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The SeaSpine WaveForm™ C Interbody System are interbody fusion devices intended for use in skeletally mature paient with degenerative disc disease (DDD) of the cervical spine (C2-T1) for multiple contiguous levels, depending on the system. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radios. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. These devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous, cortical, and/or corticocancellous bone.

When used as a standalone system, the WaveForm™ C Interbody System, the 2,3,4 hole TruProfile spacers and plates, are intended to be used as an adjunct to spinal fusion procedures at multiple contiguous levels of the cervical spine (C2-T), and must be used with bone screw fixation and locking covers. The No-Profile standalone interfixated spacer, is intended to be used as an adjunct to spinal fusion procedures at a single level of the cervical spine (C2-Tl), and must be used with bone screw fixation and locking covers.

When the WaveForm™ C Interbody (excluding 2-hole No-Profile interfixated spacer) is used with supplemental fixation, such as anterior cervical plates, the WaveForm C Interded to be used as an adjunct to spinal fusion procedures at multiple contiguous levels of the cervical spine (C2-TI).

The SeaSpine WaveForm™ C Interbody System is an additively manufactured implant comprised of cervical spacers. Each spacer consists of central graft windows which are packed with autogenous bone graft and/or allogenic bone graft, composed of cancellous, cortical and/or corticocancellous bone prior to implantation. The WaveForm™ C Interbody System offers spacers in low profile (TruProfile) and no profile versions in various lengths and are manufactured from Ti-6Al-4V ELI titanium alloy per ASTM F3001.

The WaveForm™ C Interbody System can be used with supplemental fixation, such as an anterior plate or as a standalone construct to be used with bone screw fixation and locking cover. The instruments included with the system facilitate the placement and adjustment of the interbody spacer, and removal if necessary. The instruments are placed in system-specific trays for storage, protection, and organization prior to and during the steam sterilization process.

This document is a 510(k) summary for the SeaSpine WaveForm™ C Interbody System, a medical device for spinal fusion. As such, it describes the device's technical specifications and demonstrates its substantial equivalence to existing predicate devices.

However, it does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of AI/machine learning performance. The document focuses on non-clinical testing of the physical device (e.g., mechanical safety) as per ASTM standards for intervertebral body fusion devices, not on the performance of a software algorithm or AI model.

Therefore, I cannot provide the requested information regarding acceptance criteria, reported AI performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment, because this document is not about an AI/ML medical device.

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