(272 days)
The Rhausler RT2 Trabeculite Titanium Cervical Cage System is intended for spinal fusion procedures at one level (C3-T1) in skeletally mature patients with cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). Implants are to be implanted via an open, anterior approach and packed with autogenous bone. This device is to be used in patients who have at least 6 weeks of nonoperative treatment.
This device is intended to be used with supplemental spinal fixation systems.
The Rhausler RT2 Trabeculite Titanium Cervical Cage System is a cervical intervertebral body fusion device. The system is comprised of implants and instruments. The instruments are utilized for the implantation procedure. All implants are manufactured from medical grade Titanium alloy (Ti6 Al 4V).
The implant is rectangular in shape with lordotic configuration, i.e., with 4 degree profiles. It is offered in two cross sectional sizes and is available in various height options to accommodate variations in patient anatomy. The center of the implant has a hollow cylindrical shape fenestration for placement of autogenous bone. Trabeculite Titanium Cervical Cage implant is provided sterile.
This document is a 510(k) premarket notification for the RT2 Trabeculite Titanium Cervical Cage System. It describes the device, its indications for use, and its substantial equivalence to predicate devices. It does not contain information about an AI/ML device or its performance study.
Therefore, I cannot extract the requested information regarding acceptance criteria and performance study for an AI/ML device, as this document pertains to a medical device (cervical cage) and its mechanical and biocompatibility testing, not an AI or algorithm.
If you have a document about an AI/ML medical device, please provide that, and I will be happy to extract the relevant information.
§ 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.