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The LumiVyTM 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 LumiVy™ 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 radios. The lumbar device is to be used in patients who have had six months of non-operative treatment.

Additional supplemental fixation is not necessary for the LumiVy™ - AS implants if the integrated screws are implanted.

The LumiVy™ 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. These devices also contain Tantalum wires to aid in fluoroscopic visualization. The LumiVy™ 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 spacer may be made of PEEK Optima LT1 or PEEK Optima LT1-HA with Tantalum markers. The LumiVy™ NanoVy™ Ti Lumbar IBF components are made of PEEK Optima LT1 with CP Titanium coating. The LumiVy™ Lumbar IBF System may also include bone screws manufactured from Titanium alloy to secure the device to the vertebral body.

The FDA submission for the LumiVy™ Lumbar IBF System does not contain information regarding acceptance criteria for device performance based on a study, or details of such a study. The document is a 510(k) premarket notification, which establishes substantial equivalence to predicate devices, primarily based on material, intended use, and design characteristics.

Therefore, I cannot provide:

• A table of acceptance criteria and reported device performance.
• Sample size, data provenance, or details about ground truth establishment or experts for a performance study.
• Information on adjudication methods.
• Details on multi-reader multi-case (MRMC) studies or standalone algorithm performance.
• Training set sample size or ground truth establishment for a training set.

The document states: "No additional testing was performed on the LumiVy™ Ti Lumbar IBF components." This indicates that a separate performance study with associated acceptance criteria for the device itself was not conducted for this specific 510(k) submission. Substantial equivalence was demonstrated through comparison to existing cleared predicate devices.

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