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When used as a pedicle screw fixation system in skeletally mature patients, the Dynesys® Spinal System is intended to provide immobilization and stabilization of spinal segments 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 and failed previous fusion (pseudarthrosis).

In addition, when used as a pedicle screw fixation system, the Dynesys system is indicated for use in patients:

• Who are receiving fusions with autogenous graft only; ●
• Who are having the device fixed or attached to the lumbar or sacral spine; .
• Who are having the device removed after the development of a solid fusion . mass.

When the Dynesys Spinal System and the OPTIMA ZS Spinal System are used on contiguous levels, they must be used with the Zimmer® DTO™ Implant, rodacord combination implant, and the U & I Corporation OPTIMA ZS Transition Screw. The indications for use for each level is as specified for each system.

The Zimmer DTO Implant is a cord-rod combination implant that is assembled intraoperatively by the final tightening of the fastening pin that secures the connection of the cord and the rod. The U & I Corporation OPTIMA ZS Transition Screw is a pedicle screw that is part of the OPTIMA ZS Spinal System. When the Dynesys Spinal System and the OPTIMA ZS Spinal System are implanted on contiguous levels the Zimmer DTO Implant and the OPTIMA ZS Transition Screw are used at the interface of these two systems. The cord portion of the Zimmer DTO Implant interfaces with the Dynesys Spinal System. The rod portion of the Zimmer DTO Implant interfaces with the OPTIMA ZS Transition Screw and with the OPTIMA ZS Spinal System.

The provided text is a 510(k) summary for the Zimmer® DTO™ Implant, a spinal fixation system. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

The 510(k) summary focuses on demonstrating substantial equivalence to previously cleared devices based on design, materials, function, and intended use, rather than presenting a detailed clinical or performance study with defined acceptance criteria.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them using the provided text. The requested information is simply not present in this regulatory submission.

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