Search Results

The 4CIS® Spinal System and 4CIS® Low Back System is a pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-S I vertebra in skeletally mature patients receiving fusion by the autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

In addition, the 4CIS® Spinal System and 4CIS® Low Back System 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 the objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis).

The 4CIS® Spinal System and 4CIS® Low Back System are a top-loading multiple component, posterior spinal fixation systems which consist of pedicle screws, rods, locking spacer, and a transverse (cross) linking mechanism.

The 4CIS® Spinal System and 4CIS® Low Back System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The 4CIS® Spinal System and 4CIS® Low Back System implant components are supplied in the non-sterile condition for a single use and are fabricated from titanium alloy (Ti-6A1-4V ELI) that conforms to the ASTM F136. Various sizes of these implants are available. Specialized instruments are also available for the application and removal of the 4CIS® Spinal System and 4CIS® Low Back System.

The provided text is a 510(k) summary for the 4CIS® Spinal System and 4CIS® Low Back System. It describes the device, its intended use, and states that mechanical testing was conducted to demonstrate substantial equivalence to predicate devices. However, this document does not contain information related to an AI/ML device or a study involving acceptance criteria for an AI/ML device's performance metrics.

The document discusses:

• Device Identification: 4CIS® Spinal System and 4CIS® Low Back System (pedicle screw spinal fixation system).
• Predicate Devices: Global Spinal Fixation System (K001668) and OPTIMA™ Spinal System (K031585).
• Device Description: Top-loading multiple component, posterior spinal fixation systems consisting of pedicle screws, rods, locking spacer, and a transverse linking mechanism made from titanium alloy (Ti-6A1-4V ELI).
• Indications for Use: Treatment of severe Spondylolisthesis (Grade 3 and 4) of L5-S1 vertebra and as an adjunct to fusion for various spinal instabilities or deformities (degenerative Spondylolisthesis, fracture, dislocation, scoliosis, kyphosis, spinal tumor, failed previous fusion).
• Performance Data: States "Mechanical testing as listed in APPENDIX 10 that was conducted in accordance with ASTM F1717 demonstrates the substantial equivalence to the above predicate devices."

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving device performance for an AI/ML device, as the document pertains to a traditional medical device (pedicle screw spinal fixation system) and its mechanical testing for substantial equivalence. The document does not mention any AI/ML components or performance metrics for such a system.

Ask a specific question about this device