(225 days)
The Life Spine Stand-Alone Spacer System System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). It is to be used in patients who have had at least six months of non-operative treatment. This device is intended to be used with autogenous bone graft.
The Life Spine Stand-Alone Spacer System is intended for use with four titanium alloy screws which are provided with the system. If the physician chooses to use fewer than four of the provided screws, then a supplemental internal spinal fixation system that is cleared for use in the lumbosacral spine must be used.
The Life Spine Stand-Alone Spacer System implants are intervertebral body fusion devices comprised of a variety of spacer implants manufactured from Polyetheretherketone (PEEK-OPTIMA LT1) with tantalum markers. The spacers are hollow to permit packing with bone graft to help promote intervertebral body fusion. The superior and inferior surfaces have teeth to assist in the interface with the vertebral endplates to help prevent rotation and/or migration. Additionally, the implants incorporate a titanium alloy (6AL-4V-ELI per ASTM F-136) anterior fixation plate which has integrated screw holes to allow for placement of four titanium alloy screws that anchor the implant to the adjacent vertebrae. The implants are available in a range of sizes and footprints to suit the individual pathology and anatomicial conditions of the patient.
The provided text is a 510(k) summary for the Life Spine Stand-Alone Spacer System. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does NOT contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or multi-reader multi-case studies.
The document states: "The Life Spine Stand-Alone Spacer System was shown to be substantially equivalent to previously cleared devices in indications for use, design, function, and materials used." This implies that the approval was based on demonstrating equivalence to existing devices, rather than new performance studies with specific acceptance criteria.
Therefore, I cannot provide the requested information from the given text.
§ 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.