(146 days)
The Expandable PEEK-OPTIMA® Implant is indicated for vertebral body replacement and intervertebral fusion. When used for vertebral body replacement, The Expandable PEEK-OPTIMA® Implant is indicated for use in the thoracolumbar spine (i.e., T1 to L5) to replace a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Expandable PEEK-OPTIMA® Implant is also indicated for treating fractures of the thoracic and lumbar spine. The Expandable PEEK-OPTIMA® Implant is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period.
As an intervertebral body fusion device, the Expandable PEEK-OPTIMA® Implant is indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.
The Expandable PEEK-OPTIMA® Implant is designed for use with autograft to facilitate fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine.
The Expandable PEEK-OPTIMA® Implant is a rectangular, expandable device constructed of medical grade Polyetheretherketone (PEEK), for spinal applications.
I am sorry, but the provided text does not contain information about acceptance criteria or a study proving device performance against such criteria. The document is a 510(k) Summary for the "Expandable PEEK-OPTIMA® Implant," outlining its description, indications for use, and a claim of substantial equivalence to predicate devices, primarily based on technological characteristics and mechanical testing for equivalence, not detailed performance criteria or clinical study results.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, nor can I provide the associated details about sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth information.
§ 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.