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SPIRA Open Matrix ALIF: The Camber Spine Technologies SPIRA™ Open Matrix ALIF is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radios. Patients should have received 6 months of nonoperative treatment prior to treatment with the devices. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The Camber Spine Technologies SPIRA™ Open Matrix ALIF is intended to be used with additional FDA-cleared supplementary fixation systems. The Camber Spine Technologies SPIRA™ Open Matrix ALIF system must be used with autogenous bone graft or allogenic bone graft composed of cancellous and/or corticocancellous bone graft.

SPIRA Open Matrix LLIF: The Camber Spine Technologies SPIRA Open Matrix LLIF is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radios. Patients should have received 6 months of nonoperative treatment prior to treatment with the devices. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The Camber Spine Technologies SPIRA Open Matrix LLF is intended to be used with additional FDA-cleared supplementary fixation systems. The Camber Spine Technologies SPIRA Open Matrix LLIF system must be used with autogenous bone graft or allogenic bone graft composed of cancellous and/or corticocancellous bone graft.

SPIRA Open Matrix ALIF is an interbody fusion device with an open matrix design consisting primarily of arched support members to permit bone growth (i.e., interbody fusion) throughout the implant, SPIRA Open Matrix ALIF. With the exception of the perimeter, all surfaces have a roughened texture to help prevent movement of the device.

SPIRA Open Matrix LLIF is an interbody fusion device with an open matrix design consisting primarily of spiral support members to permit bone growth (i.e., interbody fusion) throughout the implant, SPIRA-L Open Matrix LLIF.

The purpose of this submission is the addition of the allogenic bone graft indication to both SPIRA ALIF and SPIRA LLIF devices that have been cleared under K162986 and K180724 respectively.

The provided text is a 510(k) summary for a medical device (SPIRA Open Matrix ALIF and LLIF) and does NOT contain information about acceptance criteria or a study proving that a device meets those criteria, particularly in the context of an AI/algorithm-driven device.

The document describes the device, its indications for use, and a comparison to predicate devices for substantial equivalence. It briefly mentions "Performance Data" but this refers to a Finite Element Analysis (FEA) performed to evaluate the effects of design changes on the implant, not an AI or algorithm's performance against clinical endpoints or ground truth.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets them based on the provided text, as this information is not present. The questions you posed are typically relevant for AI/ML-driven medical devices, which this submission is not.

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