Search Results

The Innovasis CxHA™ PEEK Cervical IBF System is indicated for cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies.

This device is to be used in patients who have had six weeks of non-operative treatment. The CxHA device is to be used with supplemental fixation, such as the Innovasis Opteryx® Cervical Plate System. The CxHA device is intended to be used with autograft bone and is to be implanted via an anterior approach.

The CxHA PEEK Cervical IBF System is a spinal intervertebral fusion device made from hydroxyapatite infused polyetheretherketone. It is provided in a variety of footprint sizes ranging from 12mm anterior-posterior x 14mm medial-lateral to 16mm anterior-posterior x 19mm medial-lateral. It is provided in heights from 6mm to 12mm in 1mm size increments with 8° lordosis. There is an interior cavity for use with autogenous bone graft material. It has two radiographic marker spheres made from tantalum per ASTM F560.

There is no information in the provided text about acceptance criteria or a study that proves a device meets those criteria. The document is a 510(k) premarket notification for a medical device (CxHA™ PEEK Cervical IBF System), which aims to demonstrate substantial equivalence to predicate devices, not to establish performance against specific acceptance criteria in a clinical study.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth for either test or training sets.

Ask a specific question about this device