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The XIPHOS™ ZFUZE™ 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 is designed for use with supplemental fixation and with autograft to facilitate fusion.

The XIPHOS™ ZFUZE™ Interbody Fusion System is a single use sterile- packed permanent implant identical to that of the construct in the cleared XIPHOS™ Interbody Fusion system (K100042). The DiFUSION Technologies XIPHOS™ ZFUZE™ Interbody Fusion System is comprised of various sizes and configurations to accommodate individual patient anatomy. The configurations are designed to provide the surgeon with different surgical approach options. The XIPHOS™ ZFUZE™ Interbody Fusion System will be offered in two (2) configurations of various sizes like its predicate XIPHOS™. The configurations are designed based on indicated spinal implant level and surgical approach, and consist of: 1) XIPHOS™ ZFUZE™ PLIF, posterior lumbar approach and 2) XIPHOSTM ZFUZE™ TLIF, transforaminal lumbar approach.

XIPHOS™ ZFUZE™ Interbody Fusion System implants consist of bullet shaped (PLIF) and banana shaped (TLIF) blocks in a parallel configuration of various heights. Large bone graft windows are located through the body of the device to allow for placement of bone graft to facilitate fusion. The superior and inferior surfaces of the devices have a pattern of teeth to provide increased stability and inhibit movement of the implants.

Additionally, the device contains four (4) radiolucent tantalum markers in the PLIF configuration and five (5) radiolucent tantalum markers in TLIF configuration to assist the surgeon with proper placement of the device. The PLIF device may be implanted singularly or in pairs via a posterior approach while The TLIF device may be implanted singularly via a transforaminal approach.

The XIPHOS™ ZFUZE™ Interbody Fusion System is made of Ketaspire PEEK (KT1211FP) and Type 4A Zeolite. In addition tantalum beads are embedded in the spacers to allow radiographic visualization. These permanent implants are available for prescription use only.

This document is a 510(k) premarket notification for a medical device, specifically an intervertebral body fusion system. It does not contain information about acceptance criteria or a study proving that an AI/Software as a Medical Device (SaMD) meets acceptance criteria.

The document describes the XIPHOS™ ZFUZE™ Interbody Fusion System, which is a physical implant used for spinal fusion. The "performance data" section clearly states that the testing was mechanical testing (e.g., Static Compression, Dynamic Compression, Wear Debris) and biocompatibility assessment for the physical device, not an AI algorithm.

Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving device (AI/SaMD) performance, as this information is not present in the provided text.

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