, single-use, disposable lancing device intended to be used by healthcare professionals. It is designed for capillary blood sampling from the fingertip of adults and children 1 year and older or, if the patient is a child under 1 year, from the heel.

The provided text is a 510(k) summary for a medical device called the "Accu-Chek Safe-T-Pro Plus Lancing Device." It describes the device, its intended use, and substantial equivalence to a predicate device.

However, the document does not contain any information about acceptance criteria for an AI-powered device, nor does it describe a study involving an AI algorithm.

The document specifically states under "Non-Clinical and/or Clinical Tests Summary & Conclusions":

"Clinical Testing is not applicable; risk analysis confirmed risks were addressed and mitigated appropriately. All residual risks after mitigation were acceptable, and communicated in the instructions for use as warnings. There were no special performance or safety concerns identified. See Risk documents provided in Biocompatability section."

Therefore, I cannot provide the requested information about an AI device's acceptance criteria and study proving it meets those criteria based on this document. The device in question is a physical lancing device, not an AI software.

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