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1. CAVUX Facet Fixation System (CAVUX FFS):
   CAVUX Facet Fixation System (CAVUX FFS) is posterior spinal instrumentation with integrated screw fixation intended to provide immobilization and stabilization of spinal segments.

• CAVUX FFS is placed bilaterally through a posterior surgical approach and spans the interspace with points of fixation at each end of the construct.
• CAVUX FFS is intended for temporary stabilization as an adjunct to posterior cervical fusion in skeletally mature patients.
• CAVUX FFS is indicated for patients requiring a revision for an anterior pseudarthrosis at one level, from C3 to C7, with autogenous and/or allogenic bone graft.

2. CORUS-LX Implant:
   CORUS-LX Implant is posterior spinal instrumentation with integrated screw fixation intended to provide immobilization and stabilization of spinal segments.
   CORUS-LX is placed bilaterally through a posterior surgical approach and spans the facet interspace with points of fixation at each end of the construct.
   CORUS-LX is intended to provide temporary stabilization as an adjunct to a 1 or 2 level interbody lumbar fusion with autogenous and/or allogenic bone graft and must be accompanied with an FDA cleared intervertebral body fusion device implanted at the same spinal level(s), and may be used with a pedicle screw and rod system implanted at the same spinal level(s).
   CORUS-LX is indicated for the treatment of patients with lumbar degenerative disc disease (DDD) from L4 to S1 in skeletally mature patients who have failed conservative care.

CAVUX FFS and CORUS-LX Implant are posterior spinal instrumentation with integrated screw fixation intended to provide immobilization and stabilization of spinal segments. CORUS-LX LevelOne is a kit that contains CORUS-LX Implant and accessories.

The devices are placed through a posterior surgical approach and achieve facet fixation by spanning the facet interspace at each level with points of fixation at each end of the construct. The devices are manufactured from medical grade titanium alloy (6Al4V) and supplied sterile for single use only with pre-attached disposable delivery instruments. The implants are fenestrated and to be used with autogenous bone and/or allogenic bone graft. The design incorporates "windows" through the implant to permit visualization of the graft material and, over time, formation of new bone.

This document is an FDA 510(k) Clearance Letter for the CAVUX Facet Fixation System and CORUS-LX Implant. It is important to note that a 510(k) clearance is based on a determination of substantial equivalence to existing legally marketed predicate devices, not on a new demonstration of safety and effectiveness through clinical trials with specific acceptance criteria and performance data.

Therefore, the input document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria. The letter explicitly states:

"No new performance testing was supplied in this submission given that the subject implants have been previously cleared for the same intended use."

And further, the "Basis of Substantial Equivalence" section clarifies:

"The purpose of this submission is to modify the indications for use of the subject devices (originally cleared under K220951 and K230840) to align with language used in a more recent predicate clearance (K241035). The subject and predicate devices have similar indications for use, and the same intended use, technological characteristics, materials of construction, principles of operation, and design features and characteristics."

This means that the clearance is based on the devices being sufficiently similar to devices already on the market (the predicates) for which safety and effectiveness have been established. It does not provide details of a new study with specific acceptance criteria for the devices mentioned in this letter.

Based on the provided document, the requested information cannot be extracted. The document focuses on regulatory clearance via substantial equivalence, not on a primary study demonstrating performance against specific acceptance criteria for a new device.

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