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The FortiVy™ OsteoVy™ Lumbar IBF System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device systems are designed for use with autogenous bone graft to facilitate fusion. The implants are intended to be used with legally cleared supplemental spinal fixation cleared for the implanted level.

The FortiVy™ OsteoVy™ Lumbar IBF System is also intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is to be used in patients who have had six months of non-operative treatment.

Hyperlordotic interbody devices (>20° lordosis) must be used with at least anterior supplemental fixation or anterior buttress plate with posterior supplemental fixation.

The FortiVy™ OsteoVy™ Lumbar IBF System device is intended to be used as an intervertebral body fusion device. The device is surgically implanted between vertebral bodies from an anterior, lateral, or posterior surgical approach. The FortiVy™ OsteoVy™ Lumbar IBF System device is available in multiple anatomical shapes and sizes to accommodate various vertebral bodies. These include smaller cylindrical and rectangular shapes, elongated elliptical shapes, and larger hemi-cylindrical shapes. The FortiVy™ OsteoVy™ Lumbar IBF components are additively manufactured using Titanium 6Al-4V ELI conforming to ASTM F3001-14. The FortiVy™ OsteoVy™-Ti NanoVy™-HA Lumbar IBF device has been treated with a 20-40 nanoscale topography on the entirety of the implant surface, in addition to macro-/micro-scale topography existing from prior to treatment.

The provided text is a 510(k) summary for a medical device (FortiVy™ OsteoVy™ Lumbar IBF System). It describes the device, its intended use, and states that non-clinical testing was performed to demonstrate substantial equivalence to predicate devices.

However, this document does not contain information about studies involving AI or software, nor does it mention acceptance criteria related to AI performance, sample sizes for AI model validation, expert ground truth establishment, MRMC studies, or standalone algorithm performance.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving the device meets those criteria in the context of an AI/software device. The document explicitly states: "This device does not contain software or electrical equipment."

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