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The Synthes USS (including the Click'X and USS VAS variable axis components), Click'X Monoaxial, Dual Opening and the Small Stature USS (which includes small stature and pediatric patients) are noncervical spinal fixation devices intended for use as a posterior pedicle screw fixation systems (T1-S2), a posterior hook fixation systems (TI-L5), or as anterolateral fixation systems (T8-L5). Pedicle screw fixation is limited to skeletally mature patients with the exception of the Small Stature USS. These devices are indicated for all of the following indications regardless of the intended use: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis, Scheuermann's Disease), tumor, stenosis, pseudoarthrosis, and failed previous fusion.

When treating patients with Degenerative Disc Disease (DDD), transverse bars are not cleared for use as part of the posterior pedicle screw construct.

When used with the 3.5/6.0mm parallel connectors, the Synthes USS (including the Click'X and USS VAS variable axis components), Click'X Monoaxial and Dual Opening USS can be linked to the Cervifix system. In addition, when used with 3.5/5.0 mm parallel connectors, the Synthes Small Stature USS, can be linked to the CerviFix System. When used with the 5.0/6.0mm parallel connectors, the Synthes Small Stature USS can be linked to the Synthes USS (including the Click'X and USS VAS variable axis components), the Click'X Monoaxial and Dual Opening USS Systems.

In addition, Synthes USS (including the Click'X and USS VAS variable axis components), Click'X Monoaxial and the Dual Opening USS can be interchanged with all USS 6.0mm rods and transconnectors.

The purpose of this submission is to incorporate additional Click'X Monaxial components into the Universal Spinal system. The Synthes Click'X Monoaxial system consists of a variety of shapes and sizes of rods, hooks, screws, transconnectors and connecting components. The Click'X Monoaxial implant materials are fabricated from commercially pure titanium alloy, conforming to ASTM F-67 or ASTM F-1295. respectively.

This document is a 510(k) summary for the Synthes Click'X Monoaxial System, which is a spinal fixation device. It describes the device's indications, materials, and how its performance was determined to be substantially equivalent to predicate devices. It does not contain information about specific acceptance criteria, a study proving the device meets those criteria, or details regarding ground truth establishment, expert review, or AI performance. The document explicitly states that "Comparisons of device performance data, materials, indications and design/function to predicate devices were provided in making a determination of substantial equivalence." This means the device relies on the established safety and effectiveness of its predicate devices, rather than an independent study demonstrating novel performance criteria.

Therefore, I cannot fulfill your request for the tables and details regarding acceptance criteria, study specifics, ground truth, and AI performance from the provided text, as this information is not present. The 510(k) process for this type of device typically involves demonstrating substantial equivalence to existing, legally marketed devices, rather than conducting new clinical trials with specific performance metrics and AI components as implied by your questions.

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When used as a posterior pedicle screw fixation system, the Synthes USS is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).

In addition, the Synthes USS is intended for treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine with removal of the implants after the attainment of a solid fusion. The levels of pedicle screw fixation for these patients are L3-S2.

When used as a posterior non-pedicle screw fixation system, the Synthes USS is intended for scoliotic, lordotic, or kyphotic deformities (such as scoliosis, Schuermann's disease), degenerative disc disease (back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), and fractures of the posterior thoracolumbar spine.

The Click' X components of the Synthes USS, when used as a posterior pedicle screw fixation system, are intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities of the thoracic, lumbar and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, spinal tumor and failed previous fusion (pseudoarthrosis).

In addition, the Click' X components of the Synthes USS are intended for treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine with removal of the implants after the attainment of a solid fusion. The levels of pedicle screw fixation for these patients are L3-S2.

In addition, when used with 3.5/6.0 mm parallel connectors, the Synthes USS can be linked to the CerviFix System.

The Anterior Components of the USS are intended for anterolateral screw and/or staple fixation for the correction of anterolateral for deformities for the spine, lumbar scoliosis, pseudoarthrosis, and fracture or dislocation of the thoracolumbar spine (levels T8-L5).

The Synthes USS (including Click'X components) consists of rods, hooks, side-opening screws with collar and nut, variable axis screws with rod and screw connector, collar, locking ring and nut, transconnector systems, open and closed transverse bars, parallel connectors, Schanz screws, clamp with posterior nut and associated manual surgical instruments. The implants are composed of titanium (ASTM F1295, ASTM F67) or various grades of stainless steel.

The Click' X variable axis components of the USS system are composed of titanium (ASTM F1295, ASTM F67) and consist of rods, a transconnector system, pedicle screws, back-opening 3D Heads and Locking Cap. The back-opening 3D Head is clicked on the pedicle screw in situ and attaches to the rod with a locking cap. The locking cap consists of a ring to close the back-opening screw head and an inner set screw to fix the rod and the variable axis feature of the 3D Head.

I apologize, but this document does not contain the information needed to respond to your request. The provided text is a 510(k) summary for a medical device (Synthes USS, including Click'X components) that describes its components, indications for use, and a letter from the FDA stating substantial equivalence to a predicate device.

It does not include:

• Any acceptance criteria for device performance.
• Protocols or results of a study proving the device meets acceptance criteria.
• Information on sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment for any such studies.

This document focuses on regulatory clearance based on substantial equivalence, not on a detailed clinical performance study.

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