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The ENDOTINE Midface™ B 4.5 is intended for use in subperiosteal midface suspension surgery. Specifically, the ENDOTINE Midface™ B 4.5 is indicated for use in suspending the subcutaneous tissues of the midface from the infra-orbital rim or zygoma via an anchoring leash.

The ENDOTINE Midface™-ST 4.5 consists of two components: (1) a fixation platform with anchoring leash, and (2) a screw anchor. This device is supplied sterile for single use only.

The ENDOTINE Midface™ B Instrument Kit is packaged separately from the implant device and is provided to the user non-sterile. The kit is comprised of the following tools that aid in the deployment and anchoring of the implant device:

• Sterilization tray (lid, base and mat) to house the instruments for transport and . sterilization
• Drill bit for creating a hole in the infra-orbital rim .
• Tapping tool to create the threads in the drilled hole to conform to the anchor . screw
• . Insertion tool to grasp and deploy the anchor screw
• Clipper tool to remove the screw flange and excess leash length .

The provided text does not contain information about acceptance criteria or a study proving device performance in the context of an AI/ML device.

This document is a 510(k) Premarket Notification for a medical device called "ENDOTINE Midface™ B 4.5 Device", which is a surgical implant for midface suspension.

The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices (other surgical implants) based on:

• Indications for Use: Stating they are "nearly identical" and substantiated by "bench and performance testing."
• Technological Characteristics: Highlighting similar "design, materials and fundamental scientific technology."
• Performance Summary: Stating that a comparative performance study "raised no different questions of safety or effectiveness" and "the results suggest the ENDOTINE Midface™ B 4.5 performs as well as the selected predicate for its intended use."

However, it does not provide details about specific acceptance criteria or the results of any performance study in a quantifiable manner, nor does it involve any AI/ML components.

Therefore, I cannot populate the requested table or answer the specific questions related to AI/ML device performance, sample sizes, ground truth establishment, or human reader effectiveness studies.

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