(214 days)
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.
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.