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The OneLIF™ Interbody Fusion System is an interbody fusion device system indicated for use in skeletally mature patients at one or more levels of the lumbosacral spine (L2-S1), in patients with the following indications: degenerative disc disease (DDD) defined as back pain with degeneration of the disc confirmed by patient history and radiographic studies, spinal deformity (degenerative scoliosis or kyphosis), spondylolisthesis or retrolisthesis, and failed previous fusion (pseudoarthrosis). Patients should have received 6 months of nonoperative treatment prior to treatment with the devices.

The OneLIF™ Interbody Fusion System is intended to be used with or without the screws which accompany the implants. These devices are intended for stand-alone use in patients with DDD or degenerative spondylolisthesis at one or two contiguous levels only when used with at least three screws per implant (including at least one screw in each endplate) and when ≤ 20° lordotic implants are used. When used at more than 2 contiguous levels, or for treatment of conditions other than DDD or degenerative spondylolisthesis, or with fewer than 3 accompanying screws, or when using implants greater than a 20° lordotic angle, the system must be supplemented by posterior fixation (e.g., pedicle screw system) cleared for use in the lumbar spine.

The implants can be placed via a variety of open or minimally invasive approaches. These include anterior and oblique approaches. The implant is designed for use with autograft bone and/or allogenic bone graft comprised of cancellous or corticocancellous bone graft.

The OneLIFTM Interbody implant system includes interbody cages that provide six holes designed to accept bone screws of various styles and sizes.

The titanium allov (per ASTM F1472) OneLIF™ Interbody implant system includes an interbody that provides six holes designed to accept bone screws of various styles and sizes. The titanium alloy (per ASTM F1472) Retention Plate fastens to the Interbody with a Retention Plate Screw.

The provided text describes the 510(k) summary for the OneLIF™ Intervertebral Body Replacement System, a medical device for spinal fusion. However, it does not contain any information about an AI/ML-driven device or study results related to AI/ML performance. The document focuses on the mechanical performance testing of the intervertebral body replacement system (such as ASTM F2077 and ASTM F2267) to establish its substantial equivalence to predicate devices, which are physical implants, not software.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or answer questions regarding sample size, data provenance, expert adjudication, MRMC studies, standalone performance, ground truth establishment, or training set details, as these are all related to the evaluation of an AI/ML system, which is not described in this document.

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