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The Avenue® L Interbody Fusion System is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with or without integrated fixation and must be used in conjunction with posterior supplemental fixation (e.g. pedicle screws). The device system is intended to be used with autograft to facilitate fusion.

The Avenue L Interbody Fusion System is intended for use as an interbody fusion device in the lumbar spine. The device consists of intervertebral cages manufactured from medical grade PEEK OPTIMA® LT1 (ASTM F2026) with embedded titanium alloy markers (ASTM F136) to facilitate visibility in x-ray imaging. The Avenue L is available with VerteBRIDGE titanium alloy anchoring plates which facilitate fixation to the superior and inferior vertebra, in addition to supplemental fixation. The Avenue L is designed for placement using a lateral surgical approach.

The provided text describes the LDR Spine Avenue® L Interbody Fusion System, an intervertebral fusion device. No information about AI/ML device acceptance criteria or studies involving AI performance, human readers, or ground truth establishment for AI models is present in the document.

The document mainly focuses on the regulatory submission (510(k) summary) for a medical device and describes its intended use and conformance to established standards.

Therefore, I cannot fulfill the request for information on acceptance criteria and studies proving an AI device meets those criteria. The provided text does not describe an AI/ML device.

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