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When used as a vertebral body replacement, the Mosaic device is 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).

This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). The interior of the spacer can be packed with allograft or autograft

When used as an intervertebral body fusion device, the Mosaic device is intended for spinal fusion procedures at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be implanted via an open, anterior approach and packed with autogenous bone.

Spinal Elements' Mosaic device is a generally box-shaped device with various holes located throughout its geometry and teeth on the superior and inferior surfaces. The device body has projections (or flanges) that encompass screw holes and may be made from titanium alloy (Ti-6Al-4V) or polyetheretherketone (PEEK).

The Mosaic system is provided with bone screws that are manufactured from titanium alloy (Ti-6Al-4V), and are available in both fixed and variable angle designs.

The provided document is a 510(k) Premarket Notification for the Mosaic™ Intervertebral Body Fusion Device, along with an FDA clearance letter. It describes the device, its intended use, and states that it was found "substantially equivalent" to predicate devices. The document explicitly states "Mechanical testing indicates that the Mosaic device is capable of performing in accordance with its intended use."

However, this document does not contain information regarding acceptance criteria and a study that proves the device meets those criteria in the context of an AI-powered device. The device described is a physical intervertebral body fusion device and not an AI/ML medical device. Therefore, the requested information about test sets, ground truth, expert adjudication, MRMC studies, and standalone algorithm performance, which are relevant to AI/ML device evaluations, cannot be extracted from this submission.

The document only discusses mechanical testing, which is a different type of performance evaluation relevant to physical implants.

Therefore, I cannot provide the requested information for acceptance criteria and a study proving an AI/ML device meets them based on the input text.

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