(80 days)
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.
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.