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The MiRus™ 3D Printed Lumbar Interbody Fusion System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L1-L2 to L5-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). Devices are to be used with autogenous or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral body fusion device.

The MiRus™ 3D Printed Lumbar Interbody Fusion System consist of implants manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F3001-14 and are offered in four configurations of various sizes to accommodate different patient anatomy and the surgical approaches listed; Posterior Lumbar Approach (PLIF), Transforaminal Lumbar Approach (TLIF), Lateral Lumbar Approach (LLIF), and Anterior Lumbar Approach (ALIF). The implants are provided sterile and are intended for single use only.

The provided text does not contain information about acceptance criteria for an AI/ML device, nor does it describe a study proving such a device meets acceptance criteria.

Instead, the document is a 510(k) summary for the MiRus™ 3D Printed Lumbar Interbody Fusion System, a medical device for spinal fusion procedures. The content focuses on demonstrating substantial equivalence to predicate devices, primarily through mechanical performance testing, rather than evaluating an AI/ML algorithm.

Therefore, I cannot provide the requested information.

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