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The Facet Aurora Reusable Lancet Base (commonly referred to as a lancing device) is a non-sterile reusable device which provides a spring-loaded mechanism to quickly eject and retract a lancet of proprietary design to effect a lancing event for the purpose of obtaining a droplet of capillary blood for diagnostic testing in children, adolescents, and adults in a home setting.

The device is designed to be cleaned and disinfected between uses on a single patient.

The Facet Aurora Reuseable Lancet Base is a blood sampling device used in conjunction with a lancet blade of proprietary design to obtain a sample of capillary blood for diagnostic purposes, primarily for blood glucose monitoring in diabetic patients.

The lancing device has been in commercial distribution in the United States for over 10 years. There have been no significant design changes over the life of the device.

The provided text describes a 510(k) premarket notification for the "Facet Aurora Reusable Lancet Base." However, it focuses on demonstrating substantial equivalence to a predicate device through non-clinical bench testing of its mechanical properties and materials. It does not contain information about:

• Acceptance criteria related to the performance of a device that uses AI/algorithm, such as sensitivity, specificity, or AUC.
• A study proving the device meets acceptance criteria for an AI/algorithm.
• Sample sizes for AI/algorithm test sets or data provenance.
• Details about experts establishing ground truth or adjudication methods for an AI/algorithm's performance evaluation.
• MRMC studies or standalone AI performance.
• Training set details for an AI/algorithm.

The device in question is a mechanical lancing device, not an AI or algorithm-based device. The non-clinical testing listed (e.g., Endcap Removal Force, Depth of Puncture, Life Cycle Test) are standard mechanical and durability tests for such a device.

Therefore, based on the provided text, I cannot describe acceptance criteria and a study that proves the device meets those criteria in the context of an AI/algorithm, as the information is not present. The document focuses on physical and mechanical properties and biocompatibility.

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