(241 days)
Ventana™ C devices are intended for spinal fusion at one or two contiguous levels in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Implanted via an open, anterior approach for the C2-C3 disc space to the C7-T1 disc space and packed with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.
The device is intended to be used with supplemental fixation systems that have been cleared for use in the cervical spine (i.e., anterior plate systems).
Patients must have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with these devices.
The Spinal Elements' Ventana C Interbody System is an intervertebral body fusion device for use in cervical spine surgery. The device is generally box-shaped with various holes throughout its geometry to allow for the placement of autograft or allogenic bone graft. It includes a lid which further facilitates installation of bone graft, and which is shut prior to implantation. The exterior of the device has "teeth" or other generally sharp engagement members on the superior and inferior surfaces to help prevent the device from migrating once it is implanted.
The devices submitted herein are additively manufactured from titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F3001.
The provided text describes a medical device submission (K222833) for the Ventana™ C Spinal System, an intervertebral body fusion device. This document is a 510(k) summary and FDA clearance letter, which focuses on demonstrating substantial equivalence to predicate devices rather than reporting on the clinical performance of a novel AI/software device.
Therefore, the requested information regarding acceptance criteria and the study that proves the device meets the acceptance criteria (specifically pertaining to AI/software performance) cannot be extracted from this document, as it does not describe an AI or software as a medical device.
The "Performance Data" section lists various mechanical tests (Static/Dynamic Compression, Static/Dynamic Torsion, Subsidence per ASTM standards) to demonstrate the physical characteristics and safety of the implant itself, comparing it to predicate devices. It does not mention any software-related performance criteria, test sets, ground truth establishment, or human reader studies.
In summary, this document is about the physical characteristics and substantial equivalence of a spinal implant, not about the performance of an AI/software device. Therefore, I cannot provide the requested table and details related to AI/software performance.
§ 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.