(58 days)
The GetSet GoLIF! Lumbar Interbody Fusion (IBF) system is indicated for interbody fusion with autograft and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft in patients with symptomatic Degenerative Disc Disease (DDD) at either one or two contiguous levels in the lumbar spine, from L1-L2 to L5-S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via an open or a minimally invasive posterior approach. Alternatively, these implants may also be implanted via a transforaminal approach. These devices are intended to be used with supplemental posterior fixation, which has been cleared by the FDA for use in the lumbar spine.
The GoLIF! Lumbar Interbody Fusion System are sterile implantable cages and sterile instruments intended to be inserted into the intervertebral body space of the lumbosacral spine and intended for intervertebral body fusion. The GetSet GoLIF! implants are designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column. The implants are designed for a unilateral posterior transforaminal (TLIF) approach or posterior lumbar interbody fusion (PLIF) approach. It is specially designed for small incision (minimally invasive), resulting in a relatively atraumatic operation for the patient. Implants, used with supplemental fixation and bone graft, provide improved stability, height restoration and lordosis to optimize fusion. Based on anatomical reasons, implants will be offered in lengths of 22mm and 26mm, heights of 8-14mm in 1mm increments, and at a width of 10mm. The implant has a tapered tip to allow distraction upon insertion, and teeth on the superior and inferior surfaces help the implant to resist implant migration. The dome shape allows for 7-18 degree lordosis when placed at a TLIF Oblique or PLIF position whilst maintaining coronal alignment due to the neutral region in the mid-section of the implant when positioned in a lateral position. The openings allow for packing of bone graft. The GoLIF! Lumbar Interbody Fusion System also includes instruments to facilitate implantation of the subject implant devices. Instruments are manufactured from Polyacrylamide (IXEF), Polybutylene terephthalate (PBT), and medical grade stainless steel.
The provided text is a 510(k) premarket notification letter and summary for the GoLIF! Lumbar Interbody Fusion System. It details the substantial equivalence determination for a medical device (an intervertebral body fusion device), not an AI/Software as a Medical Device (SaMD).
Therefore, the document does not contain information on:
- Acceptance criteria for an AI/SaMD and reported device performance against those criteria.
- Sample size, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or ground truth details for an AI/SaMD.
- Training set sample size or how ground truth was established for a training set.
The document does mention performance testing, but this refers to mechanical testing (static and dynamic axial compression, compression shear, subsidence, and expulsion) conducted per ASTM standards and Limulus Amebocyte Lysate (LAL) testing to confirm endotoxin levels. These are standard tests for physical implants to ensure their mechanical integrity and biocompatibility, not for evaluating the performance of AI/software.
In summary, the information requested relates to the validation of an AI/SaMD, which is not the subject of this document. This submission is for a physical medical implant.
§ 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.