(166 days)
The Wenzel Spine VariLift-C Interbody Fusion System is indicated for use in skeletally mature patients with cervical disc degeneration (DDD) and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI) that results in radiculopathy, myelopathy, and/or pain at one or multiple contiguous levels from C2/C3 to C7/T1. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).
The Wenzel Spine VariLift-C Interbody Fusion System is used to facilitate intervertebral body fusion in the cervical spine and is placed in a unilateral or a bilateral fashion via an anterior approach using autogenous and/or allogeneic bone graft comprised of cancellous, and/or corticocancellous bone graft, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. When used at one disc level, the Wenzel Spine VariLift-C interbody Fusion System may be used with or without supplemental fixation. When used at multiple contiguous levels, the Wenzel Spine VariLift-C Interbody Fusion System is intended to be used with supplemental fixation. Patients should have at least six (0) weeks of non-operative treatment prior to treatment with an intervertebral fusion device.
The VariLift® Cervical Interbody Fusion device (VariLift-C) is a self-tapping, expandable device with an interior sliding wedge. VariLift-C is cylindrical-ovoid in shape, which is adapted to the general shape of the vertebral endplates. The grooved and fluted fusion device has fenestrations (graft windows) positioned between each of its four quadrants to allow bony ingrowth and contact with the endplates. The device is manufactured from medical grade titanium alloy (Ti6Al4V) per ASTM F136.
I'm sorry, but the provided text describes the Wenzel Spine VariLift-C Interbody Fusion System, which is a medical implant (intervertebral body fusion device). The document discusses its FDA clearance (K231076) as substantially equivalent to predicate devices based on indications for use, design principles, performance, materials, and manufacturing processes.
This document does not describe an AI/ML powered device, nor does it contain information about acceptance criteria, study performance, sample sizes for test/training sets, expert ground truth establishment, or any of the other specific details regarding the validation of an AI/ML model that you are requesting.
Therefore, I cannot extract the information to fill out the table and answer your questions about acceptance criteria and study proving device performance in the context of an AI/ML powered device.
§ 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.