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FIDJI types 1, 2, 3, and 4 are vertebral body replacement devices that are intended for use in the thoracic and/or thoracolumbar spine (T1-L5) to replace a collapsed, damaged or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., fracture). The device is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period. These devices are intended to be used with bone graft and supplemental fixation, such as the Spinal Concepts, Inc. InCompass System.

The FIDJI Vertebral Body Replacement Types 1, 2, 3, and 4 devices are hollow blocks that are machined from PEEK OPTIMA® (polyetheretherketone, ASTM F2026); the blocks are tapered to aid in maintaining lordosis of the spine following implantation. The devices have angled teeth on the cephalad and caudal surfaces. The devices include tantalum inserts that serve as a location and orientation markers for radiographs.

The provided text describes a 510(k) premarket notification for a medical device called "FIDJI Vertebral Body Replacement Types 1, 2, 3, and 4." This document primarily focuses on demonstrating substantial equivalence to predicate devices and detailing the device's design, intended use, and mechanical testing.

It does not contain information about a study proving the device meets acceptance criteria in the context of an AI/algorithm-based diagnostic or assistive system.

Therefore, I cannot provide the requested information in the format of the table and points because the document is not about an AI-powered device or a study involving human readers or ground truth for an AI system.

The document's "Mechanical Testing" section states: "Mechanical testing demonstrated that FIDJI types 1,2,3, and 4 exhibit the functional requirements to support their use as vertebral body replacements under normal physiologic loads in the spine." This indicates that physical, laboratory-based testing was conducted to ensure the device's structural integrity and performance, which is typical for implantable medical devices. However, this is not related to the type of AI/algorithm study information you've requested (e.g., sample size for test/training set, expert consensus, MRMC studies).

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