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FFX is a lumbar facet system that is placed bilaterally through a posterior surgical approach and spans the facet interspace with the component FFX screw through the component FFX facet cage. FFX is intended to provide temporary fixation and stabilization to the spine as an aid to lumbar fusion through bilateral immobilization of the facet joints at one or two levels with autogenous and/or allogenic bone graft. FFX is indicated for the treatment of patients with lumbar degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies and/or degenerative disease of the facet with instability from L3 to S1 in skeletally mature patients who have failed conservative care.

The FFX Facet Fixation system consists of an FFX Cage and an FFX Facet Screw.

The cage component of the FFX implant is a sterile, single patient use, long-term implantable device made of titanium. The cage has a D-shape that is designed to be packed with autogenous and/or allogenic bone graft. The top and bottom surfaces of the cage have teeth to improve fixation to the bone. The cage contains a bullet nose to ease insertion.

FFX Cages are titanium devices available in several sizes to ensure proper fit in the facet joint space. The implant is positioned between the facet joints, with its apex oriented anteriorly. The cage is surgically placed in the facet joint in combination with autogenous and/or allogenic bone graft material inside and posterior to the implant. Two devices are used per level with the FFX screw through the cage lumen. They are implanted between the two facets to be stabilized and can contain autogenous and/or allogenic bone graft.

The FFX Facet Screw is a self-compressive, self-tapping, headless and cannulated screw with a continuous progressive thread. It is made of titanium alloy (EN ISO 5832-3). It is provided sterile and intended for long-term implantation.

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SC Medica FFX is a lumbar facet device that is placed bilaterally through a posterior surgical approach and spans the facet interspace. SC Medica FFX must be used with an FDA-cleared transfacet screw cleared for use in the lumbar spine. SC Medica FFX is intended to provide temporary fixation to the spine as an aid to lumbar fusion through bilateral immobilization of the facet joints at one or two levels with autogenous and/or allogenic bone graft. SC Medica FFX must be accompanied with an FDA-cleared intervertebral body fusion device and/or with an FDA-cleared posterior lumbar pedicle screw and rod system implanted at the same spinal level(s) as an adjunct to a single or two-level intervertebral body or posterolateral fusion, respectively. SC Medica FFX is indicated for the treatment of patients with lumbar degenerative disc disease (DDD) from L3 to S1 in skeletally mature patients who have failed conservative care.

FFX implants are intended to provide temporary fixation and stabilization to the spine as an aid to lumbar fusion through bilateral immobilization of the facet joints. The FFX implant is a sterile, single patient use, long-term implantable device made of titanium.

The provided document is a 510(k) premarket notification for the SC Medica FFX device. It does not contain any information related to acceptance criteria, a study proving the device meets acceptance criteria, or any of the detailed aspects of a clinical or analytical performance study (like sample size, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details, etc.).

The document focuses on demonstrating substantial equivalence to predicate devices through non-clinical bench testing (sterilization, biocompatibility, shelf-life, and mechanical testing) and states that "clinical data demonstrated a substantially equivalent safety and effectiveness profile". However, it does not provide any specifics about this "clinical data" (e.g., patient numbers, study design, endpoints, statistical analysis, or any of the ground truth or reader study details requested).

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and a study that proves the device meets those criteria based on the provided text. The document primarily confirms the FDA's clearance of the device based on substantial equivalence, rather than detailing a specific performance study against defined acceptance criteria.

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