(93 days)
The NuVasive CoRoent Small Contoured Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The CoRoent Small Contoured Interbody System is intended for use for anterior cervical interbody fusion in patients with cervical degenerative disc disease (DDD) at one level from C2 - TI. The System is intended to be used with supplemental fixation. The System is intended for use with autogenous and/or allogeneic bone graft comprised of cancellous, cortical and/or corticocancellous bone graft to facilitate fusion. The cervical devices are to be used in patients who have had at least six weeks of non-operative treatment.
The NuVasive CoRoent Small Contoured Interbody System is a hollow interbody cage manufactured from PEEK-Optima® LT-1 conforming to ASTM F2026. The implant contains a hollow core or graft aperture which allows for packing of autograft to help promote a solid fusion. Rows of teeth on the surface of each end of the device serve to grip the adjacent vertebrae to resist migration and expulsion of the device. The device includes marker pins composed of titanium alloy conforming to ASTM F136 and ISO 5832-3 or tantalum conforming to ASTM F560 or ISO 13782. The pins serve as radiopaque markers allowing the location and orientation of the device to be seen radiographically during and after the procedure for position confirmation.
The implants are available in flat or contoured endplates, and come in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient. The subject device will be packaged and initially provided non-sterile, and is designed to be sterilized by the user before each use.
This document describes the NuVasive CoRoent Small Contoured Interbody System, an intervertebral body fusion device. While it contains information about the device's intended use and performance data, it does not describe an AI/ML device or a study that evaluates its performance against specific acceptance criteria in the context of AI/ML.
Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, expert involvement, or ground truth as typically associated with AI/ML device evaluations.
The document primarily focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing and a clinical literature review for a medical implant, not an AI-powered diagnostic or assistive tool.
Specifically, the document states:
- "This device does not contain software or electrical equipment." (Page 4, Section F) This explicitly confirms it is not an AI/ML device.
Therefore, a table of acceptance criteria and reported device performance for an AI/ML device cannot be extracted from this document, nor can the details of an AI/ML study.
§ 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.