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The Vail ALIF Buttress Plate System in conjunction with tradition is intended for use in spinal fusion procedures of the thoracolumbar to S1 spinal region as a means to maintain the relative position of weak bony tissue such as allografts or autografts. This device is not intended for load bearing applications.

The Vail ALIF Buttress Plate System is an anterior non-load bearing plate system manufactured from Titanium Alloy 6AL-4V ELI per ASTM F136. The implants are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient. The Vail ALIF Buttress Plate System is provided non-sterile, for single use only.

This is a 510(k) premarket notification for a medical device (Vail ALIF Buttress Plate System), not a study evaluating software or AI performance. Therefore, the requested information about acceptance criteria, device performance, sample sizes, expert involvement, and ground truth establishment, which are typical for studies of AI/software devices, is not available in this document.

The document describes the device, its intended use, and compares it to predicate devices based on design and material. It also mentions "performance data" but these refer to mechanical tests of the physical implant, not clinical or algorithmic performance from a study.

Here's a breakdown of what is provided regarding "performance data" in this document:

• Acceptance Criteria and Reported Device Performance: This section is not applicable in the context of an AI/software device. The document states:
  • Acceptance Criteria for the Vail ALIF Buttress Plate System: "met all specified criteria" for "Static Cantilever Bending" and "Dynamic Cantilever Bending." The specific numerical criteria are not detailed in this summary but would have been part of the full 510(k) submission.
  • Reported Device Performance: The device withstood static and dynamic cantilever bending without failure, demonstrating "a safety and effectiveness profile that is equivalent to the predicate device."
• Study That Proves the Device Meets the Acceptance Criteria: The study mentioned is a series of mechanical performance tests, specifically:
  • Static Cantilever Bending
  • Dynamic Cantilever Bending
  • No details about the sample size (number of devices tested), data provenance, or explicit ground truth are provided, as these are material and mechanical tests, not clinical efficacy studies or AI performance evaluations.

The remaining requested information (2-9) is not applicable or present in this 510(k) summary because it pertains to the evaluation of AI/software performance, which this device is not.

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