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The IO™ Expandable 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 or retrolisthesis at the involved level(s). Devices are to be used with autograft and/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 IO™ Expandable Lumbar Interbody Fusion System is an expandable lumbar interbody fusion device used to provide structural stability in skeletally mature individuals following discectomy. The IO™ Expandable Lumbar Interbody Fusion System consist of implants manufactured from titanium alloy (ASTM F136). Expansion mechanism components and the drive screw are manufactured from molybdenum rhenium (MoRe) alloy (ASTM F3273). The system is offered in various sizes to accommodate different patient anatomy requirements. Implants will be provided sterile and are intended for single use only.

This document describes the IO™ Expandable Lumbar Interbody Fusion System (K210800), a Class II medical device. The information provided outlines the performance data and equivalence to a predicate device, but it does not contain information related to software or AI performance, or any "acceptance criteria" or "study" that would involve a test set, ground truth, or expert review in the context of AI or diagnostic algorithms.

The performance data listed in the document refers to mechanical performance of the physical device, not the performance of an algorithm or software. Therefore, the requested information regarding acceptance criteria, sample size for test sets, data provenance, expert ground truth establishment, MRMC studies, standalone studies, or ground truth for training sets cannot be extracted from this document.

The provided text focuses on the device's physical and mechanical properties and its substantial equivalence to a predicate device for FDA clearance.

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