(103 days)
The Incite Interbody Fusion Device is intended for anterior intervertebral body fusion of the lumbar spine at one or two contiguous levels from L2-S1. The device is indicated for patients with lumbar degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Patients treated should be skeletally mature and have received a minimum of six months of non-operative treatment. The Incite Interbody Fusion Device is designed for use with additional supplemental fixation and with autograft to facilitate fusion.
The Incite Interbody Fusion Device (IBFD) is an ALIF implant that incorporates the benefit of a radiolucent interbody spacer equipped with internal fixation anteriorly through the use of an integrated anchoring mechanism. The implant is made from materials with a long history of use in this type of application which include PEEK, titanium alloy, and tantalum. The implant has two chambers to accommodate autograft.
I am sorry, but the provided text from the 510(k) summary (pages 0-3) for the "Incite Interbody Fusion Device" does not contain information regarding acceptance criteria, device performance, or any clinical study details such as sample sizes, data provenance, ground truth establishment, or expert involvement.
The document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to predicate devices based on design, materials, intended use, and mechanical performance. It details the device description, intended use, and lists predicate devices. It also includes the FDA's clearance letter.
Therefore, I cannot fulfill your request for the specific information about acceptance criteria and the study that proves the device meets those criteria based on the provided 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.