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FORZA XP Expandable Spacer System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved levels. These patients may have had a previous non-fusion surgery at the involved level(s).

FORZA XP Expandable Spacer System is intended for use with autograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation (i.e. Firebird® Spinal Fixation System).

Patients must have undergone a regimen of at least six months of non-operative treatment prior to being treated with FORZA XP Expandable Spacer System.

The FORZA XP Expandable Spacer System consists of various size and style options to address the clinical and anatomic needs of individual patients. The implant is rectangular in its general shape with the capability to expand in height continuously within its design limitations. The implant incorporates bone graft cavities through the superior and inferior surfaces to allow fusion between adjacent vertebral bodies. The implant incorporates a posterior opening to allow the addition of bone graft material post expansion. The implants are manufactured from implantable grade Ti6Al4V alloy and PEEK Optima LT1. The implants are delivered pre-assembled, unexpanded and are designed with textured bone contacting surface to resist migration /expulsion post operatively.

The provided text describes a 510(k) premarket notification for the "FORZA® XP Expandable Spacer System," an intervertebral body fusion device. This document details the device's characteristics, intended use, and its substantial equivalence to legally marketed predicate devices based on non-clinical performance data.

However, the information provided does not contain any details about an AI/ML-driven device, nor does it discuss clinical studies with human readers, ground truth establishment, or specific acceptance criteria for AI model performance.

The document specifically mentions:

• "Based on design change and risk assessment the mechanical tests performed were Static and Dynamic Axial Compression Tests and Static and Dynamic Compression Shear Tests in accordance to the ASTM F2077-14 standard for Test Method for Intervertebral Body Fusion Devices."

This indicates that the "performance data" refers to mechanical testing of the physical implant device, not to the performance of an AI/ML algorithm.

Therefore, I cannot fulfill your request for information regarding acceptance criteria and a study that proves an AI/ML device meets those criteria based on the provided text. The provided text describes a physical medical device (an intervertebral spacer) and its mechanical testing for compliance with an ASTM standard, which is unrelated to AI/ML performance evaluation.

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